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| Name | Class |
|---|---|
| Swansea University | OTHER |
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Despite the established health benefits conveyed by physical activity for people with type 1 diabetes (T1D), participation rates remain low, with fear of hypoglycaemia, lack of freedom to engage in unplanned activities, and uncertainty in making appropriate adjustments to insulin and nutritional therapy reported as the leading barriers to regular exercise engagement. Indeed, the synergistic glucose lowering effects of peripheral hyperinsulinaemia and exercising muscle tissue accentuate the risk of exercise-related hypoglycaemia for individuals with T1D, particularly if performed post-prandially. Hence, the introduction of commercially available artificial pancreas systems, also known as ''advanced hybrid-closed-loop'' (AHCL) systems, that regulate insulin rates with minimal user interaction constitute compelling therapeutic aids with clinically relevant potential. Nevertheless, we know little about their safe and efficacious integration around dynamic physical exercise. Nor do we know how alterations in carbohydrate fueling strategies around exercise effect subsequent glucose trends.
This study aims to 1) compare the efficacy of an AHCL system versus usual care insulin pump therapy, with carbohydrates taken before or during exercise, in optimising TIR around dynamic physical exercise and 2) explore the influence of carbohydrate intake before versus during exercise on the metabolomic, hormonal and physiological responses to exercise.
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% of the individualised 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 carbohydrates before or during exercise (according to the randomisation). 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 the metabolic, hormonal, and physiological responses between visits. Visits 1 & 2 will be separated by ≥14 days to ensure adequate familiarisation with the AHCL system whilst visits 2 & 3 will be separated by ≥3days. 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 B1 - Usual care insulin pump | Experimental | Usual care pump therapy arm with carbohydrate consumption before exercise |
|
| SMART B2 - Advanced hybrid closed loop insulin pump with carbohydrates before exercise | Experimental | Advanced hybrid closed loop therapy arm with carbohydrate consumption before exercise |
|
| SMART B3 - Advanced hybrid closed loop insulin pump with carbohydrates during exercise | Experimental | Advanced hybrid closed loop therapy arm with carbohydrate consumption during exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump | Device | Alterations in insulin pump therapy or carbohydrate consumption |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise | Comparison of the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise | 0 minutes to +105 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise | To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise | 0 minutes to +45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the maximum BG concentration | Comparison of the maximum blood glucose concentration before, during and for 1 hour after physical exercise | -90 minutes to +105 minutes |
| Comparison of the minimum BG concentration |
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 |
|---|---|---|---|
| 36724311 | Derived | McCarthy OM, Christensen MB, Kristensen KB, Schmidt S, Ranjan AG, Bain SC, Bracken RM, Norgaard K. Glycemia Around Exercise in Adults with Type 1 Diabetes Using Automated and Nonautomated Insulin Delivery Pumps: A Switch Pilot Trial. Diabetes Technol Ther. 2023 Apr;25(4):287-292. doi: 10.1089/dia.2022.0542. Epub 2023 Feb 16. | |
| 36482870 |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
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Three period randomised cross-over clinical trial
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Comparison of the minimum blood glucose concentration before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)
| -90 minutes to +105 minutes |
| Comparison of standard deviation in BG concentrations | Comparison of standard deviation in blood glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 min to +105 minutes |
| Comparison of mean BG concentrations | Comparison of mean blood glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of the depth of BG hypoglycaemic events | Comparison of the depth of blood glucose hypoglycaemic events before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of the occurrence of BG hypoglycaemic events | Comparison of the occurrence of blood glucose hypoglycaemic events before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| ΔBGexercise: Comparison of the changes in BG during exercise | ΔBGexercise: Comparison of the changes in blood glucose during exercise before, during physical exercise (i.e., 0 min to +45min) | 0 minutes to +45 minutes |
| ΔiGexercise: Comparison of the changes in iG during exercise | ΔiGexercise: Comparison of the changes in interstitial glucose during exercise during physical exercise (i.e., 0 min to +45min) | 0 minutes to +45 minutes |
| ΔiGfeeding: Comparison of the changes in iG after feeding | ΔiGfeeding: Comparison of the changes in interstitial glucose after feeding before physical exercise (i.e., -90 min to 0 min) | -90 minutes to 0 minutes |
| Comparison of TBR level 2 in iG values | Comparison of the amount of time spent with interstitial glucose values below the target range level 2 before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of TBR level 1 in iG values | Comparison of the amount of time spent with interstitial glucose values below the target range level 1 before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| 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 for 1 hour after physical exercise (i.e., -0 min to +105min) | -90 minutes to +105 minutes |
| Comparison of TAR level 2 in iG values | Comparison of the amount of time spent with interstitial glucose values after the target range level 2 before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of mean iG concentrations | Comparison of mean interstitial glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of the standard deviation in iG concentrations | Comparison of the standard deviation in interstitial glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of the coefficient of variation in iG concentrations | Comparison of the coefficient of variation in interstitial glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of the minimum iG concentration | Comparison of the minimum interstitial glucose concentration before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| Comparison of the maximum iG concentration | Comparison of the maximum interstitial glucose concentration before, during and for 1 hour after physical exercise (i.e., -90 min to +105min) | -90 minutes to +105 minutes |
| 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. |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |