AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Sponsors
Source
Steno Diabetes Center Copenhagen
Oversight Info
Has Dmc
No
Is Fda Regulated Device
No
Is Fda Regulated Drug
No
Brief 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.
Overall Status
Recruiting
Start Date
2024-06-15
Completion Date
2027-12-31
Primary Completion Date
2025-12-31
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Difference in change from baseline to study end in sleep efficiency between the two groups. |
Baseline and week 18 |
Secondary Outcome
Measure |
Time Frame |
|
Total sleep duration |
Baseline and week 18 |
|
Time in sleep stages |
Baseline and week 18 |
|
Time in sleep stages |
Baseline and week 18 |
|
Sleep latency |
Baseline and week 18 |
|
Waking after sleep onset |
Baseline and week 18 |
|
24-hour blood pressure |
Baseline and week 18 |
|
Heart rate variability |
Baseline and week 18 |
|
Heart rate variability |
Baseline and week 18 |
|
Heart rate variability |
Baseline and week 18 |
|
Heart rate variability |
Baseline and week 18 |
|
Cognitive function |
Baseline and week 18 |
|
Cognitive function |
Baseline and week 18 |
|
Cognitive function |
Baseline and week 18 |
|
Cognitive function |
Baseline and week 18 |
|
Inflammatory markers |
Baseline and week 18 |
|
Hypoglycaemia Fear Survey scores |
Baseline and week 18 |
|
Diabetes Distress Scale scores |
Baseline and week 18 |
|
Pittsburgh Sleep Quality Index scores |
Baseline and week 18 |
|
EuroQol 5-Domain scores |
Baseline and week 18 |
|
5-item World Health Organization Well-Being Index (WHO-5) scores |
Baseline and week 18 |
|
Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores |
Baseline and week 18 |
|
Sleep efficiency |
Baseline and week 18 |
|
Wake time after sleep onset |
Baseline and week 18 |
Enrollment
200
Condition
Intervention
Intervention Type
Device
Intervention Name
Description
Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS
Arm Group Label
Adults with type 1 diabetes (intervention)
Children with type 1 diabetes (intervention)
Other Name
Closed-loop insulin pumps
Eligibility
Criteria
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
Gender
All
Minimum Age
7 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Kirsten Nørgaard, MD, Prof. |
Principal Investigator |
Steno Diabetes Center Copenhagen |
|
Kurt Kristensen, MD, PhD |
Principal Investigator |
Aarhus University Hospital |
Overall Contact
Last Name
Michael Z Sørensen, MD
Phone
26836584
Phone Ext
+45
michael.zaucha.soerensen.02@regionh.dk
Location
Facility |
Status |
Contact |
|
Steno Diabetes Center Copenhagen Herlev Greater Copenhagen 2730 Denmark |
Recruiting |
Last Name: Kirsten Nørgaard |
|
Steno Diabetes Center Aarhus Aarhus 8200 Denmark |
Recruiting |
Last Name: Kurt Kristensen |
|
Diagnostisk Center, Regionshospitalet Silkeborg Silkeborg 8200 Denmark |
Recruiting |
Last Name: Klavs W Hansen |
Location Countries
Country
Denmark
Verification Date
2024-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Steno Diabetes Center Copenhagen
Investigator Full Name
Kirsten Nørgaard
Investigator Title
Professor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
4
Intervention Browse
Mesh Term
Insulin
Arm Group
Arm Group Label
Adults with type 1 diabetes (intervention)
Arm Group Type
Experimental
Arm Group Label
Adults with type 1 diabetes (control)
Arm Group Type
No Intervention
Arm Group Label
Children with type 1 diabetes (intervention)
Arm Group Type
Experimental
Description
Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years
accordingly
Arm Group Label
Children with type 1 diabetes (control)
Arm Group Type
No Intervention
Description
Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years
accordingly
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Natalie V Olesen, MD
Phone
31627437
Phone Ext
+45
nataol@rm.dk
Acronym
AID-BEYOND
Other Outcome
Measure
HbA1c
Time Frame
Baseline and week 18
Measure
Time with glucose values in range of 3.9 -10.0 mmol/L
Time Frame
Baseline and week 18
Description
Measured in percentage.
Measure
Time with glucose values < 3.9 mmol/l
Time Frame
Baseline and week 18
Description
Measured in percentage.
Measure
Time with glucose values < 3.0 mmol/l
Time Frame
Baseline and week 18
Description
Measured in percentage.
Measure
Time with glucose values > 10.0 mmol/l
Time Frame
Baseline and week 18
Description
Measured in percentage.
Measure
Time with glucose values > 13.9 mmol/l
Time Frame
Baseline and week 18
Description
Measured in percentage.
Measure
Sensor glucose
Time Frame
Baseline and week 18
Description
Measured as mmol/l with mean values and standard deviations
Measure
Glucose coefficient of variation
Time Frame
Baseline and week 18
Description
Measured in percentage
Measure
Time with rapid glucose change (> 1,5 mmol/l/15 min)
Time Frame
Baseline and week 18
Description
Measured in percentage.
Measure
Bodyweight
Time Frame
Baseline and week 18
Description
Measured in kilograms.
Measure
BMI standard deviation scores
Time Frame
Baseline and week 18
Description
Measured in the pediatric population.
Measure
Total daily insulin dose
Time Frame
Baseline and week 18
Description
Measured in IE and assessed by 2-week insulin pump data downloads
Measure
Total daily carbohydrate intake
Time Frame
Baseline and week 18
Description
Measured in grams and assessed by 2-week insulin pump data downloads
Measure
Hypoglycaemia awareness status
Time Frame
Baseline and week 18
Description
Assessed by the Gold questionaire. Possible scores between 1-7 with 7 being worst
hypoglycemia awareness.
Measure
Hypoglycaemia awareness status
Time Frame
Baseline and week 18
Description
Assessed by the Clarke questionaire. Possible scores between 0-7 with 7 being worst
hypoglycemia awareness.
Measure
Hypoglycaemia awareness status
Time Frame
Baseline and week 18
Description
Assessed by the Pedersen-Bjergaard questionaire. Possible outcomes are "Aware",
"Impaired" and "Unaware".
Measure
Energy expenditure
Time Frame
Baseline and week 18
Description
Measured in kcal and assessed with 7 days of ActiGraph data.
Measure
Physical activity level
Time Frame
Baseline and week 18
Description
Categorized as sedentary, light and moderate-to-vigorous levels, assessed with 7 days of
ActiGraph data.
Measure
Number of severe hypoglycaemia events
Time Frame
Baseline and week 18
Description
Expressed in diffence in number of events from baseline to end. Defined as cognitive
impairment requiring external assistance for recovery.
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, open-label study comparing type-1 diabetes patients receiving usual
treatment, with patients transitioning to AID systems
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
June 11, 2024
Study First Submitted Qc
June 17, 2024
Study First Posted
June 21, 2024
Last Update Submitted
June 17, 2024
Last Update Submitted Qc
June 17, 2024
Last Update Posted
June 21, 2024
ClinicalTrials.gov processed this data on December 13, 2024
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.