Clinical trial NCT06469593: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Official title: AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Closed-loop insulin pump
Automated insulin delivery
AID systems
Artificial pancreas
Type 1 Diabetes
T1D
Sleep
Cognition
Cardiovascular risk
Inflammation
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2024-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label study comparing type-1 diabetes patients receiving usual treatment, with patients transitioning to AID systems
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Difference in change from baseline to study end in sleep efficiency between the two groups.
timeFrame: Baseline and week 18
Secondary outcomes:
measure: Total sleep duration
timeFrame: Baseline and week 18
measure: Time in sleep stages
timeFrame: Baseline and week 18
measure: Time in sleep stages
timeFrame: Baseline and week 18
measure: Sleep latency
timeFrame: Baseline and week 18
measure: Waking after sleep onset
timeFrame: Baseline and week 18
measure: 24-hour blood pressure
timeFrame: Baseline and week 18
measure: Heart rate variability
timeFrame: Baseline and week 18
measure: Heart rate variability
timeFrame: Baseline and week 18
measure: Heart rate variability
timeFrame: Baseline and week 18
measure: Heart rate variability
timeFrame: Baseline and week 18
measure: Cognitive function
timeFrame: Baseline and week 18
measure: Cognitive function
timeFrame: Baseline and week 18
measure: Cognitive function
timeFrame: Baseline and week 18
measure: Cognitive function
timeFrame: Baseline and week 18
measure: Inflammatory markers
timeFrame: Baseline and week 18
measure: Hypoglycaemia Fear Survey scores
timeFrame: Baseline and week 18
measure: Diabetes Distress Scale scores
timeFrame: Baseline and week 18
measure: Pittsburgh Sleep Quality Index scores
timeFrame: Baseline and week 18
measure: EuroQol 5-Domain scores
timeFrame: Baseline and week 18
measure: 5-item World Health Organization Well-Being Index (WHO-5) scores
timeFrame: Baseline and week 18
measure: Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores
timeFrame: Baseline and week 18
measure: Sleep efficiency
timeFrame: Baseline and week 18
measure: Wake time after sleep onset
timeFrame: Baseline and week 18
Other outcomes:
measure: HbA1c
timeFrame: Baseline and week 18
measure: Time with glucose values in range of 3.9 -10.0 mmol/L
timeFrame: Baseline and week 18
measure: Time with glucose values < 3.9 mmol/l
timeFrame: Baseline and week 18
measure: Time with glucose values < 3.0 mmol/l
timeFrame: Baseline and week 18
measure: Time with glucose values > 10.0 mmol/l
timeFrame: Baseline and week 18
measure: Time with glucose values > 13.9 mmol/l
timeFrame: Baseline and week 18
measure: Sensor glucose
timeFrame: Baseline and week 18
measure: Glucose coefficient of variation
timeFrame: Baseline and week 18
measure: Time with rapid glucose change (> 1,5 mmol/l/15 min)
timeFrame: Baseline and week 18
measure: Bodyweight
timeFrame: Baseline and week 18
measure: BMI standard deviation scores
timeFrame: Baseline and week 18
measure: Total daily insulin dose
timeFrame: Baseline and week 18
measure: Total daily carbohydrate intake
timeFrame: Baseline and week 18
measure: Hypoglycaemia awareness status
timeFrame: Baseline and week 18
measure: Hypoglycaemia awareness status
timeFrame: Baseline and week 18
measure: Hypoglycaemia awareness status
timeFrame: Baseline and week 18
measure: Energy expenditure
timeFrame: Baseline and week 18
measure: Physical activity level
timeFrame: Baseline and week 18
measure: Number of severe hypoglycaemia events
timeFrame: Baseline and week 18
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
state: Greater Copenhagen
city: Aarhus
country: Denmark
facility: Steno Diabetes Center Aarhus
city: Silkeborg
country: Denmark
facility: Diagnostisk Center, Regionshospitalet Silkeborg
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Kirsten Nørgaard, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Kurt Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: