Increased variability in A1c and FPG is a risk factor for severe hypoglycemia

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Key clinical point: In patients with type 2 diabetes (T2D), increased visit-to-visit variability in glycated hemoglobin (A1c) and fasting plasma glucose (FPG) was associated with a higher risk for severe hypoglycemia; however, FPG variability better predicted severe hypoglycemic events than A1c variability.

 

Major finding: Each standard deviation (SD) increase in the variability in A1c and FPG significantly increased the risk for hypoglycemia requiring any third-party assistance (adjusted hazard ratio [aHR] 1.10 and aHR 1.40, respectively; both P < .01) and hypoglycemia requiring medical assistance (aHR 1.11 and aHR 1.46, respectively; both P < .01). However, FPG variability better predicted severe hypoglycemic events than A1c variability (P < .01).

 

Study details: Findings are from a post hoc analysis of the ACCORD trial including patients with T2D and a high risk for cardiovascular disease, of which 10,052 and 10,068 patients were included in A1c and FPG variability analyses, respectively.

 

Disclosures: This study was partly supported by the National Science Foundation of China project. The authors declared no conflicts of interest.

 

Source: Long C et al. Association of long-term visit-to-visit variability of HbA1c and fasting glycemia with hypoglycemia in type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2022;13:975468 (Aug 11). Doi: 10.3389/fendo.2022.975468

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Key clinical point: In patients with type 2 diabetes (T2D), increased visit-to-visit variability in glycated hemoglobin (A1c) and fasting plasma glucose (FPG) was associated with a higher risk for severe hypoglycemia; however, FPG variability better predicted severe hypoglycemic events than A1c variability.

 

Major finding: Each standard deviation (SD) increase in the variability in A1c and FPG significantly increased the risk for hypoglycemia requiring any third-party assistance (adjusted hazard ratio [aHR] 1.10 and aHR 1.40, respectively; both P < .01) and hypoglycemia requiring medical assistance (aHR 1.11 and aHR 1.46, respectively; both P < .01). However, FPG variability better predicted severe hypoglycemic events than A1c variability (P < .01).

 

Study details: Findings are from a post hoc analysis of the ACCORD trial including patients with T2D and a high risk for cardiovascular disease, of which 10,052 and 10,068 patients were included in A1c and FPG variability analyses, respectively.

 

Disclosures: This study was partly supported by the National Science Foundation of China project. The authors declared no conflicts of interest.

 

Source: Long C et al. Association of long-term visit-to-visit variability of HbA1c and fasting glycemia with hypoglycemia in type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2022;13:975468 (Aug 11). Doi: 10.3389/fendo.2022.975468

Key clinical point: In patients with type 2 diabetes (T2D), increased visit-to-visit variability in glycated hemoglobin (A1c) and fasting plasma glucose (FPG) was associated with a higher risk for severe hypoglycemia; however, FPG variability better predicted severe hypoglycemic events than A1c variability.

 

Major finding: Each standard deviation (SD) increase in the variability in A1c and FPG significantly increased the risk for hypoglycemia requiring any third-party assistance (adjusted hazard ratio [aHR] 1.10 and aHR 1.40, respectively; both P < .01) and hypoglycemia requiring medical assistance (aHR 1.11 and aHR 1.46, respectively; both P < .01). However, FPG variability better predicted severe hypoglycemic events than A1c variability (P < .01).

 

Study details: Findings are from a post hoc analysis of the ACCORD trial including patients with T2D and a high risk for cardiovascular disease, of which 10,052 and 10,068 patients were included in A1c and FPG variability analyses, respectively.

 

Disclosures: This study was partly supported by the National Science Foundation of China project. The authors declared no conflicts of interest.

 

Source: Long C et al. Association of long-term visit-to-visit variability of HbA1c and fasting glycemia with hypoglycemia in type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2022;13:975468 (Aug 11). Doi: 10.3389/fendo.2022.975468

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SGLT2i vs DPP4i tied with reduced mortality and HF readmission risk in T2D patients with HF

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Key clinical point: Sodium-glucose cotransporter-2 inhibitor (SGLT2i) vs dipeptidyl peptidase-4 inhibitor (DPP4i) use at discharge was associated with a lower risk for 1-year all-cause mortality and heart failure (HF) readmission in hospitalized patients with HF and type 2 diabetes (T2D) in a superaged society.

 

Major finding: Overall, 71.91% of patients were 75 years old. SGLT2i vs DPP4i significantly reduced the risk for 1-year all-cause mortality (adjusted hazard ratio [aHR] 0.70; 95% CI 0.56-0.89) and HF readmission (aHRk 0.52; 95% CI 0.45-0.61), with findings being similar among very elderly patients (age, 75 years).

 

Study details: Findings are from a retrospective study including patients hospitalized with the first episode of acute HF and T2D, of which 2101 patients with T2D receiving SGLT2i were propensity score-matched with 2101 of those receiving DPP4i.

 

Disclosures: This work was supported by Labor Research Grants from the Ministry of Health, Labour, and Welfare of Japan. The authors declared no conflicts of interest.

 

Source: Nakai M et al. Contemporary use of SGLT2 inhibitors in heart failure patients with diabetes mellitus: A comparison of DPP4 inhibitors in a nationwide electric health database of the superaged society. Cardiovasc Diabetol. 2022;21:157 (Aug 13). Doi: 10.1186/s12933-022-01586-6

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Key clinical point: Sodium-glucose cotransporter-2 inhibitor (SGLT2i) vs dipeptidyl peptidase-4 inhibitor (DPP4i) use at discharge was associated with a lower risk for 1-year all-cause mortality and heart failure (HF) readmission in hospitalized patients with HF and type 2 diabetes (T2D) in a superaged society.

 

Major finding: Overall, 71.91% of patients were 75 years old. SGLT2i vs DPP4i significantly reduced the risk for 1-year all-cause mortality (adjusted hazard ratio [aHR] 0.70; 95% CI 0.56-0.89) and HF readmission (aHRk 0.52; 95% CI 0.45-0.61), with findings being similar among very elderly patients (age, 75 years).

 

Study details: Findings are from a retrospective study including patients hospitalized with the first episode of acute HF and T2D, of which 2101 patients with T2D receiving SGLT2i were propensity score-matched with 2101 of those receiving DPP4i.

 

Disclosures: This work was supported by Labor Research Grants from the Ministry of Health, Labour, and Welfare of Japan. The authors declared no conflicts of interest.

 

Source: Nakai M et al. Contemporary use of SGLT2 inhibitors in heart failure patients with diabetes mellitus: A comparison of DPP4 inhibitors in a nationwide electric health database of the superaged society. Cardiovasc Diabetol. 2022;21:157 (Aug 13). Doi: 10.1186/s12933-022-01586-6

Key clinical point: Sodium-glucose cotransporter-2 inhibitor (SGLT2i) vs dipeptidyl peptidase-4 inhibitor (DPP4i) use at discharge was associated with a lower risk for 1-year all-cause mortality and heart failure (HF) readmission in hospitalized patients with HF and type 2 diabetes (T2D) in a superaged society.

 

Major finding: Overall, 71.91% of patients were 75 years old. SGLT2i vs DPP4i significantly reduced the risk for 1-year all-cause mortality (adjusted hazard ratio [aHR] 0.70; 95% CI 0.56-0.89) and HF readmission (aHRk 0.52; 95% CI 0.45-0.61), with findings being similar among very elderly patients (age, 75 years).

 

Study details: Findings are from a retrospective study including patients hospitalized with the first episode of acute HF and T2D, of which 2101 patients with T2D receiving SGLT2i were propensity score-matched with 2101 of those receiving DPP4i.

 

Disclosures: This work was supported by Labor Research Grants from the Ministry of Health, Labour, and Welfare of Japan. The authors declared no conflicts of interest.

 

Source: Nakai M et al. Contemporary use of SGLT2 inhibitors in heart failure patients with diabetes mellitus: A comparison of DPP4 inhibitors in a nationwide electric health database of the superaged society. Cardiovasc Diabetol. 2022;21:157 (Aug 13). Doi: 10.1186/s12933-022-01586-6

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Effect of DPP4 inhibitors on glycemic variability in T2D

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Key clinical point: Dipeptidyl peptidase-4 (DPP4) inhibitors were more effective than other oral antidiabetic drugs (OAD) in reducing glycemic variability in patients with type 2 diabetes (T2D) receiving no concurrent insulin treatment.

 

Major finding: The mean amplitude of glycemic excursions reduced significantly in patients receiving DPP4 inhibitors vs other OAD (mean difference [MD] 0.69 mmol/L; P < .001), insulin secretagogues (MD 0.92 mmol/L; P < .001), non-secretagogues (MD 0.43 mmol/L; P = .02), sulfonylureas (MD 0.91 mmol/L; P < .001), and sodium-glucose cotransporter-2 inhibitors (MD 0.67 mmol/L; P = .03).

 

Study details: The data come from a meta-analysis of 14 randomized controlled trials including 855 patients with T2D.

 

Disclosures: This study was funded by MSD China Holding Co. Ltd. Four authors declared being employees of MSD China, and one author declared being an employee of Merck Sharp & Dohme LLC.

 

Source: Chai S et al. Influence of dipeptidyl peptidase-4 inhibitors on glycemic variability in patients with type 2 diabetes: A meta-analysis of randomized controlled trials. Front Endocrinol (Lausanne). 2022;13:935039 (Aug 9). Doi: 10.3389/fendo.2022.935039

 

 

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Key clinical point: Dipeptidyl peptidase-4 (DPP4) inhibitors were more effective than other oral antidiabetic drugs (OAD) in reducing glycemic variability in patients with type 2 diabetes (T2D) receiving no concurrent insulin treatment.

 

Major finding: The mean amplitude of glycemic excursions reduced significantly in patients receiving DPP4 inhibitors vs other OAD (mean difference [MD] 0.69 mmol/L; P < .001), insulin secretagogues (MD 0.92 mmol/L; P < .001), non-secretagogues (MD 0.43 mmol/L; P = .02), sulfonylureas (MD 0.91 mmol/L; P < .001), and sodium-glucose cotransporter-2 inhibitors (MD 0.67 mmol/L; P = .03).

 

Study details: The data come from a meta-analysis of 14 randomized controlled trials including 855 patients with T2D.

 

Disclosures: This study was funded by MSD China Holding Co. Ltd. Four authors declared being employees of MSD China, and one author declared being an employee of Merck Sharp & Dohme LLC.

 

Source: Chai S et al. Influence of dipeptidyl peptidase-4 inhibitors on glycemic variability in patients with type 2 diabetes: A meta-analysis of randomized controlled trials. Front Endocrinol (Lausanne). 2022;13:935039 (Aug 9). Doi: 10.3389/fendo.2022.935039

 

 

Key clinical point: Dipeptidyl peptidase-4 (DPP4) inhibitors were more effective than other oral antidiabetic drugs (OAD) in reducing glycemic variability in patients with type 2 diabetes (T2D) receiving no concurrent insulin treatment.

 

Major finding: The mean amplitude of glycemic excursions reduced significantly in patients receiving DPP4 inhibitors vs other OAD (mean difference [MD] 0.69 mmol/L; P < .001), insulin secretagogues (MD 0.92 mmol/L; P < .001), non-secretagogues (MD 0.43 mmol/L; P = .02), sulfonylureas (MD 0.91 mmol/L; P < .001), and sodium-glucose cotransporter-2 inhibitors (MD 0.67 mmol/L; P = .03).

 

Study details: The data come from a meta-analysis of 14 randomized controlled trials including 855 patients with T2D.

 

Disclosures: This study was funded by MSD China Holding Co. Ltd. Four authors declared being employees of MSD China, and one author declared being an employee of Merck Sharp & Dohme LLC.

 

Source: Chai S et al. Influence of dipeptidyl peptidase-4 inhibitors on glycemic variability in patients with type 2 diabetes: A meta-analysis of randomized controlled trials. Front Endocrinol (Lausanne). 2022;13:935039 (Aug 9). Doi: 10.3389/fendo.2022.935039

 

 

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No effect of SGLT-2 inhibitors on cardiac autonomic neuropathy indices in T2D

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Key clinical point: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors did not have any significant beneficial effects on cardiac autonomic neuropathy (CAN) indices in patients with type 2 diabetes (T2D).

 

Major finding: SGLT-2 inhibitors had no significant effect on the low-frequency-to-high-frequency ratio (mean difference [MD] −0.11; P = .36), change in standard deviation of all 5-minute mean normal RR intervals (MD −2.83; P = .23), and change in the square root of the mean of the sum of the squares of differences between adjacent RR intervals (MD −0.14; P = .94).

 

Study details: Findings are from a meta-analysis of four randomized controlled trials including 247 patients with T2D who were randomly assigned to receive SGLT-2 inhibitors or placebo/active comparator.

 

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

 

Source: Patoulias D et al. Effect of SGLT-2 inhibitors on cardiac autonomic function in type 2 diabetes mellitus: A meta-analysis of randomized controlled trials. Acta Diabetol. 2022 (Aug 19). Doi: 10.1007/s00592-022-01958-0

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Key clinical point: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors did not have any significant beneficial effects on cardiac autonomic neuropathy (CAN) indices in patients with type 2 diabetes (T2D).

 

Major finding: SGLT-2 inhibitors had no significant effect on the low-frequency-to-high-frequency ratio (mean difference [MD] −0.11; P = .36), change in standard deviation of all 5-minute mean normal RR intervals (MD −2.83; P = .23), and change in the square root of the mean of the sum of the squares of differences between adjacent RR intervals (MD −0.14; P = .94).

 

Study details: Findings are from a meta-analysis of four randomized controlled trials including 247 patients with T2D who were randomly assigned to receive SGLT-2 inhibitors or placebo/active comparator.

 

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

 

Source: Patoulias D et al. Effect of SGLT-2 inhibitors on cardiac autonomic function in type 2 diabetes mellitus: A meta-analysis of randomized controlled trials. Acta Diabetol. 2022 (Aug 19). Doi: 10.1007/s00592-022-01958-0

Key clinical point: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors did not have any significant beneficial effects on cardiac autonomic neuropathy (CAN) indices in patients with type 2 diabetes (T2D).

 

Major finding: SGLT-2 inhibitors had no significant effect on the low-frequency-to-high-frequency ratio (mean difference [MD] −0.11; P = .36), change in standard deviation of all 5-minute mean normal RR intervals (MD −2.83; P = .23), and change in the square root of the mean of the sum of the squares of differences between adjacent RR intervals (MD −0.14; P = .94).

 

Study details: Findings are from a meta-analysis of four randomized controlled trials including 247 patients with T2D who were randomly assigned to receive SGLT-2 inhibitors or placebo/active comparator.

 

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

 

Source: Patoulias D et al. Effect of SGLT-2 inhibitors on cardiac autonomic function in type 2 diabetes mellitus: A meta-analysis of randomized controlled trials. Acta Diabetol. 2022 (Aug 19). Doi: 10.1007/s00592-022-01958-0

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Treatment advancement with iGlarLixi as effective as BI+RAI in real world in T2D

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Key clinical point: In patients with type 2 diabetes (T2D) advancing from basal insulin (BI) therapy, a once-daily insulin glargine 100 U/mL and lixisenatide (iGlarLixi) injection regimen showed similar glycemic control to multiple injections with BI plus rapid-acting insulin (RAI), without weight gain.

 

Major finding: At 6 months, the mean reduction in glycated hemoglobin with iGlarLixi was noninferior to BI+RAI (mean difference [MD] 0.1%; 1-sided P = .0032), with weight gain being significantly lower with iGlarLixi vs BI+RAI (MD −0.8 kg; 2-sided P = .0069). The incidence of hypoglycemia was similar between the treatment groups.

 

Study details: Findings are from a retrospective study that used propensity score matching to evaluate therapy advancement with iGlarLixi (n = 814) or BI+RAI (n = 814) in patients with T2D on BI therapy.

 

Disclosures: This study was funded by Sanofi, Paris, France. Some authors declared receiving honoraria for speaking or consulting or research support or serving as advisory board members or speakers for various sources, including Sanofi. Three authors reported being employees of Sanofi.

 

Source: McCrimmon RJ et al. iGlarLixi versus basal plus rapid-acting insulin in adults with type 2 diabetes advancing from basal insulin therapy: The SoliSimplify real-world study. Diabetes Obes Metab. 2022 (Aug 19). Doi: 10.1111/dom.14844

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Key clinical point: In patients with type 2 diabetes (T2D) advancing from basal insulin (BI) therapy, a once-daily insulin glargine 100 U/mL and lixisenatide (iGlarLixi) injection regimen showed similar glycemic control to multiple injections with BI plus rapid-acting insulin (RAI), without weight gain.

 

Major finding: At 6 months, the mean reduction in glycated hemoglobin with iGlarLixi was noninferior to BI+RAI (mean difference [MD] 0.1%; 1-sided P = .0032), with weight gain being significantly lower with iGlarLixi vs BI+RAI (MD −0.8 kg; 2-sided P = .0069). The incidence of hypoglycemia was similar between the treatment groups.

 

Study details: Findings are from a retrospective study that used propensity score matching to evaluate therapy advancement with iGlarLixi (n = 814) or BI+RAI (n = 814) in patients with T2D on BI therapy.

