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

NCT05670366 | Completed

• 1 other identifier: S64550
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

Physical activity; Artificial intelligence

Outcome Measures

Primary Outcomes (8)

• 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 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 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 (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 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 (timing of food) retrieved from the diary app.

  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 food intake data (type of food) retrieved from the diary app.

  Through study completion (after 25 sport activities), an average of 6 weeks

Study Arms (1)

Physically active participants

OTHER

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

Device: Activity tracker and chest strap; Device: Diary app

Interventions

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).

Physically active participants

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.

Physically active participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• 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

You may not qualify if:

• Age \<18 years or \>80 years
• People with type 2 diabetes, people with secondary diabetes
• 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

Sponsors & Collaborators

• prof dr Pieter Gillard: lead
• University Colleges Leuven Limburg: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Pieter Gillard, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: January 4, 2023
• Study Start: September 26, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 17, 2025

Record last verified: 2024-03

Locations

BE (1)