Actively Recruiting
Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Led by Steno Diabetes Center Copenhagen · Updated on 2024-06-21
200
Participants Needed
3
Research Sites
184 weeks
Total Duration
On this page
Sponsors
S
Steno Diabetes Center Copenhagen
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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? * Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability (HRV), blood pressure and inflammatory markers? * Researchers will compare AID systems to usual treatment, including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison. Participants will be randomized 1:1 to either start AID treatment or to continue their usual care. The study will be open label. Participants will, at baseline and after 4 months: * Have taken blood and urine samples to measure metabolic and inflammatory parameters * Perform digital cognitive testing using the CANTAB software * Fill out questionnaires related to quality of life, fear of hypoglycemia, hypoglycemia awareness, eating habits and sleep quality * Wear a blinded CGM for 10 days * Monitor sleep at home using the HomeSleepTest for 3 consecutive nights * Wear a Holter monitor for 24 hours to determine HRV parameters * Measure blood pressure for 24 hours at 30 min intervals * Wear an ActiGraph for 7 days to assess sleep and activity, supported by daily electronic sleep diaries Participants randomized to AID treatment will receive education in the use of the systems. Virtual follow-up visits are scheduled at week 1, 5 and 9 for both control and intervention groups during the study, following baseline examinations.
CONDITIONS
Official Title
Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with type 1 diabetes for 3 years or more
- Using continuous glucose monitoring (CGM) or intermittently scanned CGM for at least 6 months
- Approval from a healthcare provider to start automated insulin delivery (AID)
- Chosen specific AID system before screening after being fully informed
- Children aged 7 to 17 years
- Diagnosed with type 1 diabetes for at least 6 months
- Using CGM or intermittently scanned CGM for at least 6 months
- Approval from a healthcare provider to start AID
- Chosen specific AID system before screening after being fully informed
You will not qualify if you...
- Use of anti-diabetic medicines other than insulin, corticosteroids, or drugs affecting glucose metabolism during the study or within 30 days before starting
- Prior use of commercial or open-source AID systems
- Daily use of paracetamol (acetaminophen)
- Breastfeeding, pregnancy, or planning pregnancy within 4 months
- Alcohol or drug abuse
- Severe heart disease
- Retinopathy that prevents HbA1c below 53 mmol/mol
- Other medical or psychological conditions making participation unsuitable
- Lack of compliance with important study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Steno Diabetes Center Copenhagen
Herlev, Greater Copenhagen, Denmark, 2730
Actively Recruiting
2
Steno Diabetes Center Aarhus
Aarhus, Denmark, 8200
Actively Recruiting
3
Diagnostisk Center, Regionshospitalet Silkeborg
Silkeborg, Denmark, 8200
Actively Recruiting
Research Team
M
Michael Z Sørensen, MD
CONTACT
N
Natalie V Olesen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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