Clinical trial NCT05134025: The SMART A Exercise Study :''The SMART Study''
Official title: Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study''
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Swansea University
First posted: 2021-11-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* • Type 1 diabetes ≥2 years.

  * HbA1c;

    * 58-63 mmol/mol (maximum 30% of participants) OR
    * ≥ 64 mmol/mol (minimum 70% of participants)
  * 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.

  * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
  * Use of hybrid closed-loop systems
  * Daily use of paracetamol (acetaminophen)
  * Alcohol or drug abuse.
  * Severe cardiac disease or retinopathy contraindicating HbA1c \<53 mmol/mol.
  * Other concomitant medical or psychological condition that according to the investigator's assessment makes the person unsuitable for study participation.
  * Lack of compliance with key study procedures at the discretion of the investigator.
  * Unacceptable adverse events at the discretion of the investigator.

Primary outcomes:
measure: Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise.
timeFrame: -90 min to +105 min
Secondary outcomes:
Other outcomes:
measure: Comparison of the occurrence of BG hypoglycaemic events
timeFrame: -90 min to +105 min
measure: Comparison of the depth of BG hypoglycaemic events
timeFrame: -90 min to +105 min
measure: Comparison of mean BG concentrations
timeFrame: -90 min to +105 min
measure: Comparison of the standard deviation in BG concentrations
timeFrame: -90 min to +105 min
measure: Comparison of the coefficient of variation in BG concentrations
timeFrame: -90 min to +105min
measure: Comparison of the minimum BG concentration
timeFrame: -90 min to +105min
measure: Comparison of the maximum BG concentration
timeFrame: -90 min to +105min
measure: ΔBGexercise: Changes in BG concentrations during exercise
timeFrame: 0 min to +45 min
measure: ΔiGexercise: Changes in iG concentrations during exercise
timeFrame: 0 min to +45 min
measure: ΔBGfeeding: Change in BG concentrations after feeding
timeFrame: -90 min to 0min
measure: ΔiGfeeding: Change in iG concentrations after feeding
timeFrame: -90 min to 0min
measure: Comparison of TBR level 2 in iG values
timeFrame: -90 min to +105 min
measure: Comparison of TBR level 1 in iG values
timeFrame: -90 min to +105 min
measure: Comparison of TAR level 1 in iG values
timeFrame: -90 min to +105 min
measure: Comparison of TAR level 2 in iG values
timeFrame: -90 min to +105 min
measure: Comparison of mean iG concentrations
timeFrame: -90 min to +105 min
measure: Comparison of the standard deviation in iG concentrations
timeFrame: -90 min to +105 min
measure: Comparison of the coefficient of variation in iG concentrations
timeFrame: -90 min to +105 min
measure: Comparison of the minimum iG concentration
timeFrame: -90 min to +105 min
measure: Comparison of the maximum iG concentration
timeFrame: -90 min to +105 min
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
References: