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NCT Number: NCT05670366

The Integration of Physical Activity Into the Clinical Decision Process of 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Activity tracker and chest strap

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

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

prof dr Pieter Gillard

Other

Collaborators

  • University Colleges Leuven Limburg

Registry information

Official study title

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

Acronym: ENHANCED1

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2023
Registry last updated
Mar 17, 2025

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.

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