Automated insulin delivery for type 1 diabetes
AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
This study is testing if using automated insulin delivery systems can improve sleep quality and heart health for people with type 1 diabetes compared to their usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 3 sites (Herlev, Greater Copenhagen and 2 other locations) |
| Trial ID | NCT06469593 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of automated insulin delivery (AID) systems on sleep quality and cardiovascular risk factors in individuals with type 1 diabetes. Participants, both children and adults, will be randomized to either receive AID treatment or continue with their usual care, which includes multiple daily injections or sensor-augmented pumps. The study will measure sleep efficiency and cardiovascular markers over a four-month period using various assessments, including blood and urine samples. The goal is to determine if AID can provide significant health benefits beyond glucose control.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 7 years and older with a diagnosis of type 1 diabetes and prior use of continuous glucose monitoring.
Not a fit: Patients who have used automated insulin delivery systems prior to the study or those with severe cardiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and reduced cardiovascular risks for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with automated insulin delivery systems, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Adults): * Age ≥18 years * Type 1 diabetes ≥3 years * CGM or intermittently scanned CGM (isCGM) use ≥6 months * Approval from the responsible health care provider (HCP) to start AID * Specific AID system chosen ahead of screening after participant has been thoroughly informed Inclusion Criteria (Children): * Age 7-17 years * Type 1 diabetes ≥6 months * CGM or isCGM use ≥6 months * Approval from the responsible HCP to start AID * Specific AID system chosen ahead of screening after participant has been thoroughly informed Exclusion Criteria: * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start * Use of commercial or open-source AID systems prior to study participation * Daily use of paracetamol (acetaminophen) * Breast-feeding, pregnancy or planning to become pregnant within 4 months * Alcohol or drug abuse * Severe cardiac disease * Retinopathy contraindicating HbA1c \<53 mmol/mol * Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the person unsuitable for study participation * Lack of compliance with key study procedures at the discretion of the investigator
Where this trial is running
Herlev, Greater Copenhagen and 2 other locations
- Steno Diabetes Center Copenhagen — Herlev, Greater Copenhagen, Denmark (Recruiting)
- Steno Diabetes Center Aarhus — Aarhus, Denmark (Recruiting)
- Diagnostisk Center, Regionshospitalet Silkeborg — Silkeborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Kirsten Nørgaard, MD, Prof. — Steno Diabetes Center Copenhagen
- Study coordinator: Michael Z Sørensen, MD
- Email: michael.zaucha.soerensen.02@regionh.dk
- Phone: 26836584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.