The SMART A Exercise Study :''The SMART Study''

Type 1 Diabetes Clinical Trial

— SMART  

Official title:

Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study''

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134025
• Other study ID #: SMART A
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: August 23, 2022

Study information

• Verified date: October 2022
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Pump settings
Alteration in the pump setting prior to exercise commencement

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen	Swansea University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of the occurrence of BG hypoglycaemic events	Comparison of the occurrence of blood glucose hypoglycaemic events before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of the depth of BG hypoglycaemic events	Comparison of the depth of blood glucose hypoglycaemic events before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of mean BG concentrations	Comparison of mean blood glucose concentrations before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of the standard deviation in BG concentrations	Comparison of the standard deviation in blood glucose concentrations before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of the coefficient of variation in BG concentrations	Comparison of the coefficient of variation in blood glucose concentrations before during and 1 hour after exercise	-90 min to +105min
Other	Comparison of the minimum BG concentration	Comparison of the minimum blood glucose concentration before during and 1 hour after exercise	-90 min to +105min
Other	Comparison of the maximum BG concentration	Comparison of the maximum blood glucose concentration before during and 1 hour after exercise	-90 min to +105min
Other	?BGexercise: Changes in BG concentrations during exercise	?BGexercise: Changes in blood glucose concentrations during exercise	0 min to +45 min
Other	?iGexercise: Changes in iG concentrations during exercise	?iGexercise: Changes in interstitial glucose concentrations during exercise	0 min to +45 min
Other	?BGfeeding: Change in BG concentrations after feeding	?BGfeeding: Change in blood glucose concentrations after feeding	-90 min to 0min
Other	?iGfeeding: Change in iG concentrations after feeding	?iGfeeding: Change in interstitial glucose concentrations after feeding	-90 min to 0min
Other	Comparison of TBR level 2 in iG values	Comparison of TBR level 2 in interstitial glucose values before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of TBR level 1 in iG values	Comparison of TBR level 1 in interstitial glucose values before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of TAR level 1 in iG values	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 +105 min
Other	Comparison of TAR level 2 in iG values	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 +105 min
Other	Comparison of mean iG concentrations	Comparison of mean interstitial glucose concentrations before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of the standard deviation in iG concentrations	Comparison of the standard deviation in interstitial glucose concentrations before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of the coefficient of variation in iG concentrations	Comparison of the coefficient of variation in interstitial glucose concentrations before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of the minimum iG concentration	Comparison of the minimum interstitial glucose concentration before during and 1 hour after exercise	-90 min to +105 min
Other	Comparison of the maximum iG concentration	Comparison of the maximum interstitial glucose concentration before during and 1 hour after exercise	-90 min to +105 min
Primary	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	-90 min to +105 min