Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring

The purpose of this project is to investigate whether the glucose response in type 1 diabetes patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated standardized test sessions that include physical activity.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Continuous Glucose Monitoring Diabetes Mellitus Endocrine System Diseases Exercise Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 1 diabetes with a diabetes duration of at least 2 years
age 18-60 years (inclusive)
given informed consent
exercises (at least 30 minutes intentional exercise where participants feel exhausted) one or more times a week
participants agree to use CGM correctly

Exclusion criteria

pregnancy
exercising at a high level (five or more times a week with high intensity)
treatment with prednisolone or less than a month ago contestant has been treated with prednisolone
treatment with beta blockers
Abuse of alcohol / drugs

Treatment and study plan

Blood glucose measured using CGM during standardized physical activity

Behavioral

Standardized exercise on bicycle at 70% of the participants work capacity for ½ hour.

Primary outcomes

Blood glucose response measured with CGM

Time frame: 3 identical testing sessions throughout 3 weeks

The participants will be tested on the research facility on a hospital in Denmark

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Oct 21, 2016
Registry last updated: Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed