Background: Uptake of exercise in people with type 1 diabetes (T1D) is low despite significant health benefits. Fear of hypoglycemia is the main barrier to exercise. Continuous glucose monitoring (CGM) with predictive alarms warning of impending hypoglycemia may improve self-management of diabetes around exercise. Aim: To assess the impact of Dexcom G6 real-time CGM system with a predictive hypoglycemia alert function on the frequency, duration, and severity of hypoglycemia occurring during and after regular (≥150 min/week) physical activity in people with T1D. Methods: After 10 days of blinded run-in (Baseline), CGM was unblinded and participants randomized 1:1 to have the "urgent low soon" (ULS) alert switched "on" or "off" for 40 days. Participants then switched alerts "off" or "on," respectively, for a further 40 days. Physical activity, and carbohydrate and insulin doses were recorded. Results: Twenty-four participants (8 men, 16 women) were randomized. There was no difference in change from baseline of hypoglycemia <3.0 and <3.9 mmol/L with the ULS on or off during the 24 h after exercise. With ULS alert "on" time spent below 2.8 mmol/L compared with baseline was significantly (P = 0.04) lower than with ULS "off" in the 24 h after exercise. In mixed effects regression, timing of the exercise and baseline HbA1c independently affected risk of hypoglycemia during exercise; exercise timing also affected hypoglycemia risk after exercise. Conclusion: A CGM device with an ULS alert reduces exposure to hypoglycemia below 2.8 mmol/L overall and in the 24 h after exercise compared with a threshold alert.
Background: The Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) is a decision support system using the artificial intelligence technique of case-based reasoning to adapt and personalize insulin bolus doses. The integrated system comprises a smartphone application and clinical web portal. We aimed to assess the safety and efficacy of the ABC4D (intervention) compared with a nonadaptive bolus calculator (control).Methods: This was a prospective randomized controlled crossover study. Following a 2-week run-in period, participants were randomized to ABC4D or control for 12 weeks. After a 6-week washout period, participants crossed over for 12 weeks. The primary outcome was difference in % time in range (%TIR) (3.9-10.0 mmol/L [70-180 mg/dL]) change during the daytime (07:00-22:00) between groups.Results: Thirty-seven adults with type 1 diabetes on multiple daily injections of insulin were randomized, median (interquartile range [IQR]) age 44.7 (28.2-55.2) years, diabetes duration 15.0 (9.5-29.0) years, and glycated hemoglobin 61.0 (58.0-67.0) mmol/mol (7.7 [7.5-8.3]%). Data from 33 participants were analyzed. There was no significant difference in daytime %TIR change with ABC4D compared with control (median [IQR] +0.1 [-2.6 to +4.0]% vs. +1.9 [-3.8 to +10.1]%; P = 0.53). Participants accepted fewer meal dose recommendations in the intervention compared with control (78.7 [55.8-97.6]% vs. 93.5 [73.8-100]%; P = 0.009), with a greater reduction in insulin dosage from that recommended.Conclusion: The ABC4D is safe for adapting insulin bolus doses and provided the same level of glycemic control as the nonadaptive bolus calculator. Results suggest that participants did not follow the ABC4D recommendations as frequently as control, impacting its effectiveness.
Background Uptake of exercise in people with Type 1 Diabetes is low despite significant health benefits. Fear of hypoglycaemia is the main barrier to exercise. Continuous glucose monitoring with predictive alarms warning of impending hypoglycaemia may improve self-management of diabetes around exercise. Aim To assess the impact of Dexcom G6 real-time continuous glucose monitoring (CGM) system with a predictive hypoglycaemia alert function on the frequency, duration and severity of hypoglycaemia occurring during and after regular (150min/week) physical activity in people with T1D. Methods After 10 days of blinded run-in (Baseline), CGM was unblinded and participants randomised 1:1 to have the "urgent low soon" (ULS) alert switched 'on' or 'off' for 40 days. Participants then switched alerts 'off' or 'on' respectively for a further 40 days. Physical activity, carbohydrate and insulin doses were recorded. Results Twenty-four participants (8 men, 16 women) were randomised. There was no difference in change from baseline of hypoglycaemia <3.0 and <3.9mmol/L with the ULS on or off during the 24 hours after exercise. With ULS alert 'on' time spent below 2.8mmol/L compared to baseline was significantly (p=0.04) lower than with ULS 'off' in the 24 hours after exercise. In mixed effects regression, timing of the exercise and baseline HbA1c independently affected risk of hypoglycaemia during exercise; exercise timing also affected hypoglycaemia risk after exercise. Conclusion A CGM device with an Urgent Low Soon alert reduces exposure to hypoglycaemia below 2.8mmol/l overall and in the 24 hours after exercise compared to a threshold alert.
Most people living with type 1 diabetes self‐manage using multiple daily injection (MDI) insulin regimens and self‐monitoring of blood glucose (SMBG). Continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) are adjuncts to education and support self‐management optimization. The aim of this systematic review and meta‐analysis was to assess which first‐line technology is most effective.
Background: The Patient Empowerment through Predictive Personalized Decision Support (PEPPER) system provides personalized bolus advice for people with type 1 diabetes. The system incorporates an adaptive insulin recommender system (based on case-based reasoning, an artificial intelligence methodology), coupled with a safety system, which includes predictive glucose alerts and alarms, predictive low-glucose suspend, personalized carbohydrate recommendations, and dynamic bolus insulin constraint. We evaluated the safety and efficacy of the PEPPER system compared to a standard bolus calculator. Methods: This was an open-labeled multicenter randomized controlled crossover study. Following 4-week run-in, participants were randomized to PEPPER/Control or Control/PEPPER in a 1:1 ratio for 12 weeks. Participants then crossed over after a washout period. The primary end-point was percentage time in range (TIR, 3.9-10.0 mmol/L [70-180 mg/dL]). Secondary outcomes included glycemic variability, quality of life, and outcomes on the safety system and insulin recommender. Results: Fifty-four participants on multiple daily injections (MDI) or insulin pump completed the run-in period, making up the intention-to-treat analysis. Median (interquartile range) age was 41.5 (32.3-49.8) years, diabetes duration 21.0 (11.5-26.0) years, and HbA1c 61.0 (58.0-66.1) mmol/mol. No significant difference was observed for percentage TIR between the PEPPER and Control groups (62.5 [52.1-67.8] % vs. 58.4 [49.6-64.3] %, respectively, P = 0.27). For quality of life, participants reported higher perceived hypoglycemia with the PEPPER system despite no objective difference in time spent in hypoglycemia. Conclusions: The PEPPER system was safe, but did not change glycemic outcomes, compared to control. There is wide scope for integrating PEPPER into routine diabetes management for pump and MDI users. Further studies are required to confirm overall effectiveness.