 

Disclosures: This study was funded by Sanofi, Paris, France. Some authors declared receiving honoraria for speaking or consulting or research support or serving as advisory board members or speakers for various sources, including Sanofi. Three authors reported being employees of Sanofi.

 

Source: McCrimmon RJ et al. iGlarLixi versus basal plus rapid-acting insulin in adults with type 2 diabetes advancing from basal insulin therapy: The SoliSimplify real-world study. Diabetes Obes Metab. 2022 (Aug 19). Doi: 10.1111/dom.14844

Key clinical point: In patients with type 2 diabetes (T2D) advancing from basal insulin (BI) therapy, a once-daily insulin glargine 100 U/mL and lixisenatide (iGlarLixi) injection regimen showed similar glycemic control to multiple injections with BI plus rapid-acting insulin (RAI), without weight gain.

 

Major finding: At 6 months, the mean reduction in glycated hemoglobin with iGlarLixi was noninferior to BI+RAI (mean difference [MD] 0.1%; 1-sided P = .0032), with weight gain being significantly lower with iGlarLixi vs BI+RAI (MD −0.8 kg; 2-sided P = .0069). The incidence of hypoglycemia was similar between the treatment groups.

 

Study details: Findings are from a retrospective study that used propensity score matching to evaluate therapy advancement with iGlarLixi (n = 814) or BI+RAI (n = 814) in patients with T2D on BI therapy.

 

Disclosures: This study was funded by Sanofi, Paris, France. Some authors declared receiving honoraria for speaking or consulting or research support or serving as advisory board members or speakers for various sources, including Sanofi. Three authors reported being employees of Sanofi.

 

Source: McCrimmon RJ et al. iGlarLixi versus basal plus rapid-acting insulin in adults with type 2 diabetes advancing from basal insulin therapy: The SoliSimplify real-world study. Diabetes Obes Metab. 2022 (Aug 19). Doi: 10.1111/dom.14844

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Dapagliflozin prevents kidney function decline in T2D

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Key clinical point: Dapagliflozin significantly reduced kidney function decline in patients with type 2 diabetes (T2D) and a high cardiovascular disease (CVD) risk across all Kidney Disease: Improving Global Outcomes (KDIGO) risk categories, including those with low baseline end-stage kidney disease (ESKD) risk

 

Major finding: Dapagliflozin vs placebo led to a significant reduction in kidney-specific composite outcome across all KDIGO risk categories (Pinteraction = .97), including those with low baseline kidney disease risk (hazard ratio 0.54; P < .001), with the risk for estimated glomerular filtration rate (eGFR) reductions by 30%, 40%, 50%, and 57% being significantly lower with dapagliflozin vs placebo (all P < .05).

 

Study details: Findings are from a post hoc analysis of the DECLARE-TIMI 58 trial including 16,842 patients with T2D at high CVD risk and low (n = 10,958), moderate (n = 4243), high (n = 1403), and very high (n = 238) ESKD risk according to KDIGO risk categories.

 

Disclosures: The DECLARE-TIMI 58 trial was funded by AstraZeneca and Bristol-Myers Squibb. Some authors reported receiving research funding, grant support, honoraria, personal fees, or consultancy fees or serving as advisory board members for various resources.

 

Source: Mosenzon O et al. Dapagliflozin and prevention of kidney disease among patients with type 2 diabetes--Post hoc analyses from the DECLARE-TIMI 58 trial. Diabetes Care. 2022 (Aug 23). Doi: 10.2337/dc22-0382

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Key clinical point: Dapagliflozin significantly reduced kidney function decline in patients with type 2 diabetes (T2D) and a high cardiovascular disease (CVD) risk across all Kidney Disease: Improving Global Outcomes (KDIGO) risk categories, including those with low baseline end-stage kidney disease (ESKD) risk

 

Major finding: Dapagliflozin vs placebo led to a significant reduction in kidney-specific composite outcome across all KDIGO risk categories (Pinteraction = .97), including those with low baseline kidney disease risk (hazard ratio 0.54; P < .001), with the risk for estimated glomerular filtration rate (eGFR) reductions by 30%, 40%, 50%, and 57% being significantly lower with dapagliflozin vs placebo (all P < .05).

 

Study details: Findings are from a post hoc analysis of the DECLARE-TIMI 58 trial including 16,842 patients with T2D at high CVD risk and low (n = 10,958), moderate (n = 4243), high (n = 1403), and very high (n = 238) ESKD risk according to KDIGO risk categories.

 

Disclosures: The DECLARE-TIMI 58 trial was funded by AstraZeneca and Bristol-Myers Squibb. Some authors reported receiving research funding, grant support, honoraria, personal fees, or consultancy fees or serving as advisory board members for various resources.

 

Source: Mosenzon O et al. Dapagliflozin and prevention of kidney disease among patients with type 2 diabetes--Post hoc analyses from the DECLARE-TIMI 58 trial. Diabetes Care. 2022 (Aug 23). Doi: 10.2337/dc22-0382

Key clinical point: Dapagliflozin significantly reduced kidney function decline in patients with type 2 diabetes (T2D) and a high cardiovascular disease (CVD) risk across all Kidney Disease: Improving Global Outcomes (KDIGO) risk categories, including those with low baseline end-stage kidney disease (ESKD) risk

 

Major finding: Dapagliflozin vs placebo led to a significant reduction in kidney-specific composite outcome across all KDIGO risk categories (Pinteraction = .97), including those with low baseline kidney disease risk (hazard ratio 0.54; P < .001), with the risk for estimated glomerular filtration rate (eGFR) reductions by 30%, 40%, 50%, and 57% being significantly lower with dapagliflozin vs placebo (all P < .05).

 

Study details: Findings are from a post hoc analysis of the DECLARE-TIMI 58 trial including 16,842 patients with T2D at high CVD risk and low (n = 10,958), moderate (n = 4243), high (n = 1403), and very high (n = 238) ESKD risk according to KDIGO risk categories.

 

Disclosures: The DECLARE-TIMI 58 trial was funded by AstraZeneca and Bristol-Myers Squibb. Some authors reported receiving research funding, grant support, honoraria, personal fees, or consultancy fees or serving as advisory board members for various resources.

 

Source: Mosenzon O et al. Dapagliflozin and prevention of kidney disease among patients with type 2 diabetes--Post hoc analyses from the DECLARE-TIMI 58 trial. Diabetes Care. 2022 (Aug 23). Doi: 10.2337/dc22-0382

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New-onset AF raises the risk for CVD, CKD, and mortality in T2D

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Key clinical point: Patients with type 2 diabetes (T2D) and new-onset atrial fibrillation (AF) are at a higher risk for subsequent atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), chronic kidney disease (CKD), all-cause mortality, and cardiovascular disease (CVD) mortality compared with those with T2D and without new-onset AF.

 

Major finding: Among patients with T2D, those with vs without incident AF had a higher risk for ASCVD (adjusted hazard ratio [aHR] 1.85; 95% CI 1.59-2.16), HF (aHR 4.40; 95% CI 3.67-5.28), CKD (aHR 1.68; 95% CI 1.41-2.01), all-cause mortality (aHR 2.91; 95% CI 2.53-3.34), and CVD mortality (aHR 3.75; 95% CI 2.93-4.80).

 

Study details: This study included 16,551 patients with T2D and without CVD and CKD, of which 1394 developed AF during follow-up.

 

Disclosures: This study did not receive any funding. No potential conflicts of interest were reported.

 

Source: Geng T et al. Associations of new-onset atrial fibrillation with risks of cardiovascular disease, chronic kidney disease, and mortality among patients with type 2 diabetes. Diabetes Care. 2022 (Aug 19). Doi: 10.2337/dc22-0717

 

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Key clinical point: Patients with type 2 diabetes (T2D) and new-onset atrial fibrillation (AF) are at a higher risk for subsequent atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), chronic kidney disease (CKD), all-cause mortality, and cardiovascular disease (CVD) mortality compared with those with T2D and without new-onset AF.

 

Major finding: Among patients with T2D, those with vs without incident AF had a higher risk for ASCVD (adjusted hazard ratio [aHR] 1.85; 95% CI 1.59-2.16), HF (aHR 4.40; 95% CI 3.67-5.28), CKD (aHR 1.68; 95% CI 1.41-2.01), all-cause mortality (aHR 2.91; 95% CI 2.53-3.34), and CVD mortality (aHR 3.75; 95% CI 2.93-4.80).

 

Study details: This study included 16,551 patients with T2D and without CVD and CKD, of which 1394 developed AF during follow-up.

 

Disclosures: This study did not receive any funding. No potential conflicts of interest were reported.

 

Source: Geng T et al. Associations of new-onset atrial fibrillation with risks of cardiovascular disease, chronic kidney disease, and mortality among patients with type 2 diabetes. Diabetes Care. 2022 (Aug 19). Doi: 10.2337/dc22-0717

 

Key clinical point: Patients with type 2 diabetes (T2D) and new-onset atrial fibrillation (AF) are at a higher risk for subsequent atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), chronic kidney disease (CKD), all-cause mortality, and cardiovascular disease (CVD) mortality compared with those with T2D and without new-onset AF.

 

Major finding: Among patients with T2D, those with vs without incident AF had a higher risk for ASCVD (adjusted hazard ratio [aHR] 1.85; 95% CI 1.59-2.16), HF (aHR 4.40; 95% CI 3.67-5.28), CKD (aHR 1.68; 95% CI 1.41-2.01), all-cause mortality (aHR 2.91; 95% CI 2.53-3.34), and CVD mortality (aHR 3.75; 95% CI 2.93-4.80).

 

Study details: This study included 16,551 patients with T2D and without CVD and CKD, of which 1394 developed AF during follow-up.

 

Disclosures: This study did not receive any funding. No potential conflicts of interest were reported.

 

Source: Geng T et al. Associations of new-onset atrial fibrillation with risks of cardiovascular disease, chronic kidney disease, and mortality among patients with type 2 diabetes. Diabetes Care. 2022 (Aug 19). Doi: 10.2337/dc22-0717

 

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Canagliflozin reduces total CV burden in T2D patients with CKD

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Key clinical point: Canagliflozin reduced not only the risk for the first cardiovascular (CV) events but also subsequent CV events in patients with type 2 diabetes and chronic kidney disease (CKD), with absolute benefits being greater for total CV events.

 

Major finding: Canagliflozin reduced the risk for the first (hazard ratio 0.74; P < .001) and total (incidence rate ratio 0.71; P < .001) CV events by 26% and 29%, respectively, with the absolute risk difference per 1000 patients treated over 2.5 years being −44 (95% CI −67 to −21) and −73 (95% CI −114 to −33) for the first and total CV events, respectively.

 

Study details: This was a post hoc analysis of the CREDENCE trial including patients with type 2 diabetes (T2D; glycated hemoglobin 6.5%-12.0%) and CKD who were randomly assigned to receive canagliflozin or placebo.

 

Disclosures: The CREDENCE trial was sponsored by Janssen Research & Development, LLC. Some authors reported serving as advisory board members, speakers, or consultants, or receiving honoraria, research support, consulting, travel, or scientific presentation fees from various sources, including Janssen.

 

Source: Li JW et al. Effect of canagliflozin on total cardiovascular burden in patients with diabetes and chronic kidney disease: A post hoc analysis from the CREDENCE trial. J Am Heart Assoc. 2022;11(16):e025045 (Aug 5). Doi: 10.1161/JAHA.121.025045

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Key clinical point: Canagliflozin reduced not only the risk for the first cardiovascular (CV) events but also subsequent CV events in patients with type 2 diabetes and chronic kidney disease (CKD), with absolute benefits being greater for total CV events.

 

Major finding: Canagliflozin reduced the risk for the first (hazard ratio 0.74; P < .001) and total (incidence rate ratio 0.71; P < .001) CV events by 26% and 29%, respectively, with the absolute risk difference per 1000 patients treated over 2.5 years being −44 (95% CI −67 to −21) and −73 (95% CI −114 to −33) for the first and total CV events, respectively.

 

Study details: This was a post hoc analysis of the CREDENCE trial including patients with type 2 diabetes (T2D; glycated hemoglobin 6.5%-12.0%) and CKD who were randomly assigned to receive canagliflozin or placebo.

 

Disclosures: The CREDENCE trial was sponsored by Janssen Research & Development, LLC. Some authors reported serving as advisory board members, speakers, or consultants, or receiving honoraria, research support, consulting, travel, or scientific presentation fees from various sources, including Janssen.

 

Source: Li JW et al. Effect of canagliflozin on total cardiovascular burden in patients with diabetes and chronic kidney disease: A post hoc analysis from the CREDENCE trial. J Am Heart Assoc. 2022;11(16):e025045 (Aug 5). Doi: 10.1161/JAHA.121.025045

Key clinical point: Canagliflozin reduced not only the risk for the first cardiovascular (CV) events but also subsequent CV events in patients with type 2 diabetes and chronic kidney disease (CKD), with absolute benefits being greater for total CV events.

 

Major finding: Canagliflozin reduced the risk for the first (hazard ratio 0.74; P < .001) and total (incidence rate ratio 0.71; P < .001) CV events by 26% and 29%, respectively, with the absolute risk difference per 1000 patients treated over 2.5 years being −44 (95% CI −67 to −21) and −73 (95% CI −114 to −33) for the first and total CV events, respectively.

 

Study details: This was a post hoc analysis of the CREDENCE trial including patients with type 2 diabetes (T2D; glycated hemoglobin 6.5%-12.0%) and CKD who were randomly assigned to receive canagliflozin or placebo.

 

Disclosures: The CREDENCE trial was sponsored by Janssen Research & Development, LLC. Some authors reported serving as advisory board members, speakers, or consultants, or receiving honoraria, research support, consulting, travel, or scientific presentation fees from various sources, including Janssen.

 

Source: Li JW et al. Effect of canagliflozin on total cardiovascular burden in patients with diabetes and chronic kidney disease: A post hoc analysis from the CREDENCE trial. J Am Heart Assoc. 2022;11(16):e025045 (Aug 5). Doi: 10.1161/JAHA.121.025045

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At EASD, docs to eye new tactics for type 2 diabetes

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Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.

The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.

“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.

What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”  

EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”

This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.  
 

DELIVER: The diabetes side

On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.

Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.

“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”

“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”

Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”

However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
 

Tirzepatide, weight loss, and type 2 diabetes remission

On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.

Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.

At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”

Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.

“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”

Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.

“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.  

The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.  

The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”

Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
 

COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more

As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.

Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.

Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.

On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”

And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.

Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.

“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”

Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.

A version of this article first appeared on Medscape.com.  
 

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Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.

The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.

“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.

What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”  

EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”

This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.  
 

DELIVER: The diabetes side

On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.

Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.

“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”

“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”

Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”

However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
 

Tirzepatide, weight loss, and type 2 diabetes remission

On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.

Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.

At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”

Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.

“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”

Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.

“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.  

The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.  

The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”

Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
 

COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more

As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.

Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.

Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.

On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”

And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.

Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.

“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”

Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.

A version of this article first appeared on Medscape.com.  
 

Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.

The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.

“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.

What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”  

EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”

This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.  
 

DELIVER: The diabetes side

On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.

Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.

“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”

“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”

Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”

However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
 

Tirzepatide, weight loss, and type 2 diabetes remission

On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.

Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.

At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”

Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.

“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”

Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.

“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.  

The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.  

The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”

Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
 

COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more

As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.

Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.

Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.

On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”

And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.

Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.

“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”

Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.

A version of this article first appeared on Medscape.com.  
 

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Diabetes Population Health Innovations in the Age of COVID-19: Insights From the T1D Exchange Quality Improvement Collaborative

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Diabetes Population Health Innovations in the Age of COVID-19: Insights From the T1D Exchange Quality Improvement Collaborative

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.1 Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.2 The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Geographical distribution of T1DX-QI Centers before and during the COVID-19 pandemic

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.7 T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.8

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

 

 

Methods

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Diabetes population health innovations

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,15 including those with complex cases.16 Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).17 Additional studies, like those conducted by Phillip et al,18 confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.19

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.31 In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.32 The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.33

Health Equity

While inequities across various health outcomes have been well documented for years,34 the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).36 One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.37 There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.38 A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.39 The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.40

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).41 Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

New Diabetes Technologies 2020-2022

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.42 This effort has been expanded and will continue in 2022 and beyond,43 and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.44

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.48 These systems support reduced hypoglycemia and improved time in range.49

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs50,51 and even a patch to deliver insulin without the burden of injections.52 As barriers to diabetes technology persist,53 innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.56 Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.57 Other recent advances include stem cell replacement therapy for patients with T1D.58 The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.59

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.62 Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,63 advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,64 and 20 states passed legislation capping insulin pricing.62 Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.65

 

 

Perspective: The Role of Private Philanthropy in Supporting Population Health Innovations

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.66 Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.67

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: [email protected]

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

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40. Ebekozien O, Mungmode A, Buckingham D, et al. Achieving equity in diabetes research: borrowing from the field of quality improvement using a practical framework and improvement tools. Diabetes Spectr. 2022;35(3):304-312. doi:10.2237/dsi22-0002

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64. Brown TD. How Medicare’s new Senior Savings Model makes insulin more affordable. June 4, 2020. Accessed August 30, 2022. https://www.diabetes.org/blog/how-medicares-new-senior-savings-model-makes-insulin-more-affordable

65. American Diabetes Association. ADA applauds the U.S. House of Representatives passage of the Affordable Insulin Now Act. News release. April 1, 2022. https://www.diabetes.org/newsroom/official-statement/2022/ada-applauds-us-house-of-representatives-passage-of-the-affordable-insulin-now-act

66. JDRF. Driving T1D cures during challenging times. 2022.

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From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.1 Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.2 The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Geographical distribution of T1DX-QI Centers before and during the COVID-19 pandemic

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.7 T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.8

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

 

 

Methods

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Diabetes population health innovations

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,15 including those with complex cases.16 Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).17 Additional studies, like those conducted by Phillip et al,18 confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.19

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.31 In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.32 The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.33

Health Equity

While inequities across various health outcomes have been well documented for years,34 the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).36 One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.37 There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.38 A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.39 The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.40

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).41 Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

New Diabetes Technologies 2020-2022

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.42 This effort has been expanded and will continue in 2022 and beyond,43 and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.44

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.48 These systems support reduced hypoglycemia and improved time in range.49

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs50,51 and even a patch to deliver insulin without the burden of injections.52 As barriers to diabetes technology persist,53 innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.56 Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.57 Other recent advances include stem cell replacement therapy for patients with T1D.58 The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.59

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.62 Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,63 advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,64 and 20 states passed legislation capping insulin pricing.62 Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.65

 

 

Perspective: The Role of Private Philanthropy in Supporting Population Health Innovations

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.66 Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.67

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: [email protected]

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.1 Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.2 The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Geographical distribution of T1DX-QI Centers before and during the COVID-19 pandemic

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.7 T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.8

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

 

 

Methods

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Diabetes population health innovations

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,15 including those with complex cases.16 Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).17 Additional studies, like those conducted by Phillip et al,18 confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.19

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.31 In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.32 The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.33

Health Equity

While inequities across various health outcomes have been well documented for years,34 the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).36 One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.37 There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.38 A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.39 The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.40

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).41 Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

New Diabetes Technologies 2020-2022

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.42 This effort has been expanded and will continue in 2022 and beyond,43 and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.44

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.48 These systems support reduced hypoglycemia and improved time in range.49

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs50,51 and even a patch to deliver insulin without the burden of injections.52 As barriers to diabetes technology persist,53 innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.56 Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.57 Other recent advances include stem cell replacement therapy for patients with T1D.58 The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.59

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.62 Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,63 advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,64 and 20 states passed legislation capping insulin pricing.62 Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.65

 

 

Perspective: The Role of Private Philanthropy in Supporting Population Health Innovations

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.66 Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.67

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: [email protected]

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

References

1. Centers for Disease Control and Prevention. National diabetes statistics report. Accessed August 30, 2022. www.cdc.gov/diabetes/data/statistics-report/index.html

2. Centers for Disease Control and Prevention. Diabetes fast facts. Accessed August 30, 2022. www.cdc.gov/diabetes/basics/quick-facts.html

3. O’Malley G, Ebekozien O, Desimone M, et al. COVID-19 hospitalization in adults with type 1 diabetes: results from the T1D Exchange Multicenter Surveillance Study. J Clin Endocrinol Metab. 2020;106(2):e936-e942. doi:10.1210/clinem/dgaa825

4. Ebekozien OA, Noor N, Gallagher MP, Alonso GT. Type 1 diabetes and COVID-19: preliminary findings from a multicenter surveillance study in the U.S. Diabetes Care. 2020;43(8):e83-e85. doi:10.2337/dc20-1088

5. Zimmerman C, Albanese-O’Neill A, Haller MJ. Advances in type 1 diabetes technology over the last decade. Eur Endocrinol. 2019;15(2):70-76. doi:10.17925/ee.2019.15.2.70

6. Wake DJ, Gibb FW, Kar P, et al. Endocrinology in the time of COVID-19: remodelling diabetes services and emerging innovation. Eur J Endocrinol. 2020;183(2):G67-G77. doi:10.1530/eje-20-0377

7. Alonso GT, Corathers S, Shah A, et al. Establishment of the T1D Exchange Quality Improvement Collaborative (T1DX-QI). Clin Diabetes. 2020;38(2):141-151. doi:10.2337/cd19-0032

8. Ginnard OZB, Alonso GT, Corathers SD, et al. Quality improvement in diabetes care: a review of initiatives and outcomes in the T1D Exchange Quality Improvement Collaborative. Clin Diabetes. 2021;39(3):256-263. doi:10.2337/cd21-0029

9. ATTD 2021 invited speaker abstracts. Diabetes Technol Ther. 2021;23(S2):A1-A206. doi:10.1089/dia.2021.2525.abstracts

10. Rompicherla SN, Edelen N, Gallagher R, et al. Children and adolescent patients with pre-existing type 1 diabetes and additional comorbidities have an increased risk of hospitalization from COVID-19; data from the T1D Exchange COVID Registry. Pediatr Diabetes. 2021;22(S30):3-32. doi:10.1111/pedi.13268

11. Abstracts for the T1D Exchange QI Collaborative (T1DX-QI) Learning Session 2021. November 8-9, 2021. J Diabetes. 2021;13(S1):3-17. doi:10.1111/1753-0407.13227

12. The Official Journal of ATTD Advanced Technologies & Treatments for Diabetes conference 27-30 April 2022. Barcelona and online. Diabetes Technol Ther. 2022;24(S1):A1-A237. doi:10.1089/dia.2022.2525.abstracts

13. Ebekozien ON, Kamboj N, Odugbesan MK, et al. Inequities in glycemic outcomes for patients with type 1 diabetes: six-year (2016-2021) longitudinal follow-up by race and ethnicity of 36,390 patients in the T1DX-QI Collaborative. Diabetes. 2022;71(suppl 1). doi:10.2337/db22-167-OR

14. Narayan KA, Noor M, Rompicherla N, et al. No BMI increase during the COVID-pandemic in children and adults with T1D in three continents: joint analysis of ADDN, T1DX, and DPV registries. Diabetes. 2022;71(suppl 1). doi:10.2337/db22-269-OR

15. Lee JY, Lee SWH. Telemedicine cost-effectiveness for diabetes management: a systematic review. Diabetes Technol Ther. 2018;20(7):492-500. doi:10.1089/dia.2018.0098

16. McDonnell ME. Telemedicine in complex diabetes management. Curr Diab Rep. 2018;18(7):42. doi:10.1007/s11892-018-1015-3

17. Lee JM, Carlson E, Albanese-O’Neill A, et al. Adoption of telemedicine for type 1 diabetes care during the COVID-19 pandemic. Diabetes Technol Ther. 2021;23(9):642-651. doi:10.1089/dia.2021.0080

18. Phillip M, Bergenstal RM, Close KL, et al. The digital/virtual diabetes clinic: the future is now–recommendations from an international panel on diabetes digital technologies introduction. Diabetes Technol Ther. 2021;23(2):146-154. doi:10.1089/dia.2020.0375

19. Garg SK, Rodriguez E. COVID‐19 pandemic and diabetes care. Diabetes Technol Ther. 2022;24(S1):S2-S20. doi:10.1089/dia.2022.2501

20. Beliard K, Ebekozien O, Demeterco-Berggren C, et al. Increased DKA at presentation among newly diagnosed type 1 diabetes patients with or without COVID-19: data from a multi-site surveillance registry. J Diabetes. 2021;13(3):270-272. doi:10.1111/1753-0407.13141

21. Ebekozien O, Agarwal S, Noor N, et al. Inequities in diabetic ketoacidosis among patients with type 1 diabetes and COVID-19: data from 52 US clinical centers. J Clin Endocrinol Metab. 2020;106(4):1755-1762. doi:10.1210/clinem/dgaa920

22. Alonso GT, Ebekozien O, Gallagher MP, et al. Diabetic ketoacidosis drives COVID-19 related hospitalizations in children with type 1 diabetes. J Diabetes. 2021;13(8):681-687. doi:10.1111/1753-0407.13184

23. Noor N, Ebekozien O, Levin L, et al. Diabetes technology use for management of type 1 diabetes is associated with fewer adverse COVID-19 outcomes: findings from the T1D Exchange COVID-19 Surveillance Registry. Diabetes Care. 2021;44(8):e160-e162. doi:10.2337/dc21-0074

24. Demeterco-Berggren C, Ebekozien O, Rompicherla S, et al. Age and hospitalization risk in people with type 1 diabetes and COVID-19: data from the T1D Exchange Surveillance Study. J Clin Endocrinol Metab. 2021;107(2):410-418. doi:10.1210/clinem/dgab668

