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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

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.


Condition or disease Intervention/treatment Phase
Hypoglycemia Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Three period randomised cross-over clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study''
Actual Study Start Date : September 14, 2021
Estimated Primary Completion Date : September 14, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SMART B1
Usual care pump therapy arm with carbohydrate consumption before exercise
Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA
Alterations in insulin pump therapy

Experimental: SMART B2
Advanced hybrid closed loop therapy arm with carbohydrate consumption before exercise
Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA
Alterations in insulin pump therapy

Experimental: SMART B3
Advanced hybrid closed loop therapy arm with carbohydrate consumption during exercise
Device: Pump therapy. MiniMed 780G, Medtronic Diabetes, Northridge, CA
Alterations in insulin pump therapy




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05133765


Locations
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Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, 2820
Contact: Merete B Christensen    +4523811264    merete.bechmann.christensen@regionh.dk   
Contact: Kirsten Noergaard    +4527131011    kirsten.noergaard@regionh.dk   
Principal Investigator: Merete B. Christensen, MD         
Sub-Investigator: Karen Rytter, RD         
Sub-Investigator: Ajenthen Ranjan, MD         
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Swansea University
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Responsible Party: Merete Bechmann Christensen, Principal Investigator, MD, PhD, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT05133765    
Other Study ID Numbers: SMART B
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases