Comparison of Control-IQ and open-source AndroidAPS automated insulin delivery systems in adults with type 1 diabetes: The CODIAC study.

AIM: To compare open-source AndroidAPS (AAPS) and commercially available Control-IQ (CIQ) automated insulin delivery (AID) systems in a prospective, open-label, single-arm clinical trial. METHODS: Adults with type 1 diabetes who had been using AAPS by their own decision entered the first 3-month AAPS phase then were switched to CIQ for 3 months. The results of this treatment were compared with those after the 3-month AAPS phase. The primary endpoint was the change in time in range (% TIR; 70-80 mg/dL). RESULTS: Twenty-five people with diabetes (mean age 34.32 ± 11.07 years; HbA1c 6.4% ± 3%) participated in this study. CIQ was comparable with AAPS in achieving TIR (85.72% ± 7.64% vs. 84.24% ± 8.46%; P = .12). Similarly, there were no differences in percentage time above range (> 180 and > 250 mg/dL), mean sensor glucose (130.3 ± 13.9 vs. 128.3 ± 16.9 mg/dL; P = .21) or HbA1c (6.3% ± 2.1% vs. 6.4% ± 3.1%; P = .59). Percentage time below range (< 70 and < 54 mg/dL) was significantly lower using CIQ than AAPS. Even although participants were mostly satisfied with CIQ (63.6% mostly agreed, 9.1% strongly agreed), they did not plan to switch to CIQ. CONCLUSIONS: The CODIAC study is the first prospective study investigating the switch between open-source and commercially available AID systems. CIQ and AAPS were comparable in achieving TIR. However, hypoglycaemia was significantly lower with CIQ.

Sulfonylurea derivatives and risk of hypoglycaemia in type 2 diabetic patients.

Hypoglycemia related to treatment of type 2 diabetes mellitus patients constantly represents a substantial problem. It is connected with higher mortality and lower quality of life, mostly displayed with elder patients. Therefore it is vital to revise the antidiabetic therapy regularly and to inquire for the associated risks. Nevertheless, elder patiens are often following the inadvisable treatment by sulphonylureas derivates, which represent the second most risky medication causing hypoglycemia after insulin. In our retrospective study we analysed the occurence of serious hypoglycemia, caused by any factor, with severe diabetics urgently hospitalised at The Department of Internal Medicine of Masaryk Hospital in Ústí nad Labem, in relation to the applied antidiabetic therapy. We suspected a negative influence of hypoglycemizing therapy (above all sulphonylureas) with the elderly patiens. In sum, we hospitalised 32 patients with type 2 diabetes mellitus (average age 76,5 ± 8,2 years), 18 of these using sulphonylureas (average age 77,4, with a relatively wide range from 65 to alarming 93 years). The average figure of estimated glomerular filtration rate (eGFR) was 0,745 (±0,293) ml/s/1,73m2. Moreover, the patients manifested polmorbidity - the average of comorbidities was 3,125, and even 3,5 with patiens on sulphonylureas. Following the arguments summarised above, we believe that hypoglycemic episodes are extremely dangerous especially for elder patients with T2DM, and from this point of view, the medication using sulphonylureas derivates seems to be inappropriate.

Lower Glycated Hemoglobin with Real-Time Continuous Glucose Monitoring Than with Intermittently Scanned Continuous Glucose Monitoring After 1 Year: The CORRIDA LIFE Study.

Background: The aim was to compare the efficacy of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) focusing on glycated hemoglobin (HbA1c) as the primary endpoint. Methods: The CORRIDA LIFE was a 12-month, real-world, nonrandomized study that is part of the CORRIDA clinical trials program. The study compared rtCGM (Dexcom G5 or G6) and isCGM (FreeStyle Libre 14-Day; Abbott) in adults with type 1 diabetes (T1D). Only patients on multiple daily insulin injections or continuous subcutaneous insulin infusion with no automatic functions were included in this study. Primary outcome was the difference in HbA1c between study groups at 12 months. Results: One hundred ninety-one adults with T1D (mean age 40 ± 13 years, HbA1c 8.1% ± 3.4% [65 ± 14 mmol/mol]) participated in this study; 81 patients initiated rtCGM and 110 initiated isCGM. After 12-months, HbA1c was significantly lower with rtCGM versus isCGM (7.1% ± 3.1% [54.1 ± 10.1 mmol/mol] vs. 7.7% ± 3.3% [61.2 ± 12.2 mmol/mol]), P = 0.0001. The percentage of time in hypoglycemia (<70 mg/dL [<3.9 mmol/L]) was lower among rtCGM vs. isCGM participants [4.3% ± 2.8% vs. 6.4% ± 5.3%], P = 0.003). Patients with rtCGM spent less time in clinically significant hypoglycemia (<54 mg/dL [<3.0 mmol/L]) (0.9% ± 1.0% vs. 2.3% ± 2.5%, P < 0.0001) and more time in target range (70-180 mg/dL [3.9-10 mmol/L]) than isCGM users (67.5% ± 14.8% vs. 57.8% ± 17.0%), P = 0.0002. Conclusions: rtCGM was superior to isCGM in HbA1c, hypoglycemia, and other glycemic outcomes. Our findings provide guidance to clinicians when discussing monitoring options with their patients. The study was registered at www.clinicaltrials.gov (NCT04759495).

Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial.

OBJECTIVE: The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. RESEARCH DESIGN AND METHODS: In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9-10.0 mmol/L [70-180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems. RESULTS: Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM (n = 30) or isCGM (n = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively; P = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively; P = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9-10 mmol/L [70-180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively; P = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively; P = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm. CONCLUSIONS: rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.