25. DeSalvo DJ, Noor N, Xie C, et al. Patient demographics and clinical outcomes among type 1 diabetes patients using continuous glucose monitors: data from T1D Exchange real-world observational study. J Diabetes Sci Technol. 2021 Oct 9. [Epub ahead of print] doi:10.1177/19322968211049783

26. Gallagher MP, Rompicherla S, Ebekozien O, et al. Differences in COVID-19 outcomes among patients with type 1 diabetes: first vs later surges. J Clin Outcomes Manage. 2022;29(1):27-31. doi:10.12788/jcom.0084

27. Wolf RM, Noor N, Izquierdo R, et al. Increase in newly diagnosed type 1 diabetes in youth during the COVID-19 pandemic in the United States: a multi-center analysis. Pediatr Diabetes. 2022;23(4):433-438. doi:10.1111/pedi.13328

28. Lavik AR, Ebekozien O, Noor N, et al. Trends in type 1 diabetic ketoacidosis during COVID-19 surges at 7 US centers: highest burden on non-Hispanic Black patients. J Clin Endocrinol Metab. 2022;107(7):1948-1955. doi:10.1210/clinem/dgac158

29. van der Linden J, Welsh JB, Hirsch IB, Garg SK. Real-time continuous glucose monitoring during the coronavirus disease 2019 pandemic and its impact on time in range. Diabetes Technol Ther. 2021;23(S1):S1-S7. doi:10.1089/dia.2020.0649

30. Nwosu BU, Al-Halbouni L, Parajuli S, et al. COVID-19 pandemic and pediatric type 1 diabetes: no significant change in glycemic control during the pandemic lockdown of 2020. Front Endocrinol (Lausanne). 2021;12:703905. doi:10.3389/fendo.2021.703905

31. Ellahham S. Artificial intelligence: the future for diabetes care. Am J Med. 2020;133(8):895-900. doi:10.1016/j.amjmed.2020.03.033

32. Nomura A, Noguchi M, Kometani M, et al. Artificial intelligence in current diabetes management and prediction. Curr Diab Rep. 2021;21(12):61. doi:10.1007/s11892-021-01423-2

33. Mungmode A, Noor N, Weinstock RS, et al. Making diabetes electronic medical record data actionable: promoting benchmarking and population health using the T1D Exchange Quality Improvement Portal. Clin Diabetes. Forthcoming 2022.

34. Lavizzo-Mourey RJ, Besser RE, Williams DR. Understanding and mitigating health inequities—past, current, and future directions. N Engl J Med. 2021;384(18):1681-1684. doi:10.1056/NEJMp2008628

35. Majidi S, Ebekozien O, Noor N, et al. Inequities in health outcomes in children and adults with type 1 diabetes: data from the T1D Exchange Quality Improvement Collaborative. Clin Diabetes. 2021;39(3):278-283. doi:10.2337/cd21-0028

36. Ebekozien O, Mungmode A, Odugbesan O, et al. Addressing type 1 diabetes health inequities in the United States: approaches from the T1D Exchange QI Collaborative. J Diabetes. 2022;14(1):79-82. doi:10.1111/1753-0407.13235

37. Odugbesan O, Addala A, Nelson G, et al. Implicit racial-ethnic and insurance-mediated bias to recommending diabetes technology: insights from T1D Exchange multicenter pediatric and adult diabetes provider cohort. Diabetes Technol Ther. 2022 Jun 13. [Epub ahead of print] doi:10.1089/dia.2022.0042

38. Schmitt J, Fogle K, Scott ML, Iyer P. Improving equitable access to continuous glucose monitors for Alabama’s children with type 1 diabetes: a quality improvement project. Diabetes Technol Ther. 2022;24(7):481-491. doi:10.1089/dia.2021.0511

39. Akturk HK, Agarwal S, Hoffecker L, Shah VN. Inequity in racial-ethnic representation in randomized controlled trials of diabetes technologies in type 1 diabetes: critical need for new standards. Diabetes Care. 2021;44(6):e121-e123. doi:10.2337/dc20-3063

40. Ebekozien O, Mungmode A, Buckingham D, et al. Achieving equity in diabetes research: borrowing from the field of quality improvement using a practical framework and improvement tools. Diabetes Spectr. 2022;35(3):304-312. doi:10.2237/dsi22-0002

41. Zhang J, Xu J, Lim J, et al. Wearable glucose monitoring and implantable drug delivery systems for diabetes management. Adv Healthc Mater. 2021;10(17):e2100194. doi:10.1002/adhm.202100194

42. FDA expands remote patient monitoring in hospitals for people with diabetes during COVID-19; manufacturers donate CGM supplies. News release. April 21, 2020. Accessed August 30, 2022. https://www.diabetes.org/newsroom/press-releases/2020/fda-remote-patient-monitoring-cgm

43. Campbell P. FDA grants Dexcom CGM breakthrough designation for in-hospital use. March 2, 2022. Accessed August 30, 2022. https://www.endocrinologynetwork.com/view/fda-grants-dexcom-cgm-breakthrough-designation-for-in-hospital-use

44. Yeh T, Yeung M, Mendelsohn Curanaj FA. Managing patients with insulin pumps and continuous glucose monitors in the hospital: to wear or not to wear. Curr Diab Rep. 2021;21(2):7. doi:10.1007/s11892-021-01375-7

45. Medtronic announces FDA approval for MiniMed 770G insulin pump system. News release. September 21, 2020. Accessed August 30, 2022. https://bit.ly/3TyEna4

46. Tandem Diabetes Care announces commercial launch of the t:slim X2 insulin pump with Control-IQ technology in the United States. News release. January 15, 2020. Accessed August 30, 2022. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-commercial-launch-tslim-x2-0

47. Garza M, Gutow H, Mahoney K. Omnipod 5 cleared by the FDA. Updated August 22, 2022. Accessed August 30, 2022.https://diatribe.org/omnipod-5-approved-fda

48. Boughton CK. Fully closed-loop insulin delivery—are we nearly there yet? Lancet Digit Health. 2021;3(11):e689-e690. doi:10.1016/s2589-7500(21)00218-1

49. Noor N, Kamboj MK, Triolo T, et al. Hybrid closed-loop systems and glycemic outcomes in children and adults with type 1 diabetes: real-world evidence from a U.S.-based multicenter collaborative. Diabetes Care. 2022;45(8):e118-e119. doi:10.2337/dc22-0329

50. Medtronic launches InPen with real-time Guardian Connect CGM data--the first integrated smart insulin pen for people with diabetes on MDI. News release. November 12, 2020. Accessed August 30, 2022. https://bit.ly/3CTSWPL

51. Bigfoot Biomedical receives FDA clearance for Bigfoot Unity Diabetes Management System, featuring first-of-its-kind smart pen caps for insulin pens used to treat type 1 and type 2 diabetes. News release. May 10, 2021. Accessed August 30, 2022. https://bit.ly/3BeyoAh

52. Vieira G. All about the CeQur Simplicity insulin patch. Updated May 24, 2022. Accessed August 30, 2022. https://beyondtype1.org/cequr-simplicity-insulin-patch/.

53. Messer LH, Tanenbaum ML, Cook PF, et al. Cost, hassle, and on-body experience: barriers to diabetes device use in adolescents and potential intervention targets. Diabetes Technol Ther. 2020;22(10):760-767. doi:10.1089/dia.2019.0509

54. Hilliard ME, Levy W, Anderson BJ, et al. Benefits and barriers of continuous glucose monitoring in young children with type 1 diabetes. Diabetes Technol Ther. 2019;21(9):493-498. doi:10.1089/dia.2019.0142

55. Dexcom G7 Release Delayed Until Late 2022. News release. August 8, 2022. Accessed September 7, 2022. https://diatribe.org/dexcom-g7-release-delayed-until-late-2022

56. Drucker DJ. Transforming type 1 diabetes: the next wave of innovation. Diabetologia. 2021;64(5):1059-1065. doi:10.1007/s00125-021-05396-5

57. Garg SK, Rodriguez E, Shah VN, Hirsch IB. New medications for the treatment of diabetes. Diabetes Technol Ther. 2022;24(S1):S190-S208. doi:10.1089/dia.2022.2513

58. Melton D. The promise of stem cell-derived islet replacement therapy. Diabetologia. 2021;64(5):1030-1036. doi:10.1007/s00125-020-05367-2

59. Danne T, Heinemann L, Bolinder J. New insulins, biosimilars, and insulin therapy. Diabetes Technol Ther. 2022;24(S1):S35-S57. doi:10.1089/dia.2022.2503

60. Kenney J. Insulin copay caps–a path to affordability. July 6, 2021. Accessed August 30, 2022.https://diatribechange.org/news/insulin-copay-caps-path-affordability

