The SMART B Exercise Study :''The SMART Study''

Hypoglycemia 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: NCT05133765
• Other study ID #: SMART B
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: October 7, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 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

• Hypoglycemia

Intervention

Device:
• Insulin pump
Alterations in insulin pump therapy or carbohydrate consumption

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 maximum BG concentration	Comparison of the maximum blood glucose concentration before, during and for 1 hour after physical exercise	-90 minutes to +105 minutes
Other	Comparison of the minimum BG concentration	Comparison of the minimum blood glucose concentration before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Other	Comparison of standard deviation in BG concentrations	Comparison of standard deviation in blood glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 min to +105 minutes
Other	Comparison of mean BG concentrations	Comparison of mean blood glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Other	Comparison of the depth of BG hypoglycaemic events	Comparison of the depth of blood glucose hypoglycaemic events before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Other	Comparison of the occurrence of BG hypoglycaemic events	Comparison of the occurrence of blood glucose hypoglycaemic events before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Other	?BGexercise: Comparison of the changes in BG during exercise	?BGexercise: Comparison of the changes in blood glucose during exercise before, during physical exercise (i.e., 0 min to +45min)	0 minutes to +45 minutes
Other	?iGexercise: Comparison of the changes in iG during exercise	?iGexercise: Comparison of the changes in interstitial glucose during exercise during physical exercise (i.e., 0 min to +45min)	0 minutes to +45 minutes
Other	?iGfeeding: Comparison of the changes in iG after feeding	?iGfeeding: Comparison of the changes in interstitial glucose after feeding before physical exercise (i.e., -90 min to 0 min)	-90 minutes to 0 minutes
Other	Comparison of TBR level 2 in iG values	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)	-90 minutes to +105 minutes
Other	Comparison of TBR level 1 in iG values	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)	-90 minutes to +105 minutes
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 for 1 hour after physical exercise (i.e., -0 min to +105min)	-90 minutes to +105 minutes
Other	Comparison of TAR level 2 in iG values	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)	-90 minutes to +105 minutes
Other	Comparison of mean iG concentrations	Comparison of mean interstitial glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Other	Comparison of the standard deviation in iG concentrations	Comparison of the standard deviation in interstitial glucose concentrations before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Other	Comparison of the coefficient of variation in iG concentrations	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)	-90 minutes to +105 minutes
Other	Comparison of the minimum iG concentration	Comparison of the minimum interstitial glucose concentration before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Other	Comparison of the maximum iG concentration	Comparison of the maximum interstitial glucose concentration before, during and for 1 hour after physical exercise (i.e., -90 min to +105min)	-90 minutes to +105 minutes
Primary	Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise	Comparison of the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise	0 minutes to +105 minutes
Secondary	To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise	To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise	0 minutes to +45 minutes