Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorSteno Diabetes Center Copenhagen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Automated insuling delivery system

    Device

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

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Adults with type 1 diabetes (intervention)Experimental treatment 1 intervention
Group B: Adults with type 1 diabetes (control)No intervention 0 interventions
Group C: Children with type 1 diabetes (intervention)Experimental treatment 1 intervention
Group D: Children with type 1 diabetes (control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and week 18

Secondary outcomes

1

Total sleep duration

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

Time frame
Baseline and week 18
2

Time in sleep stages

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

Time frame
Baseline and week 18
3

Time in sleep stages

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

Time frame
Baseline and week 18
4

Sleep latency

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

Time frame
Baseline and week 18

Other outcomes

1

HbA1c

Time frame
Baseline and week 18
2

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

Measured in percentage.

Time frame
Baseline and week 18
3

Time with glucose values < 3.9 mmol/l

Measured in percentage.

Time frame
Baseline and week 18
4

Time with glucose values < 3.0 mmol/l

Measured in percentage.

Time frame
Baseline and week 18

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Steno Diabetes Center Copenhagen

Lead sponsor

Aarhus University Hospital

Collaborator