61. Glied SA, Zhu B. Not so sweet: insulin affordability over time. September 25, 2020. Accessed August 30, 2022. https://www.commonwealthfund.org/publications/issue-briefs/2020/sep/not-so-sweet-insulin-affordability-over-time

62. American Diabetes Association. Insulin and drug affordability. Accessed August 30, 2022. https://www.diabetes.org/advocacy/insulin-and-drug-affordability

63. Sullivan P. Chances for drug pricing, surprise billing action fade until November. March 24, 2020. Accessed August 30, 2022. https://thehill.com/policy/healthcare/489334-chances-for-drug-pricing-surprise-billing-action-fade-until-november/

64. Brown TD. How Medicare’s new Senior Savings Model makes insulin more affordable. June 4, 2020. Accessed August 30, 2022. https://www.diabetes.org/blog/how-medicares-new-senior-savings-model-makes-insulin-more-affordable

65. American Diabetes Association. ADA applauds the U.S. House of Representatives passage of the Affordable Insulin Now Act. News release. April 1, 2022. https://www.diabetes.org/newsroom/official-statement/2022/ada-applauds-us-house-of-representatives-passage-of-the-affordable-insulin-now-act

66. JDRF. Driving T1D cures during challenging times. 2022.

67. Medtronic announces ongoing initiatives to address health equity for people of color living with diabetes. News release. April 7, 2021. Access August 30, 2022. https://bit.ly/3KGTOZU

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2. Centers for Disease Control and Prevention. Diabetes fast facts. Accessed August 30, 2022. www.cdc.gov/diabetes/basics/quick-facts.html

3. O’Malley G, Ebekozien O, Desimone M, et al. COVID-19 hospitalization in adults with type 1 diabetes: results from the T1D Exchange Multicenter Surveillance Study. J Clin Endocrinol Metab. 2020;106(2):e936-e942. doi:10.1210/clinem/dgaa825

4. Ebekozien OA, Noor N, Gallagher MP, Alonso GT. Type 1 diabetes and COVID-19: preliminary findings from a multicenter surveillance study in the U.S. Diabetes Care. 2020;43(8):e83-e85. doi:10.2337/dc20-1088

5. Zimmerman C, Albanese-O’Neill A, Haller MJ. Advances in type 1 diabetes technology over the last decade. Eur Endocrinol. 2019;15(2):70-76. doi:10.17925/ee.2019.15.2.70

6. Wake DJ, Gibb FW, Kar P, et al. Endocrinology in the time of COVID-19: remodelling diabetes services and emerging innovation. Eur J Endocrinol. 2020;183(2):G67-G77. doi:10.1530/eje-20-0377

7. Alonso GT, Corathers S, Shah A, et al. Establishment of the T1D Exchange Quality Improvement Collaborative (T1DX-QI). Clin Diabetes. 2020;38(2):141-151. doi:10.2337/cd19-0032

8. Ginnard OZB, Alonso GT, Corathers SD, et al. Quality improvement in diabetes care: a review of initiatives and outcomes in the T1D Exchange Quality Improvement Collaborative. Clin Diabetes. 2021;39(3):256-263. doi:10.2337/cd21-0029

9. ATTD 2021 invited speaker abstracts. Diabetes Technol Ther. 2021;23(S2):A1-A206. doi:10.1089/dia.2021.2525.abstracts

10. Rompicherla SN, Edelen N, Gallagher R, et al. Children and adolescent patients with pre-existing type 1 diabetes and additional comorbidities have an increased risk of hospitalization from COVID-19; data from the T1D Exchange COVID Registry. Pediatr Diabetes. 2021;22(S30):3-32. doi:10.1111/pedi.13268

11. Abstracts for the T1D Exchange QI Collaborative (T1DX-QI) Learning Session 2021. November 8-9, 2021. J Diabetes. 2021;13(S1):3-17. doi:10.1111/1753-0407.13227

12. The Official Journal of ATTD Advanced Technologies & Treatments for Diabetes conference 27-30 April 2022. Barcelona and online. Diabetes Technol Ther. 2022;24(S1):A1-A237. doi:10.1089/dia.2022.2525.abstracts

13. Ebekozien ON, Kamboj N, Odugbesan MK, et al. Inequities in glycemic outcomes for patients with type 1 diabetes: six-year (2016-2021) longitudinal follow-up by race and ethnicity of 36,390 patients in the T1DX-QI Collaborative. Diabetes. 2022;71(suppl 1). doi:10.2337/db22-167-OR

14. Narayan KA, Noor M, Rompicherla N, et al. No BMI increase during the COVID-pandemic in children and adults with T1D in three continents: joint analysis of ADDN, T1DX, and DPV registries. Diabetes. 2022;71(suppl 1). doi:10.2337/db22-269-OR

15. Lee JY, Lee SWH. Telemedicine cost-effectiveness for diabetes management: a systematic review. Diabetes Technol Ther. 2018;20(7):492-500. doi:10.1089/dia.2018.0098

16. McDonnell ME. Telemedicine in complex diabetes management. Curr Diab Rep. 2018;18(7):42. doi:10.1007/s11892-018-1015-3

17. Lee JM, Carlson E, Albanese-O’Neill A, et al. Adoption of telemedicine for type 1 diabetes care during the COVID-19 pandemic. Diabetes Technol Ther. 2021;23(9):642-651. doi:10.1089/dia.2021.0080

18. Phillip M, Bergenstal RM, Close KL, et al. The digital/virtual diabetes clinic: the future is now–recommendations from an international panel on diabetes digital technologies introduction. Diabetes Technol Ther. 2021;23(2):146-154. doi:10.1089/dia.2020.0375

19. Garg SK, Rodriguez E. COVID‐19 pandemic and diabetes care. Diabetes Technol Ther. 2022;24(S1):S2-S20. doi:10.1089/dia.2022.2501

20. Beliard K, Ebekozien O, Demeterco-Berggren C, et al. Increased DKA at presentation among newly diagnosed type 1 diabetes patients with or without COVID-19: data from a multi-site surveillance registry. J Diabetes. 2021;13(3):270-272. doi:10.1111/1753-0407.13141

21. Ebekozien O, Agarwal S, Noor N, et al. Inequities in diabetic ketoacidosis among patients with type 1 diabetes and COVID-19: data from 52 US clinical centers. J Clin Endocrinol Metab. 2020;106(4):1755-1762. doi:10.1210/clinem/dgaa920

22. Alonso GT, Ebekozien O, Gallagher MP, et al. Diabetic ketoacidosis drives COVID-19 related hospitalizations in children with type 1 diabetes. J Diabetes. 2021;13(8):681-687. doi:10.1111/1753-0407.13184

23. Noor N, Ebekozien O, Levin L, et al. Diabetes technology use for management of type 1 diabetes is associated with fewer adverse COVID-19 outcomes: findings from the T1D Exchange COVID-19 Surveillance Registry. Diabetes Care. 2021;44(8):e160-e162. doi:10.2337/dc21-0074

24. Demeterco-Berggren C, Ebekozien O, Rompicherla S, et al. Age and hospitalization risk in people with type 1 diabetes and COVID-19: data from the T1D Exchange Surveillance Study. J Clin Endocrinol Metab. 2021;107(2):410-418. doi:10.1210/clinem/dgab668

25. DeSalvo DJ, Noor N, Xie C, et al. Patient demographics and clinical outcomes among type 1 diabetes patients using continuous glucose monitors: data from T1D Exchange real-world observational study. J Diabetes Sci Technol. 2021 Oct 9. [Epub ahead of print] doi:10.1177/19322968211049783

26. Gallagher MP, Rompicherla S, Ebekozien O, et al. Differences in COVID-19 outcomes among patients with type 1 diabetes: first vs later surges. J Clin Outcomes Manage. 2022;29(1):27-31. doi:10.12788/jcom.0084

27. Wolf RM, Noor N, Izquierdo R, et al. Increase in newly diagnosed type 1 diabetes in youth during the COVID-19 pandemic in the United States: a multi-center analysis. Pediatr Diabetes. 2022;23(4):433-438. doi:10.1111/pedi.13328

28. Lavik AR, Ebekozien O, Noor N, et al. Trends in type 1 diabetic ketoacidosis during COVID-19 surges at 7 US centers: highest burden on non-Hispanic Black patients. J Clin Endocrinol Metab. 2022;107(7):1948-1955. doi:10.1210/clinem/dgac158

29. van der Linden J, Welsh JB, Hirsch IB, Garg SK. Real-time continuous glucose monitoring during the coronavirus disease 2019 pandemic and its impact on time in range. Diabetes Technol Ther. 2021;23(S1):S1-S7. doi:10.1089/dia.2020.0649

30. Nwosu BU, Al-Halbouni L, Parajuli S, et al. COVID-19 pandemic and pediatric type 1 diabetes: no significant change in glycemic control during the pandemic lockdown of 2020. Front Endocrinol (Lausanne). 2021;12:703905. doi:10.3389/fendo.2021.703905

31. Ellahham S. Artificial intelligence: the future for diabetes care. Am J Med. 2020;133(8):895-900. doi:10.1016/j.amjmed.2020.03.033

32. Nomura A, Noguchi M, Kometani M, et al. Artificial intelligence in current diabetes management and prediction. Curr Diab Rep. 2021;21(12):61. doi:10.1007/s11892-021-01423-2

33. Mungmode A, Noor N, Weinstock RS, et al. Making diabetes electronic medical record data actionable: promoting benchmarking and population health using the T1D Exchange Quality Improvement Portal. Clin Diabetes. Forthcoming 2022.

