Back to resultsThe SMART A Exercise Study :''The SMART Study'' (SMART)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pump settings
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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.
Sites / Locations
- Steno Diabetes Center Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SMART A1
SMART A2
SMART A3
Arm Description
A full dose of meal-time insulin with announced exercise immediately prior to commencement
a 25% dose reduction in meal-time insulin with exercise announcement 90-minutes prior to commencement
a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement
Outcomes
Primary Outcome Measures
Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise.
To compare the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise
Secondary Outcome Measures
Full Information
NCT ID
NCT05134025
First Posted
September 14, 2021
Last Updated
October 31, 2022
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Swansea University
1. Study Identification
Unique Protocol Identification Number
NCT05134025
Brief Title
The SMART A Exercise Study :''The SMART Study''
Acronym
SMART
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
August 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Swansea University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMART A1
Arm Type
Experimental
Arm Description
A full dose of meal-time insulin with announced exercise immediately prior to commencement
Arm Title
SMART A2
Arm Type
Experimental
Arm Description
a 25% dose reduction in meal-time insulin with exercise announcement 90-minutes prior to commencement
Arm Title
SMART A3
Arm Type
Experimental
Arm Description
a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement
Intervention Type
Other
Intervention Name(s)
Pump settings
Intervention Description
Alteration in the pump setting prior to exercise commencement
Primary Outcome Measure Information:
Title
Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise.
Description
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
Other Pre-specified Outcome Measures:
Title
Comparison of the occurrence of BG hypoglycaemic events
Description
Comparison of the occurrence of blood glucose hypoglycaemic events before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of the depth of BG hypoglycaemic events
Description
Comparison of the depth of blood glucose hypoglycaemic events before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of mean BG concentrations
Description
Comparison of mean blood glucose concentrations before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of the standard deviation in BG concentrations
Description
Comparison of the standard deviation in blood glucose concentrations before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of the coefficient of variation in BG concentrations
Description
Comparison of the coefficient of variation in blood glucose concentrations before during and 1 hour after exercise
Time Frame
-90 min to +105min
Title
Comparison of the minimum BG concentration
Description
Comparison of the minimum blood glucose concentration before during and 1 hour after exercise
Time Frame
-90 min to +105min
Title
Comparison of the maximum BG concentration
Description
Comparison of the maximum blood glucose concentration before during and 1 hour after exercise
Time Frame
-90 min to +105min
Title
ΔBGexercise: Changes in BG concentrations during exercise
Description
ΔBGexercise: Changes in blood glucose concentrations during exercise
Time Frame
0 min to +45 min
Title
ΔiGexercise: Changes in iG concentrations during exercise
Description
ΔiGexercise: Changes in interstitial glucose concentrations during exercise
Time Frame
0 min to +45 min
Title
ΔBGfeeding: Change in BG concentrations after feeding
Description
ΔBGfeeding: Change in blood glucose concentrations after feeding
Time Frame
-90 min to 0min
Title
ΔiGfeeding: Change in iG concentrations after feeding
Description
ΔiGfeeding: Change in interstitial glucose concentrations after feeding
Time Frame
-90 min to 0min
Title
Comparison of TBR level 2 in iG values
Description
Comparison of TBR level 2 in interstitial glucose values before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of TBR level 1 in iG values
Description
Comparison of TBR level 1 in interstitial glucose values before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of TAR level 1 in iG values
Description
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
Title
Comparison of TAR level 2 in iG values
Description
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
Title
Comparison of mean iG concentrations
Description
Comparison of mean interstitial glucose concentrations before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of the standard deviation in iG concentrations
Description
Comparison of the standard deviation in interstitial glucose concentrations before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of the coefficient of variation in iG concentrations
Description
Comparison of the coefficient of variation in interstitial glucose concentrations before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of the minimum iG concentration
Description
Comparison of the minimum interstitial glucose concentration before during and 1 hour after exercise
Time Frame
-90 min to +105 min
Title
Comparison of the maximum iG concentration
Description
Comparison of the maximum interstitial glucose concentration before during and 1 hour after exercise
Time Frame
-90 min to +105 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
12. IPD Sharing Statement
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The SMART A Exercise Study :''The SMART Study''
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