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

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ClinicalTrials.gov Identifier: NCT05133765
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 14, 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 ]
Comparison of the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise(i.e., -90 min to +105min).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2021)
To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise(i.e., 0 min to +45 min). [ Time Frame: 0 min to +45 min ]
To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise(i.e., 0 min to +45 min).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 15, 2021)
  • 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 for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -90 min to +105min)
  • Comparison of standard deviation in BG concentrations-90 min to +105min [ Time Frame: -90 min to +105min ]
    Comparison of standard deviation in blood glucose concentrations before, during and for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -90 min to +105min)
  • 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 for 1 hour after physical exercise (i.e., -90 min to +105min)
  • ΔBGexercise: Comparison of the changes in BG during exercise0 min to +45min [ Time Frame: 0 min to +45min ]
    ΔBGexercise: Comparison of the changes in blood glucose during exercise before, during physical exercise (i.e., 0 min to +45min)
  • ΔiGexercise: Comparison of the changes in iG during exercise0 min to +45min. [ Time Frame: 0 min to +45min ]
    ΔiGexercise: Comparison of the changes in interstitial glucose during exercise during physical exercise (i.e., 0 min to +45min)
  • ΔiGfeeding: Comparison of the changes in iG after feeding-90 min to 0 min [ Time Frame: -90 min to 0 min ]
    ΔiGfeeding: Comparison of the changes in interstitial glucose after feeding before physical exercise (i.e., -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 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)
  • Comparison of TBR 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 below the target range level 1 before, during and for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -0 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 after the target range level 2 before, during and for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -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 for 1 hour after physical exercise (i.e., -90 min to +105min)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The SMART B 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 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.

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% 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Three period randomised cross-over clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypoglycemia
Intervention  ICMJE Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA
Alterations in insulin pump therapy
Study Arms  ICMJE
  • Experimental: SMART B1
    Usual care pump therapy arm with carbohydrate consumption before exercise
    Intervention: Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA
  • Experimental: SMART B2
    Advanced hybrid closed loop therapy arm with carbohydrate consumption before exercise
    Intervention: Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA
  • Experimental: SMART B3
    Advanced hybrid closed loop therapy arm with carbohydrate consumption during exercise
    Intervention: Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA
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 30, 2022
Estimated Primary Completion Date September 14, 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 NCT05133765
Other Study ID Numbers  ICMJE SMART B
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