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| Name | Class |
|---|---|
| Swansea University | OTHER |
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Despite the promising data emanating from trials investigating the effectiveness of advanced hybrid closed loop (AHCL) insulin delivery systems in managing glycaemia in those with type 1 diabetes (T1D), we currently know little about their efficacy in optimising glycaemia when physical activity is factored into the equation. With the introduction of new AHCL systems that have novel technological features, we are left with important questions of how to optimise their use around physical exercise to not only minimise dysglycaemia, but also encourage individuals with T1D to lead a physically active lifestyle for the associated wider health benefits.
This will be a three-period, randomised, cross-over study with a single-hormone (insulin) AHCL system that compares the efficacy of three insulin management strategies: (i) unannounced exercise and a full dose of meal-time insulin 90-minutes prior to commencement, (ii) a 25% reduced dose of meal-time insulin with exercise announcement 90-minutes prior to commencement and (iii) a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement, in optimising TIR around dynamic physical exercise in adults with T1D.
Following successful completion of a screening visit, participants will attend the laboratory to complete 3 experimental visits during which they will undertake a 45-minute bout of moderate intensity continuous exercise on a bicycle ergometer at ~60% VȮ2max. Prior to commencing exercise, participants will consume a standardised low-glycaemic index, carbohydrate-based meal (equating to 0.75g.CHO.kg.bm-1) with, or without, a 25% reduction in their meal-time insulin dose as well as with, or without exercise announcement (according to the randomisation). Exercise announcement will increase the individualised target glucose levels to 8.3 mmol.L-1. Venous blood glucose sampling will be taken in 15-minute intervals leading into and after exercise with 5-minute intervals performed during exercise. Samples will be used to retrospectively cross-compare trial day glycaemic responses between visits. Each participant will undertake 1 screening and 3 experimental visits equating to a total of 80 study visits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART A1 | Experimental | A full dose of meal-time insulin with announced exercise immediately prior to commencement |
|
| SMART A2 | Experimental | a 25% dose reduction in meal-time insulin with exercise announcement 90-minutes prior to commencement |
|
| SMART A3 | Experimental | a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pump settings | Other | Alteration in the pump setting prior to exercise commencement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise. | To compare the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise | -90 min to +105 min |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the occurrence of BG hypoglycaemic events | Comparison of the occurrence of blood glucose hypoglycaemic events before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of the depth of BG hypoglycaemic events |
Inclusion Criteria:
• Type 1 diabetes ≥2 years.
HbA1c;
Insulin pump treatment ≥12 months
CGM or isCGM use ≥6 months
Novorapid use ≥4 weeks
Carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals.
Carbohydrate intake >80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit)
Exclusion Criteria:
• Breast-feeding, pregnancy or planning to become pregnant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Gentofte Municipality | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37053529 | Derived | McCarthy OM, Christensen MB, Kristensen KB, Schmidt S, Ranjan AG, Bain SC, Bracken RM, Norgaard K. Automated Insulin Delivery Around Exercise in Adults with Type 1 Diabetes: A Pilot Randomized Controlled Study. Diabetes Technol Ther. 2023 Jul;25(7):476-484. doi: 10.1089/dia.2023.0009. Epub 2023 May 8. | |
| 36482870 | Derived |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Comparison of the depth of blood glucose hypoglycaemic events before during and 1 hour after exercise
| -90 min to +105 min |
| Comparison of mean BG concentrations | Comparison of mean blood glucose concentrations before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of the standard deviation in BG concentrations | Comparison of the standard deviation in blood glucose concentrations before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of the coefficient of variation in BG concentrations | Comparison of the coefficient of variation in blood glucose concentrations before during and 1 hour after exercise | -90 min to +105min |
| Comparison of the minimum BG concentration | Comparison of the minimum blood glucose concentration before during and 1 hour after exercise | -90 min to +105min |
| Comparison of the maximum BG concentration | Comparison of the maximum blood glucose concentration before during and 1 hour after exercise | -90 min to +105min |
| ΔBGexercise: Changes in BG concentrations during exercise | ΔBGexercise: Changes in blood glucose concentrations during exercise | 0 min to +45 min |
| ΔiGexercise: Changes in iG concentrations during exercise | ΔiGexercise: Changes in interstitial glucose concentrations during exercise | 0 min to +45 min |
| ΔBGfeeding: Change in BG concentrations after feeding | ΔBGfeeding: Change in blood glucose concentrations after feeding | -90 min to 0min |
| ΔiGfeeding: Change in iG concentrations after feeding | ΔiGfeeding: Change in interstitial glucose concentrations after feeding | -90 min to 0min |
| Comparison of TBR level 2 in iG values | Comparison of TBR level 2 in interstitial glucose values before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of TBR level 1 in iG values | Comparison of TBR level 1 in interstitial glucose values before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of TAR level 1 in iG values | Comparison of the amount of time spent with interstitial glucose values above the target range level 1 before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of TAR level 2 in iG values | Comparison of the amount of time spent with interstitial glucose values above the target range level 2 before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of mean iG concentrations | Comparison of mean interstitial glucose concentrations before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of the standard deviation in iG concentrations | Comparison of the standard deviation in interstitial glucose concentrations before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of the coefficient of variation in iG concentrations | Comparison of the coefficient of variation in interstitial glucose concentrations before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of the minimum iG concentration | Comparison of the minimum interstitial glucose concentration before during and 1 hour after exercise | -90 min to +105 min |
| Comparison of the maximum iG concentration | Comparison of the maximum interstitial glucose concentration before during and 1 hour after exercise | -90 min to +105 min |
| McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, Ranjan AG, Nicholas C, Bain SC, Norgaard K, Bracken R. Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy. Diabetes Obes Metab. 2023 Mar;25(3):878-888. doi: 10.1111/dom.14938. Epub 2023 Jan 3. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |