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Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy.

ABSTRACT: To test whether adjusting insulin and glucagon in response to exercise within a dual-hormone artificial pancreas (AP) reduces exercise-related hypoglycaemia.In random order, 21 adults with type 1 diabetes (T1D) underwent three 22-hour experimental sessions: AP with exercise dosing adjustment (APX); AP with no exercise dosing adjustment (APN); and sensor-augmented pump (SAP) therapy. After an overnight stay and 2?hours after breakfast, participants exercised for 45?minutes at 60% of their maximum heart rate, with no snack given before exercise. During APX, insulin was decreased and glucagon was increased at exercise onset, while during SAP therapy, subjects could adjust dosing before exercise. The two primary outcomes were percentage of time spent in hypoglycaemia (<3.9?mmol/L) and percentage of time spent in euglycaemia (3.9-10?mmol/L) from the start of exercise to the end of the study.The mean (95% confidence interval) times spent in hypoglycaemia (<3.9?mmol/L) after the start of exercise were 0.3% (-0.1, 0.7) for APX, 3.1% (0.8, 5.3) for APN, and 0.8% (0.1, 1.4) for SAP therapy. There was an absolute difference of 2.8% less time spent in hypoglycaemia for APX versus APN (p?=?.001) and 0.5% less time spent in hypoglycaemia for APX versus SAP therapy (p?=?.16). Mean time spent in euglycaemia was similar across the different sessions.Adjusting insulin and glucagon delivery at exercise onset within a dual-hormone AP significantly reduces hypoglycaemia compared with no adjustment and performs similarly to SAP therapy when insulin is adjusted before exercise.

SUBMITTER: Jacobs PG

PROVIDER: S-EPMC5056819 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy.

Jacobs P G PG El Youssef J J Reddy R R Resalat N N Branigan D D Condon J J Preiser N N Ramsey K K Jones M M Edwards C C Kuehl K K Leitschuh J J Rajhbeharrysingh U U Castle J R JR

Diabetes, obesity & metabolism 20160815 11

<h4>Aims</h4>To test whether adjusting insulin and glucagon in response to exercise within a dual-hormone artificial pancreas (AP) reduces exercise-related hypoglycaemia.<h4>Materials and methods</h4>In random order, 21 adults with type 1 diabetes (T1D) underwent three 22-hour experimental sessions: AP with exercise dosing adjustment (APX); AP with no exercise dosing adjustment (APN); and sensor-augmented pump (SAP) therapy. After an overnight stay and 2 hours after breakfast, participants exerc ...[more]

PMID: 27333970

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Project description:BackgroundExercise challenges people with type 1 diabetes in controlling their glucose concentration (GC). A multivariable adaptive artificial pancreas (MAAP) may lessen the burden.MethodsThe MAAP operates without any user input and computes insulin based on continuous glucose monitor and physical activity signals. To analyze performance, 18 60-h closed-loop experiments with 96 exercise sessions with three different protocols were completed. Each day, the subjects completed one resistance and one treadmill exercise (moderate continuous training [MCT] or high-intensity interval training [HIIT]). The primary outcome is time spent in each glycemic range during the exercise + recovery period. Secondary measures include average GC and average change in GC during each exercise modality.ResultsThe GC during exercise + recovery periods were within the euglycemic range (70-180?mg/dL) for 69.9% of the time and within a safe glycemic range for exercise (70-250?mg/dL) for 93.0% of the time. The exercise sessions are defined to begin 30?min before the start of exercise and end 2?h after start of exercise. The GC were within the severe hypoglycemia (<55?mg/dL), moderate hypoglycemia (55-70?mg/dL), moderate hyperglycemia (180-250?mg/dL), and severe hyperglycemia (>250?mg/dL) for 0.9%, 1.3%, 23.1%, and 4.8% of the time, respectively. The average GC decline during exercise differed with exercise type (P?=?0.0097) with a significant difference between the MCT and resistance (P?=?0.0075). To prevent large GC decreases leading to hypoglycemia, MAAP recommended carbohydrates in 59% of MCT, 50% of HIIT, and 39% of resistance sessions.ConclusionsA consistent GC decline occurred in exercise and recovery periods, which differed with exercise type. The average GC at the start of exercise was above target (185.5?±?56.6?mg/dL for MCT, 166.9?±?61.9?mg/dL for resistance training, and 171.7?±?41.4?mg/dL HIIT), making a small decrease desirable. Hypoglycemic events occurred in 14.6% of exercise sessions and represented only 2.22% of the exercise and recovery period.

Project description:BackgroundOlder adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes.MethodsIn an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762.Findings38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63-70] years, mean [SD] baseline glycated haemoglobin [HbA1c]; 7·4% [0·9%]; 57 [10] mmol/mol) were randomly assigned between Sept 4, 2019, and Oct 2, 2020. The proportion of time with glucose between 3·9 and 10·0 mmol/L was significantly higher in the closed-loop group compared to the SAP group (79·9% [SD 7·9] vs 71·4% [13·2], difference 8·6 percentage points [95% CI 6·3 to 11·0]; p<0·0001). Two severe hypoglycaemia events occurred during the SAP period. There were two non-treatment related serious adverse events: cardiac arrest from pulmonary embolism associated with COVID-19 during the SAP period resulting in death, and a hospital presentation for parenteral hydrocortisone because of COVID-19 in a participant with adrenal insufficiency during the run-in period.InterpretationHybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.

Dataset Information

Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy.

Publications

Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy.

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