The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems

NCT05619198 | Unknown

• 1 other identifier: MODE2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (PA) in response to acute moderate intensity continous exercise (MICE) and high intensity interval exercise (HIIE) among adolescents with type 1 diabetes (T1D) using automated insulin delivery (AID) systems (MiniMed 780G and Tandem Control-IQ). Methods: This study will be a two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities among a total of 24 age-, sex-, and insulin-dose-matched adolescents with T1D (12 using MiniMed 780G and 12 using Tandem Control-IQ). Endpoint: The primary endpoint is sensor-derived time in range (3.9 mmol/L-10.0 mmol/L) around exercise

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in sensor-derived time in range (3.9-10.0 mmol/L) during and after a bout of exercise

  Percentage

  T = 0 to T = +120 (120 minutes)

Secondary Outcomes (32)

• Number of hypo- (<3.9 mmol/L) and hyperglycemic (>10.0 mmol/L) occurrences during exercise session as measured by sensor and plasma sampling

  T = 0 to T = +45 (45 minutes)

• Percentage of time spent below (<3.9 mmol/L), in (3.9-10.0 mmol/L) and above (>10.0 mmol/L) range during in-clinic phase, measured by sensor and plasma sampling

  T= -60 minutes to T= +120 minutes (3 hours)

• Percentage of time spent below (<3.9 mmol/L), in (3.9-10.0 mmol/L) and above (>10.0 mmol/L) range during home-phase, measured by glucose sensor

  24 hours

• Glycemic variability as coefficient of variation, measured by sensor during in-clinic phase

  T= -60 minutes to T= +120 minutes (3 hours)

• Glycemic variability as coefficient of variation, measured by plasma sampling during in-clinic phase

  T= -60 minutes to T= +120 minutes (3 hours)

Study Arms (2)

High Intensity Interval Exercise

ACTIVE COMPARATOR

Plasma and sensor glucose is monitored before, during and after a bout of high intensity interval exercise

Behavioral: High Intensity Interval Exercise

Moderate Intensity Continous Exercise

ACTIVE COMPARATOR

Plasma and sensor glucose is monitored before, during and after a bout of moderate intensity continous exercise

Behavioral: Moderate Intensity Continous Exercise

Interventions

High Intensity Interval Exercise BEHAVIORAL

High Intensity Interval Exercise: * 5 minutes resting phase @ 0 watts. * 5-minute warm up phase @ 20 watts. * 40 minutes of interval work consisting of eight bouts of 1-minute cycling at a power output corresponding to \~85% of VO2max interspersed with 4-minute recovery periods at 20 watts. * 5 minutes resting phase @ 0 watts.

High Intensity Interval Exercise

Moderate Intensity Continous Exercise BEHAVIORAL

Moderate Intensity Continous Exercise: * 5 minutes resting phase @ 0 watts. * 5-minute warm up phase @ 20 watts. * 40 minutes of MICE 65% VO2max. * 5 minutes resting phase @ 0 watts.

Moderate Intensity Continous Exercise

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 13-17 years old
• Type 1 diabetes \> 1 year
• Use of Tandem t:slim X2 Control-IQ or Medtronic MiniMed 780G with connected continous glucose monitor \> 3 months
• HbA1c below 75 mmol/L

You may not qualify if:

• Use of anti-diabetic medicine other than insulin
• Breastfeeding, pregnancy or planning to become pregnant
• Lack of compliance with key study procedures at the discretion of the investigator

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emilie Lindkvist, MD

  Steno Diabetes Center Copenhagen, Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Lindkvist, MD

CONTACT

+45 20187762; emilie.lindkvist@regionh.dk

Kirsten Nørgaard

CONTACT

kirsten.noergaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities in adolescents with type 1 diabetes

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: November 16, 2022
• Study Start: December 19, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 14, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)