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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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:
Participants will, at baseline and after 4 months:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with type 1 diabetes (intervention) | Experimental |
| |
| Adults with type 1 diabetes (control) | No Intervention | ||
| Children with type 1 diabetes (intervention) | Experimental | Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly |
|
| Children with type 1 diabetes (control) | No Intervention | Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated insuling delivery system | Device | Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria (Adults):
Inclusion Criteria (Children):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Z Sørensen, MD | Contact | 26836584 | +45 | michael.zaucha.soerensen.02@regionh.dk |
| Natalie V Olesen, MD | Contact | 31627437 | +45 | nataol@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kirsten Nørgaard, MD, Prof. | Steno Diabetes Center Copenhagen | Principal Investigator |
| Kurt Kristensen, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Recruiting | Herlev | Greater Copenhagen | 2730 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized, open-label study comparing type-1 diabetes patients receiving usual treatment, with patients transitioning to AID systems
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|
| 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 |
| 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 |
| Steno Diabetes Center Aarhus | Recruiting | Aarhus | 8200 | Denmark |
|
| Diagnostisk Center, Regionshospitalet Silkeborg | Recruiting | Silkeborg | 8200 | Denmark |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |