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Objective: Exercise is known to increase the risk for hypoglycemia in type 1 diabetes (T1D) but predicting when it may occur remains a major challenge. The objective of this study was to develop a hypoglycemia prediction model based on a large real-world study of exercise in T1D. Research Design and Methods: Structured study-specified exercise (aerobic, interval, and resistance training videos) and free-living exercise sessions from the T1D Exercise Initiative study were used to build a model for predicting hypoglycemia, a continuous glucose monitoring value <70 mg/dL, during exercise. Repeated measures random forest (RMRF) and repeated measures logistic regression (RMLR) models were constructed to predict hypoglycemia using predictors at the start of exercise and baseline characteristics. Models were evaluated with area under the receiver operating characteristic curve (AUC) and balanced accuracy. Results: RMRF and RMLR had similar AUC (0.833 vs. 0.825, respectively) and both models had a balanced accuracy of 77%. The probability of hypoglycemia was higher for exercise sessions with lower pre-exercise glucose levels, negative pre-exercise glucose rates of change, greater percent time <70 mg/dL in the 24 h before exercise, and greater pre-exercise bolus insulin-on-board (IOB). Free-living aerobic exercises, walking/hiking, and physical labor had the highest probability of hypoglycemia, while structured exercises had the lowest probability of hypoglycemia. Conclusions: RMRF and RMLR accurately predict hypoglycemia during exercise and identify factors that increase the risk of hypoglycemia. Lower glucose, decreasing levels of glucose before exercise, and greater pre-exercise IOB largely predict hypoglycemia risk in adults with T1D. [ABSTRACT FROM AUTHOR]

Background: Despite new glucose sensing technologies, nocturnal hypoglycemia is still a problem for people with type 1 diabetes (T1D) as symptoms and sensor alarms may not be detected while sleeping. Accurately predicting nocturnal hypoglycemia before sleep may help minimize nighttime hypoglycemia. Methods: A support vector regression (SVR) model was trained to predict, before bedtime, the overnight minimum glucose and overnight nocturnal hypoglycemia for people with T1D. The algorithm was trained on continuous glucose measurements and insulin data collected from 124 people (22,804 valid nights of data) with T1D. The minimum glucose threshold for announcing nocturnal hypoglycemia risk was derived by applying a decision theoretic criterion to maximize expected net benefit. Accuracy was evaluated on a validation set from 10 people with T1D during a 4-week trial under free-living sensor-augmented insulin-pump therapy. The primary outcome measures were sensitivity and specificity of prediction, the correlation between predicted and actual minimum nocturnal glucose, and root-mean-square error. The impact of using the algorithm to prevent nocturnal hypoglycemia is shown in-silico. Results: The algorithm predicted 94.1% of nocturnal hypoglycemia events (<3.9 mmol/L, 95% confidence interval [CI], 71.3-99.9) with an area under the receiver operating characteristic curve of 0.86 (95% CI, 0.75-0.98). Correlation between actual and predicted minimum glucose was high (R = 0.71, P < 0.001). In-silico simulations showed that the algorithm could reduce nocturnal hypoglycemia by 77.0% (P = 0.006) without impacting time in target range (3.9-10 mmol/L). Conclusion: An SVR model trained on a big data set and optimized using decision theoretic criterion can accurately predict at bedtime if overnight nocturnal hypoglycemia will occur and may help reduce nocturnal hypoglycemia. [ABSTRACT FROM AUTHOR]

Introduction: DailyDose is a decision support system designed to provide real-time dosing advice and weekly insulin dose adjustments for adults living with type 1 diabetes using multiple daily insulin injections. Materials and Methods: Twenty-five adults were enrolled in this single-arm study. All participants used Dexcom G6 for continuous glucose monitoring, InPen for short-acting insulin doses, and Clipsulin to track long-acting insulin doses. Participants used DailyDose on an iPhone for 8 weeks. The primary endpoint was % time in range (TIR) comparing the 2-week baseline to the final 2-week period of DailyDose use. Results: There were no significant differences between TIR or other glycemic metrics between the baseline period compared to final 2-week period of DailyDose use. TIR significantly improved by 6.3% when more than half of recommendations were accepted and followed compared with 50% or fewer recommendations (95% CI 2.5%-10.1%, P = 0.001). Conclusions: Use of DailyDose did not improve glycemic outcomes compared to the baseline period. In a post hoc analysis, accepting and following recommendations from DailyDose was associated with improved TIR. Clinical Trial Registration Number: NCT04428645. [ABSTRACT FROM AUTHOR]

