Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
NCT Number: NCT06469593
Acronym: AID-BEYOND
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 1
Interventions: DEVICE: Automated insuling delivery system
Sponsor: Steno Diabetes Center Copenhagen
Collaborators: Aarhus University Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2027-12-31
Locations: Steno Diabetes Center Copenhagen, Herlev, Greater Copenhagen, 2730, Denmark|Steno Diabetes Center Aarhus, Aarhus, 8200, Denmark|Diagnostisk Center, Regionshospitalet Silkeborg, Silkeborg, 8200, Denmark

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.

Primary Outcome Measures: Difference in change from baseline to study end in sleep efficiency between the two groups., Measured by HomeSleepTest for 3 consecutive days. Expressed in percentage., Baseline and week 18
Secondary Outcome Measures: Total sleep duration, As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes., Baseline and week 18|Time in sleep stages, As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes., Baseline and week 18|Time in sleep stages, As measured by HomeSleepTest for 3 consequtive days. Expressed in percentages., Baseline and week 18|Sleep latency, As measured by HomeSleepTest and ActiGraph for 3 consequtive days.Expressed in minutes, Baseline and week 18|Waking after sleep onset, As measured by HomeSleepTest and Actigraph for 3 consequtive days. Expressed in minutes, Baseline and week 18|24-hour blood pressure, 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., Baseline and week 18|Heart rate variability, Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as standard deviation of NN intervals in milliseconds., Baseline and week 18|Heart rate variability, Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as root mean square of successive RR interval differences (rMSSD) in milliseconds., Baseline and week 18|Heart rate variability, Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as frequency-domain distribution absolute power in milliseconds squared., Baseline and week 18|Heart rate variability, Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as frequency-domain distribution relative power in percentage., Baseline and week 18|Cognitive function, Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Rapid Visual Information Processing test for both the adult and pediatric population., Baseline and week 18|Cognitive function, Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Delayed Matching to Sample test for both the adult and pediatric population., Baseline and week 18|Cognitive function, Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Spatial Working Memory test for the adult population only., Baseline and week 18|Cognitive function, Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Stop Signal Task test for the adult population only., Baseline and week 18|Inflammatory markers, 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., Baseline and week 18|Hypoglycaemia Fear Survey scores, Possible scores between 0-44, higher scores mean more fear of hypoglycemia., Baseline and week 18|Diabetes Distress Scale scores, Possible scores between 7-42, higher scores mean more diabetes distress., Baseline and week 18|Pittsburgh Sleep Quality Index scores, Measured for adults only. Possible scores between 0-21, higher scores means more severe sleep issues., Baseline and week 18|EuroQol 5-Domain scores, For adults the 5 Likert scale (5Q-5D-5L) will be used. For children the Young scale (5Q-5D-Y) scale will be used., Baseline and week 18|5-item World Health Organization Well-Being Index (WHO-5) scores, Possible scores between 0-100. Lower scores means worse well-being., Baseline and week 18|Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores, Measured for children, Baseline and week 18|Sleep efficiency, Measured in percentages, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries., Baseline and week 18|Wake time after sleep onset, Measured in minutes, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries., Baseline and week 18
Other Outcome Measures: HbA1c, Baseline and week 18|Time with glucose values in range of 3.9 -10.0 mmol/L, Measured in percentage., Baseline and week 18|Time with glucose values < 3.9 mmol/l, Measured in percentage., Baseline and week 18|Time with glucose values < 3.0 mmol/l, Measured in percentage., Baseline and week 18|Time with glucose values > 10.0 mmol/l, Measured in percentage., Baseline and week 18|Time with glucose values > 13.9 mmol/l, Measured in percentage., Baseline and week 18|Sensor glucose, Measured as mmol/l with mean values and standard deviations, Baseline and week 18|Glucose coefficient of variation, Measured in percentage, Baseline and week 18|Time with rapid glucose change (> 1,5 mmol/l/15 min), Measured in percentage., Baseline and week 18|Bodyweight, Measured in kilograms., Baseline and week 18|BMI standard deviation scores, Measured in the pediatric population., Baseline and week 18|Total daily insulin dose, Measured in IE and assessed by 2-week insulin pump data downloads, Baseline and week 18|Total daily carbohydrate intake, Measured in grams and assessed by 2-week insulin pump data downloads, Baseline and week 18|Hypoglycaemia awareness status, Assessed by the Gold questionaire. Possible scores between 1-7 with 7 being worst hypoglycemia awareness., Baseline and week 18|Hypoglycaemia awareness status, Assessed by the Clarke questionaire. Possible scores between 0-7 with 7 being worst hypoglycemia awareness., Baseline and week 18|Hypoglycaemia awareness status, Assessed by the Pedersen-Bjergaard questionaire. Possible outcomes are "Aware", "Impaired" and "Unaware"., Baseline and week 18|Energy expenditure, Measured in kcal and assessed with 7 days of ActiGraph data., Baseline and week 18|Physical activity level, Categorized as sedentary, light and moderate-to-vigorous levels, assessed with 7 days of ActiGraph data., Baseline and week 18|Number of severe hypoglycaemia events, Expressed in diffence in number of events from baseline to end. Defined as cognitive impairment requiring external assistance for recovery., Baseline and week 18