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NCT Number: NCT06469593

Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen, Herlev, Greater Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated insuling delivery system

Device

Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS

Other names: Closed-loop insulin pumps

Primary outcomes

  1. Difference in change from baseline to study end in sleep efficiency between the two groups.

    Time frame: Baseline and week 18

    Measured by HomeSleepTest for 3 consecutive days. Expressed in percentage.

Secondary outcomes

  1. Total sleep duration

    Time frame: Baseline and week 18

    As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.

  2. Time in sleep stages

    Time frame: Baseline and week 18

    As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.

  3. Time in sleep stages

    Time frame: Baseline and week 18

    As measured by HomeSleepTest for 3 consequtive days. Expressed in percentages.

  4. Sleep latency

    Time frame: Baseline and week 18

    As measured by HomeSleepTest and ActiGraph for 3 consequtive days.Expressed in minutes

  5. Waking after sleep onset

    Time frame: Baseline and week 18

    As measured by HomeSleepTest and Actigraph for 3 consequtive days. Expressed in minutes

  6. 24-hour blood pressure

    Time frame: 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.

  7. Heart rate variability

    Time frame: Baseline and week 18

    Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as standard deviation of NN intervals in milliseconds.

  8. Heart rate variability

    Time frame: Baseline and week 18

    Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as root mean square of successive RR interval differences (rMSSD) in milliseconds.

  9. Heart rate variability

    Time frame: Baseline and week 18

    Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as frequency-domain distribution absolute power in milliseconds squared.

  10. Heart rate variability

    Time frame: Baseline and week 18

    Measured using Bittium Faros 180 holter monitors for 24 hours. Measured as frequency-domain distribution relative power in percentage.

  11. Cognitive function

    Time frame: Baseline and week 18

    Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Rapid Visual Information Processing test for both the adult and pediatric population.

  12. Cognitive function

    Time frame: Baseline and week 18

    Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Delayed Matching to Sample test for both the adult and pediatric population.

  13. Cognitive function

    Time frame: Baseline and week 18

    Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Spatial Working Memory test for the adult population only.

  14. Cognitive function

    Time frame: Baseline and week 18

    Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) with the Stop Signal Task test for the adult population only.

  15. Inflammatory markers

    Time frame: 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.

  16. Hypoglycaemia Fear Survey scores

    Time frame: Baseline and week 18

    Possible scores between 0-44, higher scores mean more fear of hypoglycemia.

  17. Diabetes Distress Scale scores

    Time frame: Baseline and week 18

    Possible scores between 7-42, higher scores mean more diabetes distress.

  18. Pittsburgh Sleep Quality Index scores

    Time frame: Baseline and week 18

    Measured for adults only. Possible scores between 0-21, higher scores means more severe sleep issues.

  19. EuroQol 5-Domain scores

    Time frame: 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.

  20. 5-item World Health Organization Well-Being Index (WHO-5) scores

    Time frame: Baseline and week 18

    Possible scores between 0-100. Lower scores means worse well-being.

  21. Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores

    Time frame: Baseline and week 18

    Measured for children

  22. Sleep efficiency

    Time frame: Baseline and week 18

    Measured in percentages, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries.

  23. Wake time after sleep onset

    Time frame: Baseline and week 18

    Measured in minutes, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries.

Other outcomes

  1. HbA1c

    Time frame: Baseline and week 18

  2. Time with glucose values in range of 3.9 -10.0 mmol/L

    Time frame: Baseline and week 18

    Measured in percentage.

  3. Time with glucose values < 3.9 mmol/l

    Time frame: Baseline and week 18

    Measured in percentage.

  4. Time with glucose values < 3.0 mmol/l

    Time frame: Baseline and week 18

    Measured in percentage.

  5. Time with glucose values > 10.0 mmol/l

    Time frame: Baseline and week 18

    Measured in percentage.

  6. Time with glucose values > 13.9 mmol/l

    Time frame: Baseline and week 18

    Measured in percentage.

  7. Sensor glucose

    Time frame: Baseline and week 18

    Measured as mmol/l with mean values and standard deviations

  8. Glucose coefficient of variation

    Time frame: Baseline and week 18

    Measured in percentage

  9. Time with rapid glucose change (> 1,5 mmol/l/15 min)

    Time frame: Baseline and week 18

    Measured in percentage.

  10. Bodyweight

    Time frame: Baseline and week 18

    Measured in kilograms.

  11. BMI standard deviation scores

    Time frame: Baseline and week 18

    Measured in the pediatric population.

  12. Total daily insulin dose

    Time frame: Baseline and week 18

    Measured in IE and assessed by 2-week insulin pump data downloads

  13. Total daily carbohydrate intake

    Time frame: Baseline and week 18

    Measured in grams and assessed by 2-week insulin pump data downloads

  14. Hypoglycaemia awareness status

    Time frame: Baseline and week 18

    Assessed by the Gold questionaire. Possible scores between 1-7 with 7 being worst hypoglycemia awareness.

  15. Hypoglycaemia awareness status

    Time frame: Baseline and week 18

    Assessed by the Clarke questionaire. Possible scores between 0-7 with 7 being worst hypoglycemia awareness.

  16. Hypoglycaemia awareness status

    Time frame: Baseline and week 18

    Assessed by the Pedersen-Bjergaard questionaire. Possible outcomes are "Aware", "Impaired" and "Unaware".

  17. Energy expenditure

    Time frame: Baseline and week 18

    Measured in kcal and assessed with 7 days of ActiGraph data.

  18. Physical activity level

    Time frame: Baseline and week 18

    Categorized as sedentary, light and moderate-to-vigorous levels, assessed with 7 days of ActiGraph data.

  19. Number of severe hypoglycaemia events

    Time frame: Baseline and week 18

    Expressed in diffence in number of events from baseline to end. Defined as cognitive impairment requiring external assistance for recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Z Sørensen, MD

CONTACT

[email protected]

26836584 ext. +45

Natalie V Olesen, MD

CONTACT

[email protected]

31627437 ext. +45

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

Acronym: AID-BEYOND

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jun 21, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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