Automated insulin delivery for type 1 diabetes
Official title: AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Run by Steno Diabetes Center Copenhagen · NCT06469593 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 7 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 3 sites (Herlev, Greater Copenhagen and 2 other locations) |
| Status | Recruiting |
| Started | June 15, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | June 21, 2024 |
| Trial ID | NCT06469593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with automated insulin delivery systems, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes
This study tests whether using the Accu-Chek SmartGuide CGM with its Predict App can reduce fear of hypoglycemia and improve related behaviors and confidence in adults with type 1 or insulin-treated type 2 diabetes.
-
Tirzepatide for type 1 diabetes patients who are overweight or obese
This study tests whether tirzepatide can affect stomach emptying in adults with type 1 diabetes and overweight or obesity.
-
Oral insulin vs. subcutaneous insulin in adults with type 1 diabetes
This study tests an oral insulin tablet (SCD0503) against subcutaneous insulin and placebo to see how it behaves in the blood and helps control blood sugar in adults with type 1 diabetes.
-
Genetic risk score and progression to insulin in type 1 diabetes
This study tests whether a genetic risk score can predict which people with type 1 diabetes will need insulin progression over three years.
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Home-based use of an advanced hybrid closed-loop insulin pump with telemonitoring for adults with type 1 diabetes
This study tests whether starting an advanced hybrid closed-loop insulin pump at home, with online education and telemonitoring, is feasible and safe for adults with type 1 diabetes.
-
Diabetes multimorbidity and a voice diary app to help self-manage
This study tests whether the Fabla-diabetesMM audio diary app is feasible and helpful for older adults with type 1 or type 2 diabetes who also have additional chronic conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.