E10
Conditions
Interventions
Group 1: Observation of the effectiveness of insulin therapy using the Medtronic 780G system for automated insulin delivery (AID) during a 2-week diabetes camp.
This study is purely observational. As
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TIRAIDvsAID: Time in Range (TIR, 70-180 mg/dL) in % comparing different AID systems during the two-week summer camp. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of different AID systems during the two-week summer camp. - TITRAIDvsAID: Time in Tight Range (70-140 mg/dL) in % - TBR1AIDvsAID: Time Below Range 1 (TBR1, 180 mg/dL) in % - TAR2AIDvsAID: Time Above Range 2 (TAR2, >250 mg/dL) in % - CVAIDvsAID: Coefficient of Variance (CV) in % - MEANAIDvsAID: Mean Sensor Glucose in mg/dL - SDAIDvsAID: Standard Deviation of Mean Sensor Glucose in mg/dL - PROPTiRAIDvsAID: Proportion of participants with Time in Range (70–180 mg/dL) >70% - PROPTBR1AIDvsAID: Proportion of participants with Time Below Range 1 (TBR1 180 mg/dL) 250 mg/dL) 180 mg/dL) in % - TAR2AIDvsSuP: Time Above Range 2 (TAR2, >250 mg/dL) in %. - CVAIDvsSAP: Coefficient of Variance (CV) in % - MEANAIDvsSAP: Mean Sensor Glucose in mg/dL - SDAIDvsSAP: Standard Deviation of Mean Sensor Glucose in mg/dL - PROPTiRAIDvsSAP: Proportion of participants with Time in Range (70–180 mg/dL) >70% - PROPTBR1AIDvsSAP: Proportion of participants with Time Below Range 1 (TBR1 180 mg/dL) 250 mg/dL) <5% Associations between physical activity and glycemic outcomes, as well as sleep, comparing different AID systems among themselves and to sensor-assisted pump therapy during the two-week summer camp. The exact observation period for the primary and all secondary endpoints is defined from Day 1 of the camp at 18:00 to Day 15 at 08:00. In addition to the analysis over the full observation period (=2 weeks), endpoints will also be separately calculated for different times of day: Daytime (08:00 – 22:00) and Nighttime (22:00 – 08:00), or during various pre-determined exercise sessions with different levels of intensity. | — |
Countries
Austria
Contacts
Public ContactMartin Tauschmann
Medizinische Universität Wien
Outcome results
None listed