Objective: This study analysis was designed to examine the 24-h effects of exercise on glycemic control as measured by continuous glucose monitoring (CGM). Methods: Individuals with type 1 diabetes (ages: 15-68 years; hemoglobin A1c: 7.5% ± 1.5% [mean ± standard deviation (SD)]) were randomly assigned to complete twice-weekly aerobic, high-intensity interval, or resistance-based exercise sessions in addition to their personal exercise sessions for a period of 4 weeks. Exercise was tracked with wearables and glucose concentrations assessed using CGM. An exercise day was defined as a 24-h period after the end of exercise, while a sedentary day was defined as any 24-h period with no recorded exercise ≥10 min long. Sedentary days start at least 24 h after the end of exercise. Results: Mean glucose was lower (150 ± 45 vs. 166 ± 49 mg/dL, P = 0.01), % time in range [70-180 mg/dL] higher (62% ± 23% vs. 56% ± 25%, P = 0.03), % time >180 mg/dL lower (28% ± 23% vs. 37% ± 26%, P = 0.01), and % time <70 mg/dL higher (9.3% ± 11.0% vs. 7.1% ± 9.1%, P = 0.04) on exercise days compared with sedentary days. Glucose variability and % time <54 mg/dL did not differ significantly between exercise and sedentary days. No significant differences in glucose control by exercise type were observed. Conclusion: Participants had lower 24-h mean glucose levels and a greater time in range on exercise days compared with sedentary days, with mode of exercise affecting glycemia similarly. In summary, this study offers data supporting frequency of exercise as a method of facilitating glucose control but does not suggest an effect for mode of exercise. [ABSTRACT FROM AUTHOR]

Objective: Several studies have shown that closed-loop automated insulin delivery (the artificial pancreas) improves glucose control compared with sensor-augmented pump therapy. We aimed to confirm these findings using our automated insulin delivery system based on the iPancreas platform. Research Design and Methods: We conducted a two-center, randomized crossover trial comparing automated insulin delivery with sensor-augmented pump therapy in 36 adults with type 1 diabetes. Each intervention lasted 12 days in outpatient free-living conditions with no remote monitoring. The automated insulin delivery system used a model predictive control algorithm that was a less aggressive version of our earlier dosing algorithm to emphasize safety. The primary outcome was time in the range 3.9-10.0 mmol/L. Results: The automated insulin delivery system was operational 90.2% of the time. Compared with the sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (interquartile range 53-74) to 69% (60-73; P = 0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30-49) to 45% (35-51; P = 0.011). Automated insulin delivery also reduced time spent below 3.9 and 3.3 mmol/L from 3.5% (0.8-5.4) to 1.6% (1.1-2.7; P = 0.0021) and from 0.9% (0.2-2.1) to 0.5% (0.2-1.1; P = 0.0122), respectively. Time spent below 2.8 mmol/L was 0.2% (0.0-0.6) with sensor-augmented pump therapy and 0.1% (0.0-0.4; P = 0.155) with automated insulin delivery. Conclusions: Our study confirms findings that automated insulin delivery improves glucose control compared with sensor-augmented pump therapy. ClinicalTrials.gov no. NCT02846831. [ABSTRACT FROM AUTHOR]

Background: People with type 1 diabetes estimate meal carbohydrate content to accurately dose insulin, yet, protein and fat content of meals also influences postprandial glycemia. We examined accuracy of macronutrient content estimation via a novel phone app. Participant estimates were compared with expert nutrition analyses performed via the Remote Food Photography Method© (RFPM©). Methods: Data were collected through a novel phone app. Participants were asked to take photos of meals/snacks on the day of and day after scheduled exercise, enter carbohydrate estimates, and categorize meals as low, typical, or high protein and fat. Glycemia was measured via continuous glucose monitoring. Results: Participants (n = 48) were 15-68 years (34 ± 14 years); 40% were female. The phone app plus RFPM© analysis captured 88% ± 29% of participants' estimated total energy expenditure. The majority (70%) of both low-protein and low-fat meals were accurately classified. Only 22% of high-protein meals and 17% of high-fat meals were accurately classified. Forty-nine percent of meals with <30 g of carbohydrates were overestimated by an average of 25.7 ± 17.2 g. The majority (64%) of large carbohydrate meals (≥60 g) were underestimated by an average of 53.6 ± 33.8 g. Glycemic response to large carbohydrate meals was similar between participants who underestimated or overestimated carbohydrate content, suggesting that factors beyond carbohydrate counting may impact postprandial glycemic response. Conclusions: Accurate estimation of total macronutrients in meals could be leveraged to improve insulin decision support tools and closed loop insulin delivery systems; development of tools to improve macronutrient estimation skills should be considered. [ABSTRACT FROM AUTHOR]

Background: People with type 1 diabetes estimate meal carbohydrate content to accurately dose insulin, yet, protein and fat content of meals also influences postprandial glycemia. We examined accuracy of macronutrient content estimation via a novel phone app. Participant estimates were compared with expert nutrition analyses performed via the Remote Food Photography Method© (RFPM©). Methods: Data were collected through a novel phone app. Participants were asked to take photos of meals/snacks on the day of and day after scheduled exercise, enter carbohydrate estimates, and categorize meals as low, typical, or high protein and fat. Glycemia was measured via continuous glucose monitoring. Results: Participants (n = 48) were 15–68 years (34 ± 14 years); 40% were female. The phone app plus RFPM© analysis captured 88% ± 29% of participants' estimated total energy expenditure. The majority (70%) of both low-protein and low-fat meals were accurately classified. Only 22% of high-protein meals and 17% of high-fat meals were accurately classified. Forty-nine percent of meals with <30 g of carbohydrates were overestimated by an average of 25.7 ± 17.2 g. The majority (64%) of large carbohydrate meals (≥60 g) were underestimated by an average of 53.6 ± 33.8 g. Glycemic response to large carbohydrate meals was similar between participants who underestimated or overestimated carbohydrate content, suggesting that factors beyond carbohydrate counting may impact postprandial glycemic response. Conclusions: Accurate estimation of total macronutrients in meals could be leveraged to improve insulin decision support tools and closed loop insulin delivery systems; development of tools to improve macronutrient estimation skills should be considered. [ABSTRACT FROM AUTHOR]

Background: Optimizing programmed basal rates and carbohydrate ratios may improve the performance of the artificial pancreas. We tested, in a diabetes camp, the efficacy of a learning algorithm that updates daily basal rates and carbohydrate ratios in the artificial pancreas. Materials and Methods: We conducted a randomized crossover trial in campers and counselors aged 8-21 years with type 1 diabetes on pump therapy. Participants underwent 2 days of artificial pancreas alone and 6 days of artificial pancreas with learning. During the artificial pancreas with learning, programmed basal rates and carbohydrate ratios were updated daily based on the learning algorithm's recommendations. All algorithm recommendations were reviewed for safety by camp physicians. The primary outcome was the time in target range (3.9-10 mmol/L) of the last 2 days of each intervention. Results: Thirty-four campers (age 13.9 ± 3.9, hemoglobin A1c 8.3% ± 0.2%) were included. Ninety-six percent of algorithm recommendations were approved by the camp physicians. Participants were in closed-loop mode 74% of the time. There was no difference between interventions in time in target (55%-55%; P = 0.71) nor in hypoglycemia events (0.8-0.9 events per day; P = 0.63). This was despite changes in programmed basal rate ranging from -21% to +117%, and changes in breakfast, lunch, and supper carbohydrate ratios from -17% to +40%, -36% to +37%, and -35% to +63%, respectively. Morever, postprandial hyperglycemia and hypoglycemia did not decrease in participants whose carbohydrate ratios were decreased (more insulin boluses) and increased (less insulin boluses), respectively. Conclusions: In camp settings, despite adjustments to programmed basal rates and carbohydrate ratios, the learning algorithm did not change glycemia, which may point toward limited effect of these adjustments in environments with large day-to-day variability in insulin needs. Longer randomized studies in real-world settings are required to further assess the efficacy of automatic adjustments of programmed basal rates and carbohydrate ratios. [ABSTRACT FROM AUTHOR]