Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: Automated insuling delivery system
- Registration Number
- NCT06469593
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Children with type 1 diabetes (intervention) Automated insuling delivery system Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly Adults with type 1 diabetes (intervention) Automated insuling delivery system -
- Primary Outcome Measures
Name Time Method Difference in change from baseline to study end in sleep efficiency between the two groups. Baseline and week 18 Measured by HomeSleepTest for 3 consecutive days. Expressed in percentage.
- Secondary Outcome Measures
Name Time Method Time in sleep stages Baseline and week 18 As measured by HomeSleepTest for 3 consequtive days. Expressed in percentages.
Cognitive function Baseline and week 18 Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Stop Signal Task test for the adult population only.
Inflammatory markers Baseline and week 18 Defined in fold changes to expression of IL-1β, IL-6, IL-8, TNF-α, MCP-1, VEGF-α, CRP, ICAM-1, V-CAM-1, CRP. Assessed using multiplex ELISA analyses with MesoScale V-Plex and S-Plex plates.
Hypoglycaemia Fear Survey scores Baseline and week 18 Possible scores between 0-44, higher scores mean more fear of hypoglycemia.
Diabetes Distress Scale scores Baseline and week 18 Possible scores between 7-42, higher scores mean more diabetes distress.
Pittsburgh Sleep Quality Index scores Baseline and week 18 Measured for adults only. Possible scores between 0-21, higher scores means more severe sleep issues.
Sleep latency Baseline and week 18 As measured by HomeSleepTest and ActiGraph for 3 consequtive days.Expressed in minutes
Waking after sleep onset Baseline and week 18 As measured by HomeSleepTest and Actigraph for 3 consequtive days. Expressed in minutes
24-hour blood pressure Baseline and week 18 Measured using SpaceLabs Ontrak. Expressed in mmHg, SBP, DBP and MAP means and differences at day/nighttime. Presence of nighttime dipping (defined as MAP reduction of 10% or more). Difference in dat day- and nighttime defined as time asleep measured by HST.
Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores Baseline and week 18 Measured for children
Sleep efficiency Baseline and week 18 Measured in percentages, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries.
Total sleep duration Baseline and week 18 As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.
Heart rate variability Baseline and week 18 Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as frequency-domain distribution relative power in percentage.
EuroQol 5-Domain scores Baseline and week 18 For adults the 5 Likert scale (5Q-5D-5L) will be used. For children the Young scale (5Q-5D-Y) scale will be used.
Wake time after sleep onset Baseline and week 18 Measured in minutes, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries.
5-item World Health Organization Well-Being Index (WHO-5) scores Baseline and week 18 Possible scores between 0-100. Lower scores means worse well-being.
Trial Locations
- Locations (3)
Steno Diabetes Center Aarhus
🇩🇰Aarhus, Denmark
Diagnostisk Center, Regionshospitalet Silkeborg
🇩🇰Silkeborg, Denmark
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Greater Copenhagen, Denmark