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

Type 1 Diabetes Clinical Trial

— ENHANCED1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670366
• Other study ID #: S64550
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Pieter Gillard, MD, PhD
• Phone: 016 340615
• Email: pieter.gillard[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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).
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
prof dr Pieter Gillard	University Colleges Leuven Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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