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The SMART A Exercise Study :''The SMART Study'' (SMART)

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ClinicalTrials.gov Identifier: NCT05134025
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
Swansea University
Information provided by (Responsible Party):
Merete Bechmann Christensen, Steno Diabetes Center Copenhagen

Tracking Information
First Submitted Date  ICMJE September 14, 2021
First Posted Date  ICMJE November 24, 2021
Last Update Posted Date November 24, 2021
Actual Study Start Date  ICMJE September 14, 2021
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2021)
Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise(i.e., -90 min to +105min). [ Time Frame: -90 min to +105min ]
To compare the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 15, 2021)
  • Comparison of the occurrence of BG hypoglycaemic events-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of the occurrence of blood glucose hypoglycaemic events before during and 1 hour after exercise -90 min to +105min
  • Comparison of the depth of BG hypoglycaemic events-90 min to +105min. [ Time Frame: -90 min to +105min ]
    Comparison of the depth of blood glucose hypoglycaemic events before during and 1 hour after exercise -90 min to +105min.
  • Comparison of mean BG concentrations-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of mean blood glucose concentrations before during and 1 hour after exercise -90 min to +105min
  • Comparison of the standard deviation in BG concentrations-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of the standard deviation in blood glucose concentrations before during and 1 hour after exercise -90 min to +105min
  • Comparison of the coefficient of variation in BG concentrations-90 min to +105min [ Time Frame: -90 min to +105min ]
    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-90 min to +105min. [ Time Frame: -90 min to +105min ]
    Comparison of the minimum blood glucose concentration before during and 1 hour after exercise -90 min to +105min.
  • Comparison of the maximum BG concentration-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of the maximum blood glucose concentration before during and 1 hour after exercise -90 min to +105min
  • ΔBGexercise: Changes in BG concentrations during exercise0 min to +45 min [ Time Frame: 0 min to +45 min ]
    ΔBGexercise: Changes in blood glucose concentrations during exercise0 min to +45 min
  • ΔiGexercise: Changes in iG concentrations during exercise0 min to +45 min [ Time Frame: 0 min to +45 min ]
    ΔiGexercise: Changes in interstitial glucose concentrations during exercise0 min to +45 min
  • ΔBGfeeding: Change in BG concentrations after feeding-90 min to 0 min [ Time Frame: -90 min to 0min ]
    ΔBGfeeding: Change in blood glucose concentrations after feeding-90 min to 0 min
  • ΔiGfeeding: Change in iG concentrations after feeding-90 min to 0 min [ Time Frame: -90 min to 0min ]
    ΔiGfeeding: Change in interstitial glucose concentrations after feeding-90 min to 0 min
  • Comparison of TBR level 2 in iG values-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of TBR level 2 in interstitial glucose values before during and 1 hour after exercise -90 min to +105min
  • Comparison of TBR level 1 in iG values-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of TBR level 1 in interstitial glucose values before during and 1 hour after exercise -90 min to +105min
  • Comparison of TAR level 1 in iG values-90 min to +105min [ Time Frame: -90 min to +105min ]
    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 +105min
  • Comparison of TAR level 2 in iG values-90 min to +105min [ Time Frame: -90 min to +105min ]
    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 +105min
  • Comparison of mean iG concentrations-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of mean interstitial glucose concentrations before during and 1 hour after exercise -90 min to +105min
  • Comparison of the standard deviation in iG concentrations-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of the standard deviation in interstitial glucose concentrations before during and 1 hour after exercise -90 min to +105min
  • Comparison of the coefficient of variation in iG concentrations-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of the coefficient of variation in interstitial glucose concentrations before during and 1 hour after exercise -90 min to +105min
  • Comparison of the minimum iG concentration-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of the minimum interstitial glucose concentration before during and 1 hour after exercise -90 min to +105min
  • Comparison of the maximum iG concentration-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of the maximum interstitial glucose concentration before during and 1 hour after exercise -90 min to +105min
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The SMART A Exercise Study :''The SMART Study''
Official Title  ICMJE Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study''
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Other: Pump settings
Alteration in the pump setting prior to exercise commencement
Study Arms  ICMJE
  • Experimental: SMART A1
    A full dose of meal-time insulin with announced exercise 15-minutes prior to commencement
    Intervention: Other: Pump settings
  • Experimental: SMART A2
    a 25% dose reduction in meal-time insulin with exercise announcement 90-minutes prior to commencement
    Intervention: Other: Pump settings
  • Experimental: SMART A3
    a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement
    Intervention: Other: Pump settings
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 14, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05134025
Other Study ID Numbers  ICMJE SMART A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merete Bechmann Christensen, Steno Diabetes Center Copenhagen
Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Collaborators  ICMJE Swansea University
Investigators  ICMJE Not Provided
PRS Account Steno Diabetes Center Copenhagen
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP