Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820, Denmark
NCT Number: NCT05134025
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Gentofte Municipality, 2820, Denmark
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Alteration in the pump setting prior to exercise commencement
Time frame: -90 min to +105 min
To compare the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise
Time frame: -90 min to +105 min
Comparison of the occurrence of blood glucose hypoglycaemic events before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the depth of blood glucose hypoglycaemic events before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of mean blood glucose concentrations before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the standard deviation in blood glucose concentrations before during and 1 hour after exercise
Time frame: -90 min to +105min
Comparison of the coefficient of variation in blood glucose concentrations before during and 1 hour after exercise
Time frame: -90 min to +105min
Comparison of the minimum blood glucose concentration before during and 1 hour after exercise
Time frame: -90 min to +105min
Comparison of the maximum blood glucose concentration before during and 1 hour after exercise
Time frame: 0 min to +45 min
ΔBGexercise: Changes in blood glucose concentrations during exercise
Time frame: 0 min to +45 min
ΔiGexercise: Changes in interstitial glucose concentrations during exercise
Time frame: -90 min to 0min
ΔBGfeeding: Change in blood glucose concentrations after feeding
Time frame: -90 min to 0min
ΔiGfeeding: Change in interstitial glucose concentrations after feeding
Time frame: -90 min to +105 min
Comparison of TBR level 2 in interstitial glucose values before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of TBR level 1 in interstitial glucose values before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the amount of time spent with interstitial glucose values above the target range level 1 before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the amount of time spent with interstitial glucose values above the target range level 2 before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of mean interstitial glucose concentrations before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the standard deviation in interstitial glucose concentrations before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the coefficient of variation in interstitial glucose concentrations before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the minimum interstitial glucose concentration before during and 1 hour after exercise
Time frame: -90 min to +105 min
Comparison of the maximum interstitial glucose concentration before during and 1 hour after exercise
Steno Diabetes Center Copenhagen
Other
Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study''
Acronym: SMART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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