The Integration of Physical Activity Into the Clinical Decision Process of People with Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Activity tracker and chest strap; Device: Diary app

• Registration Number: NCT05670366
• Lead Sponsor: prof dr Pieter Gillard

Brief Summary

Every person with type 1 diabetes needs personalized advice to integrate physical activity into daily diabetes management. The purpose of this study is to collect data on food intake, physical activity, glucose levels and insulin delivery from people with type 1 diabetes who are physically active. At least 25 people with type 1 diabetes will be asked to perform 25 sports activities of at least half an hour, wear an activity tracker (day and night) and chest strap (during sports activities), and log data on food intake, periods and type of physical activity, and feelings (e.g., sick, stress) in a diary app. Diabetes data such as insulin administration and sensor data will be collected through diabetes management platforms. The primary endpoint involves a database containing data on glucose, insulin administration, physical activity, and food intake of people with type 1 diabetes for statistical analyses and visualizations regarding the relationship between physical activity and blood glucose response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-29
• Study Start: 2022-09-26
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2023-01-04
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Signed informed consent
• 18-80 years old
• Type 1 diabetes ≥1 year
• Using a CGM for more than 6 months
• Using insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 months
• No use of adjunctive therapies, such as SGLT2-inhibitors or GLP-1 analogues
• No known diabetic gastroparesis
• HbA1c of the last two diabetes consultations are both <10%
• Being physically active at least twice a week on two separate days for 30 consecutive minutes

Exclusion Criteria

• Age <18 years or >80 years
• People with type 2 diabetes, people with secondary diabetes
• Begin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusion
• Not using CGM prior to inclusion
• Known diabetic gastroparesis
• HbA1c > 10% during one of the last two diabetes consultations
• Not willing to use an activity tracker, the diary app or the food app
• Not being physically active on a regular basis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physically active participants	Activity tracker and chest strap	There is only one study arm, namely all participants are subjected to the same interventions.
Physically active participants	Diary app	There is only one study arm, namely all participants are subjected to the same interventions.

Primary Outcome Measures

Name	Time	Method
Database which contains insulin data (insulin dose over time) retrieved from diabetes management platforms.	Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (intensity of activity) retrieved from the activity tracker and chest strap.	Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (timing of food) retrieved from the diary app.	Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains glucose data (glycemic values over time) retrieved from diabetes management platforms.	Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (amount of food in grams) retrieved from the diary app.	Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (type of activity) retrieved from the activity tracker and chest strap.	Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (duration of activity) retrieved from the activity tracker and chest strap.	Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (type of food) retrieved from the diary app.	Through study completion (after 25 sport activities), an average of 6 weeks

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium