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

NCT ID: NCT05670366

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2023-07-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Physically active participants

There is only one study arm, namely all participants are subjected to the same interventions.

Group Type: OTHER

Activity tracker and chest strap

Intervention Type: DEVICE

During the study, the participants will be asked to wear a commercially-available activity tracker during day and night, and a chest strap during sport activities to collect data on physical activity (type, intensity and duration of activity).

Diary app

Intervention Type: DEVICE

During the study, the participants will be asked to log the ingestion of carbohydrates, periods and type of physical activity, feelings (e.g. sick, stress, ...) in a diary app.

Interventions

Activity tracker and chest strap

During the study, the participants will be asked to wear a commercially-available activity tracker during day and night, and a chest strap during sport activities to collect data on physical activity (type, intensity and duration of activity).

Intervention Type: DEVICE

Diary app

During the study, the participants will be asked to log the ingestion of carbohydrates, periods and type of physical activity, feelings (e.g. sick, stress, ...) in a diary app.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Colleges Leuven Limburg

UNKNOWN

Sponsor Role: collaborator

prof dr Pieter Gillard

OTHER

Sponsor Role: lead

Responsible Party

prof dr Pieter Gillard

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pieter Gillard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S64550

Identifier Type: -

Identifier Source: org_study_id