Prospective cohort study on the use of automated insulin delivery systems during a two-week summer camp for children with type 1 diabetes: an exploratory pilot study
- Conditions
- E10Type 1 diabetes mellitus
- Registration Number
- DRKS00034645
- Lead Sponsor
- Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
1) Diagnosed with type 1 diabetes
2) Signed consent form by a parent or legal guardian
3) Participation in the summer camp
4) Children aged 8-12 years
5) Use of an automated insulin delivery system or an insulin pump with CGM sensor without automation (sensor-augmented pump therapy, SAP) for at least one month at the start of the study.
Concurrent participation in another study.
2) Receipt of an investigational product within one week prior to screening in this study.
3) HbA1c > 11% (96 mmol/mol)
4) Any chronic (metabolic) disorder or serious illness other than type 1 diabetes that, in the opinion of the investigator, could jeopardize the safety of the participant or compliance with the protocol.
5) Participants with intellectual disabilities or language barriers, including inadequate understanding or cooperation, or those who, according to their primary care physician or the investigator, should not participate in the study.
6) Any condition that, in the opinion of the investigator, would impair the participant's ability to participate in the study or the evaluation of results.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TIRAIDvsAID: Time in Range (TIR, 70-180 mg/dL) in % comparing different AID systems during the two-week summer camp.
- Secondary Outcome Measures
Name Time Method