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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06469593
Other study ID # H-23074743
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date December 31, 2027

Study information

Verified date June 2024
Source Steno Diabetes Center Copenhagen
Contact Michael Z Sørensen, MD
Phone 26836584
Email michael.zaucha.soerensen.02@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 7 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Automated insuling delivery system
Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS

Locations

Country Name City State
Denmark Steno Diabetes Center Aarhus Aarhus
Denmark Steno Diabetes Center Copenhagen Herlev Greater Copenhagen
Denmark Diagnostisk Center, Regionshospitalet Silkeborg Silkeborg

Sponsors (2)

Lead Sponsor Collaborator
Steno Diabetes Center Copenhagen Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other HbA1c Baseline and week 18
Other Time with glucose values in range of 3.9 -10.0 mmol/L Measured in percentage. Baseline and week 18
Other Time with glucose values < 3.9 mmol/l Measured in percentage. Baseline and week 18
Other Time with glucose values < 3.0 mmol/l Measured in percentage. Baseline and week 18
Other Time with glucose values > 10.0 mmol/l Measured in percentage. Baseline and week 18
Other Time with glucose values > 13.9 mmol/l Measured in percentage. Baseline and week 18
Other Sensor glucose Measured as mmol/l with mean values and standard deviations Baseline and week 18
Other Glucose coefficient of variation Measured in percentage Baseline and week 18
Other Time with rapid glucose change (> 1,5 mmol/l/15 min) Measured in percentage. Baseline and week 18
Other Bodyweight Measured in kilograms. Baseline and week 18
Other BMI standard deviation scores Measured in the pediatric population. Baseline and week 18
Other Total daily insulin dose Measured in IE and assessed by 2-week insulin pump data downloads Baseline and week 18
Other Total daily carbohydrate intake Measured in grams and assessed by 2-week insulin pump data downloads Baseline and week 18
Other Hypoglycaemia awareness status Assessed by the Gold questionaire. Possible scores between 1-7 with 7 being worst hypoglycemia awareness. Baseline and week 18
Other Hypoglycaemia awareness status Assessed by the Clarke questionaire. Possible scores between 0-7 with 7 being worst hypoglycemia awareness. Baseline and week 18
Other Hypoglycaemia awareness status Assessed by the Pedersen-Bjergaard questionaire. Possible outcomes are "Aware", "Impaired" and "Unaware". Baseline and week 18
Other Energy expenditure Measured in kcal and assessed with 7 days of ActiGraph data. Baseline and week 18
Other Physical activity level Categorized as sedentary, light and moderate-to-vigorous levels, assessed with 7 days of ActiGraph data. Baseline and week 18
Other 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
Primary 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 Total sleep duration As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes. Baseline and week 18
Secondary Time in sleep stages As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes. Baseline and week 18
Secondary Time in sleep stages As measured by HomeSleepTest for 3 consequtive days. Expressed in percentages. Baseline and week 18
Secondary Sleep latency As measured by HomeSleepTest and ActiGraph for 3 consequtive days.Expressed in minutes Baseline and week 18
Secondary Waking after sleep onset As measured by HomeSleepTest and Actigraph for 3 consequtive days. Expressed in minutes Baseline and week 18
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Inflammatory markers Defined in fold changes to expression of IL-1ß, IL-6, IL-8, TNF-a, MCP-1, VEGF-a, CRP, ICAM-1, V-CAM-1, CRP. Assessed using multiplex ELISA analyses with MesoScale V-Plex and S-Plex plates. Baseline and week 18
Secondary Hypoglycaemia Fear Survey scores Possible scores between 0-44, higher scores mean more fear of hypoglycemia. Baseline and week 18
Secondary Diabetes Distress Scale scores Possible scores between 7-42, higher scores mean more diabetes distress. Baseline and week 18
Secondary 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
Secondary 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
Secondary 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
Secondary Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores Measured for children Baseline and week 18
Secondary Sleep efficiency Measured in percentages, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries. Baseline and week 18
Secondary 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
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