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

NCT05133765 | Completed

• 1 other identifier: SMART B
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise

  0 minutes to +45 minutes

Other Outcomes (18)

• Comparison of the maximum BG concentration

  -90 minutes to +105 minutes

• Comparison of the minimum BG concentration

  -90 minutes to +105 minutes

• Comparison of standard deviation in BG concentrations

  -90 min to +105 minutes

Study Arms (3)

SMART B1 - Usual care insulin pump

EXPERIMENTAL

Usual care pump therapy arm with carbohydrate consumption before exercise

Device: Insulin pump

SMART B2 - Advanced hybrid closed loop insulin pump with carbohydrates before exercise

EXPERIMENTAL

Advanced hybrid closed loop therapy arm with carbohydrate consumption before exercise

Device: Insulin pump

SMART B3 - Advanced hybrid closed loop insulin pump with carbohydrates during exercise

EXPERIMENTAL

Advanced hybrid closed loop therapy arm with carbohydrate consumption during exercise

Device: Insulin pump

Interventions

Insulin pump DEVICE

Alterations in insulin pump therapy or carbohydrate consumption

SMART B1 - Usual care insulin pump; SMART B2 - Advanced hybrid closed loop insulin pump with carbohydrates before exercise; SMART B3 - Advanced hybrid closed loop insulin pump with carbohydrates during exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes ≥2 years.
• HbA1c;
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Swansea University: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Related Publications (2)

• McCarthy OM, Christensen MB, Kristensen KB, Schmidt S, Ranjan AG, Bain SC, Bracken RM, Norgaard K. Glycemia Around Exercise in Adults with Type 1 Diabetes Using Automated and Nonautomated Insulin Delivery Pumps: A Switch Pilot Trial. Diabetes Technol Ther. 2023 Apr;25(4):287-292. doi: 10.1089/dia.2022.0542. Epub 2023 Feb 16.

  PMID: 36724311 DERIVED

• McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, Ranjan AG, Nicholas C, Bain SC, Norgaard K, Bracken R. Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy. Diabetes Obes Metab. 2023 Mar;25(3):878-888. doi: 10.1111/dom.14938. Epub 2023 Jan 3.

  PMID: 36482870 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: Three period randomised cross-over clinical trial

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 24, 2021
• Study Start: September 14, 2021
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

DK (1)