Type 1 Diabetes
Conditions
Keywords
Physical activity, Artificial intelligence
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.
Interventions
DEVICEActivity 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).
DEVICEDiary 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.
Sponsors
University Colleges Leuven Limburg
prof dr Pieter Gillard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed