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

prof dr Pieter Gillard

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Device: Diary app

Device: Activity tracker and chest strap

Study type

Interventional

Funder types

Other

Identifiers

NCT05670366

S64550

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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