34. Lavizzo-Mourey RJ, Besser RE, Williams DR. Understanding and mitigating health inequities—past, current, and future directions. N Engl J Med. 2021;384(18):1681-1684. doi:10.1056/NEJMp2008628

35. Majidi S, Ebekozien O, Noor N, et al. Inequities in health outcomes in children and adults with type 1 diabetes: data from the T1D Exchange Quality Improvement Collaborative. Clin Diabetes. 2021;39(3):278-283. doi:10.2337/cd21-0028

36. Ebekozien O, Mungmode A, Odugbesan O, et al. Addressing type 1 diabetes health inequities in the United States: approaches from the T1D Exchange QI Collaborative. J Diabetes. 2022;14(1):79-82. doi:10.1111/1753-0407.13235

37. Odugbesan O, Addala A, Nelson G, et al. Implicit racial-ethnic and insurance-mediated bias to recommending diabetes technology: insights from T1D Exchange multicenter pediatric and adult diabetes provider cohort. Diabetes Technol Ther. 2022 Jun 13. [Epub ahead of print] doi:10.1089/dia.2022.0042

38. Schmitt J, Fogle K, Scott ML, Iyer P. Improving equitable access to continuous glucose monitors for Alabama’s children with type 1 diabetes: a quality improvement project. Diabetes Technol Ther. 2022;24(7):481-491. doi:10.1089/dia.2021.0511

39. Akturk HK, Agarwal S, Hoffecker L, Shah VN. Inequity in racial-ethnic representation in randomized controlled trials of diabetes technologies in type 1 diabetes: critical need for new standards. Diabetes Care. 2021;44(6):e121-e123. doi:10.2337/dc20-3063

40. Ebekozien O, Mungmode A, Buckingham D, et al. Achieving equity in diabetes research: borrowing from the field of quality improvement using a practical framework and improvement tools. Diabetes Spectr. 2022;35(3):304-312. doi:10.2237/dsi22-0002

41. Zhang J, Xu J, Lim J, et al. Wearable glucose monitoring and implantable drug delivery systems for diabetes management. Adv Healthc Mater. 2021;10(17):e2100194. doi:10.1002/adhm.202100194

42. FDA expands remote patient monitoring in hospitals for people with diabetes during COVID-19; manufacturers donate CGM supplies. News release. April 21, 2020. Accessed August 30, 2022. https://www.diabetes.org/newsroom/press-releases/2020/fda-remote-patient-monitoring-cgm

43. Campbell P. FDA grants Dexcom CGM breakthrough designation for in-hospital use. March 2, 2022. Accessed August 30, 2022. https://www.endocrinologynetwork.com/view/fda-grants-dexcom-cgm-breakthrough-designation-for-in-hospital-use

44. Yeh T, Yeung M, Mendelsohn Curanaj FA. Managing patients with insulin pumps and continuous glucose monitors in the hospital: to wear or not to wear. Curr Diab Rep. 2021;21(2):7. doi:10.1007/s11892-021-01375-7

45. Medtronic announces FDA approval for MiniMed 770G insulin pump system. News release. September 21, 2020. Accessed August 30, 2022. https://bit.ly/3TyEna4

46. Tandem Diabetes Care announces commercial launch of the t:slim X2 insulin pump with Control-IQ technology in the United States. News release. January 15, 2020. Accessed August 30, 2022. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-commercial-launch-tslim-x2-0

47. Garza M, Gutow H, Mahoney K. Omnipod 5 cleared by the FDA. Updated August 22, 2022. Accessed August 30, 2022.https://diatribe.org/omnipod-5-approved-fda

48. Boughton CK. Fully closed-loop insulin delivery—are we nearly there yet? Lancet Digit Health. 2021;3(11):e689-e690. doi:10.1016/s2589-7500(21)00218-1

49. Noor N, Kamboj MK, Triolo T, et al. Hybrid closed-loop systems and glycemic outcomes in children and adults with type 1 diabetes: real-world evidence from a U.S.-based multicenter collaborative. Diabetes Care. 2022;45(8):e118-e119. doi:10.2337/dc22-0329

50. Medtronic launches InPen with real-time Guardian Connect CGM data--the first integrated smart insulin pen for people with diabetes on MDI. News release. November 12, 2020. Accessed August 30, 2022. https://bit.ly/3CTSWPL

51. Bigfoot Biomedical receives FDA clearance for Bigfoot Unity Diabetes Management System, featuring first-of-its-kind smart pen caps for insulin pens used to treat type 1 and type 2 diabetes. News release. May 10, 2021. Accessed August 30, 2022. https://bit.ly/3BeyoAh

52. Vieira G. All about the CeQur Simplicity insulin patch. Updated May 24, 2022. Accessed August 30, 2022. https://beyondtype1.org/cequr-simplicity-insulin-patch/.

53. Messer LH, Tanenbaum ML, Cook PF, et al. Cost, hassle, and on-body experience: barriers to diabetes device use in adolescents and potential intervention targets. Diabetes Technol Ther. 2020;22(10):760-767. doi:10.1089/dia.2019.0509

54. Hilliard ME, Levy W, Anderson BJ, et al. Benefits and barriers of continuous glucose monitoring in young children with type 1 diabetes. Diabetes Technol Ther. 2019;21(9):493-498. doi:10.1089/dia.2019.0142

55. Dexcom G7 Release Delayed Until Late 2022. News release. August 8, 2022. Accessed September 7, 2022. https://diatribe.org/dexcom-g7-release-delayed-until-late-2022

56. Drucker DJ. Transforming type 1 diabetes: the next wave of innovation. Diabetologia. 2021;64(5):1059-1065. doi:10.1007/s00125-021-05396-5

57. Garg SK, Rodriguez E, Shah VN, Hirsch IB. New medications for the treatment of diabetes. Diabetes Technol Ther. 2022;24(S1):S190-S208. doi:10.1089/dia.2022.2513

58. Melton D. The promise of stem cell-derived islet replacement therapy. Diabetologia. 2021;64(5):1030-1036. doi:10.1007/s00125-020-05367-2

59. Danne T, Heinemann L, Bolinder J. New insulins, biosimilars, and insulin therapy. Diabetes Technol Ther. 2022;24(S1):S35-S57. doi:10.1089/dia.2022.2503

60. Kenney J. Insulin copay caps–a path to affordability. July 6, 2021. Accessed August 30, 2022.https://diatribechange.org/news/insulin-copay-caps-path-affordability

61. Glied SA, Zhu B. Not so sweet: insulin affordability over time. September 25, 2020. Accessed August 30, 2022. https://www.commonwealthfund.org/publications/issue-briefs/2020/sep/not-so-sweet-insulin-affordability-over-time

62. American Diabetes Association. Insulin and drug affordability. Accessed August 30, 2022. https://www.diabetes.org/advocacy/insulin-and-drug-affordability

63. Sullivan P. Chances for drug pricing, surprise billing action fade until November. March 24, 2020. Accessed August 30, 2022. https://thehill.com/policy/healthcare/489334-chances-for-drug-pricing-surprise-billing-action-fade-until-november/

64. Brown TD. How Medicare’s new Senior Savings Model makes insulin more affordable. June 4, 2020. Accessed August 30, 2022. https://www.diabetes.org/blog/how-medicares-new-senior-savings-model-makes-insulin-more-affordable

65. American Diabetes Association. ADA applauds the U.S. House of Representatives passage of the Affordable Insulin Now Act. News release. April 1, 2022. https://www.diabetes.org/newsroom/official-statement/2022/ada-applauds-us-house-of-representatives-passage-of-the-affordable-insulin-now-act

66. JDRF. Driving T1D cures during challenging times. 2022.

67. Medtronic announces ongoing initiatives to address health equity for people of color living with diabetes. News release. April 7, 2021. Access August 30, 2022. https://bit.ly/3KGTOZU

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