The Integration of Physical Activity Into the Clinical Decision Process of People with Type 1 Diabetes (ENHANCED1)

March 12, 2025 updated by: prof dr Pieter Gillard

Proof-of-concept Study for the Integration of Physical Activity Into the Clinical Decision Process of Physically Active People with Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physically active participants
There is only one study arm, namely all participants are subjected to the same interventions.
Device: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Database which contains insulin data (insulin dose over time) retrieved from diabetes management platforms.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
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.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
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.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
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.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
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.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
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.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
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.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
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.
Time Frame: Through study completion (after 25 sport activities), an average of 6 weeks
Through study completion (after 25 sport activities), an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

prof dr Pieter Gillard

Collaborators

University Colleges Leuven Limburg

Investigators

  • Principal Investigator: Pieter Gillard, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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