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

NCT05134025 | Completed

• 1 other identifier: SMART A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (20)

• Comparison of the occurrence of BG hypoglycaemic events

  -90 min to +105 min

• Comparison of the depth of BG hypoglycaemic events

  -90 min to +105 min

• Comparison of mean BG concentrations

  -90 min to +105 min

Study Arms (3)

SMART A1

EXPERIMENTAL

A full dose of meal-time insulin with announced exercise immediately prior to commencement

Other: Pump settings

SMART A2

EXPERIMENTAL

a 25% dose reduction in meal-time insulin with exercise announcement 90-minutes prior to commencement

Other: Pump settings

SMART A3

EXPERIMENTAL

a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement

Other: Pump settings

Interventions

Pump settings OTHER

Alteration in the pump setting prior to exercise commencement

SMART A1; SMART A2; SMART A3

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. Automated Insulin Delivery Around Exercise in Adults with Type 1 Diabetes: A Pilot Randomized Controlled Study. Diabetes Technol Ther. 2023 Jul;25(7):476-484. doi: 10.1089/dia.2023.0009. Epub 2023 May 8.

  PMID: 37053529 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

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

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

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 24, 2021
• Study Start: September 14, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

DK (1)