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New treatment option for Diabetes Mellitus, Type 1
Official title Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
ClinicalTrials.gov ID: NCT06469593
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine if transitioning to automated insulin delivery (AID) systems, can improve objectively measured sleep quality and quantity and alleviate cardiovascular risk factors in both children and adults diagnosed with type 1 diabetes. The main questions it aims to answer are: Does the intervention improve sleep efficiency as measured by the HomeSleepTest, EEG based device, 4 months after initiation?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 and older
You may be able to join if
- (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
You likely can't join if
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30...
- 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
See the full eligibility 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 (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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Greater Copenhagen, Denmark
- Aarhus, Denmark
- Silkeborg, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Greater Copenhagen, Denmark; Aarhus, Denmark; Silkeborg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.