Effects of bolus insulin dose reduction on time in range during postprandial exercise with hybrid closed-loop insulin delivery (CamAPS FX) in children and adolescents with type 1 diabetes - A randomized controlled crossover trial

Not Applicable

• Conditions: E10; Type 1 diabetes mellitus

• Registration Number: DRKS00032442
• Lead Sponsor: niversität Bayreuth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Informed consent obtained (provided from parent or legal guardian).
- Male or female aged 8-17 years (both inclusive).
- Diagnosed with type 1 diabetes mellitus (>12 months).
- Use of a hybrid-closed loop insulin delivery system (mylife CamAPS FX).
- Body mass index between the 10th and 90th percentile for the respective sex and age for children in Germany.

Exclusion Criteria

- Simultaneous enrolment in any other study.
- Known or suspected hypersensitivity to trial products or related products.
- Receipt of any investigational medicinal product within 1 week prior to screening in this trial.
- Suffering from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influence the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and not adapted throughout the run of the trial. Furthermore, it does not excluded patients who have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific diet, e.g. gluten-free.
- Heart rate <35 beats per minute after resting for 5 min in supine position at screening
- Blood pressure outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic after resting for 5 min in supine position at screening (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives.
- Significant abnormal ECG at screening, as judged by the medical investigator.
- Any chronic (metabolic) disorder or severe disease besides type 1 diabetes mellitus which, in the opinion of the investigator, might jeopardize the participant’s safety or compliance with the protocol.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- Participant with mental incapacity or language barriers including inadequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, should not participate in the trial
- Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- t70-180: Time in range (TIR; 70-180 mg/dL) in min:sec during postprandial constant load cycling exercise in comparison of trial arms (superiority for 25% insulin bolus reduction).