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NCT05670366
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
Conditions: Type 1 Diabetes
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 25
Sponsor: prof dr Pieter Gillard
Location: Belgium
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.
Eligibility Criteria
Inclusion Criteria:Signed informed consent18-80 years oldType 1 diabetes ≥1 yearUsing a CGM for more than 6 monthsUsing insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 monthsNo use of adjunctive therapies, such as SGLT2-inhibitors or GLP-1 analoguesNo known diabetic gastroparesisHbA1c of the last two diabetes consultations are both <10%Being physically active at least twice a week on two separate days for 30 consecutive minutesExclusion Criteria:Age <18 years or >80 yearsPeople with type 2 diabetes, people with secondary diabetesBegin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusionNot using CGM prior to inclusionKnown diabetic gastroparesisHbA1c > 10% during one of the last two diabetes consultationsNot willing to use an activity tracker, the diary app or the food appNot being physically active on a regular basis
Source: ClinicalTrials.gov (NCT05670366). StuddyBuddy aggregates publicly available trial information.