Actively Recruiting

Phase Not Applicable
Age: 7Years +
All Genders
NCT06469593

Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

Led by Steno Diabetes Center Copenhagen · Updated on 2024-06-21

200

Participants Needed

3

Research Sites

184 weeks

Total Duration

On this page

Sponsors

S

Steno Diabetes Center Copenhagen

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

Who Can Participate

Age: 7Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with type 1 diabetes for 3 years or more
  • Using continuous glucose monitoring (CGM) or intermittently scanned CGM for at least 6 months
  • Approval from a healthcare provider to start automated insulin delivery (AID)
  • Chosen specific AID system before screening after being fully informed
  • Children aged 7 to 17 years
  • Diagnosed with type 1 diabetes for at least 6 months
  • Using CGM or intermittently scanned CGM for at least 6 months
  • Approval from a healthcare provider to start AID
  • Chosen specific AID system before screening after being fully informed
Not Eligible

You will not qualify if you...

  • Use of anti-diabetic medicines other than insulin, corticosteroids, or drugs affecting glucose metabolism during the study or within 30 days before starting
  • Prior use of commercial or open-source AID systems
  • Daily use of paracetamol (acetaminophen)
  • Breastfeeding, pregnancy, or planning pregnancy within 4 months
  • Alcohol or drug abuse
  • Severe heart disease
  • Retinopathy that prevents HbA1c below 53 mmol/mol
  • Other medical or psychological conditions making participation unsuitable
  • Lack of compliance with important study procedures as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Steno Diabetes Center Copenhagen

Herlev, Greater Copenhagen, Denmark, 2730

Actively Recruiting

2

Steno Diabetes Center Aarhus

Aarhus, Denmark, 8200

Actively Recruiting

3

Diagnostisk Center, Regionshospitalet Silkeborg

Silkeborg, Denmark, 8200

Actively Recruiting

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Research Team

M

Michael Z Sørensen, MD

CONTACT

N

Natalie V Olesen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics | DecenTrialz