Diabetes Mellitus, Type 1AID-BEYONDNCT06469593
Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
A study testing Automated insuling delivery system in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Automated insuling delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesDenmark
- Study dates
- 15 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Age 7-17 years
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Steno Diabetes Center Aarhus
Aarhus, 8200
Kurt Kristensen
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, Greater Copenhagen, 2730
Kirsten Nørgaard
- Recruiting
Diagnostisk Center, Regionshospitalet Silkeborg
Silkeborg, 8200
Klavs W Hansen
About this study
Official title: AID-BEYOND: 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.
Read more
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
- Diabetes Mellitus, Type 1
- Being tested
- Automated insuling delivery system
- Keywords
- Closed-loop insulin pump, Automated insulin delivery, AID systems, Artificial pancreas, Type 1 Diabetes, T1D, Sleep, Cognition, Cardiovascular risk, Inflammation
- Medical subject headings
- Diabetes Mellitus, Type 1, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated insuling delivery systemDevice
Also called Closed-loop insulin pumps
Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS
| Study group | Role | What they receive |
|---|---|---|
| Adults with type 1 diabetes (intervention) | Experimental | Not described Receives: Device: Automated insuling delivery system |
| Adults with type 1 diabetes (control) | No intervention | Not described |
| 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 Receives: Device: Automated insuling delivery system |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 18
Secondary outcomes (23)
Total sleep duration
As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.
Measured: Baseline and week 18
Time in sleep stages
As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.
Measured: Baseline and week 18
Time in sleep stages
As measured by HomeSleepTest for 3 consequtive days. Expressed in percentages.
Measured: Baseline and week 18
Sleep latency
As measured by HomeSleepTest and ActiGraph for 3 consequtive days.Expressed in minutes
Measured: Baseline and week 18
Waking after sleep onset
As measured by HomeSleepTest and Actigraph for 3 consequtive days. Expressed in minutes
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 18
Hypoglycaemia Fear Survey scores
Possible scores between 0-44, higher scores mean more fear of hypoglycemia.
Measured: Baseline and week 18
Diabetes Distress Scale scores
Possible scores between 7-42, higher scores mean more diabetes distress.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 18
Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores
Measured for children
Measured: Baseline and week 18
Sleep efficiency
Measured in percentages, assessed using 7 days of ActiGraph data, supported by daily electronic sleep diaries.
Measured: 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.
Measured: Baseline and week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start15 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label study comparing type-1 diabetes patients receiving usual treatment, with patients transitioning to AID systems
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Kirsten Nørgaard, Steno Diabetes Center Copenhagen
- Investigators
- Kirsten Nørgaard, MD, Prof., Principal investigator, Steno Diabetes Center CopenhagenKurt Kristensen, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469593
- Sponsor's protocol ID
- H-23074743
- Acronym
- AID-BEYOND
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
- ClinicalTrials.gov ID
- NCT06469593
- Acronym / sponsor ID
- AID-BEYOND / H-23074743
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Closed-loop insulin pump, Automated insulin delivery, AID systems, Artificial pancreas, Type 1 Diabetes, T1D, Sleep, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, open-label study comparing type-1 diabetes patients receiving usual treatment, with patients transitioning to AID systems
| Arm | Type | Receives |
|---|---|---|
| Adults with type 1 diabetes (intervention) | Experimental | Device: Automated insuling delivery system |
| Adults with type 1 diabetes (control) | No intervention | – |
| Children with type 1 diabetes (intervention) | Experimental | Device: Automated insuling delivery systemPediatric 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 |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated insuling delivery systemAlso: Closed-loop insulin pumpsClosed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS | Device | Adults with type 1 diabetes (intervention), Children with type 1 diabetes (intervention) |
Primary outcome
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.
23 secondary outcomes
Total sleep duration
Time frame: Baseline and week 18
Time in sleep stages
Time frame: Baseline and week 18
Time in sleep stages
Time frame: Baseline and week 18
Sleep latency
Time frame: Baseline and week 18
Waking after sleep onset
Time frame: Baseline and week 18
24-hour blood pressure
Time frame: Baseline and week 18
Heart rate variability
Time frame: Baseline and week 18
Heart rate variability
Time frame: Baseline and week 18
Heart rate variability
Time frame: Baseline and week 18
Heart rate variability
Time frame: Baseline and week 18
Cognitive function
Time frame: Baseline and week 18
Cognitive function
Time frame: Baseline and week 18
Cognitive function
Time frame: Baseline and week 18
Cognitive function
Time frame: Baseline and week 18
Inflammatory markers
Time frame: Baseline and week 18
Hypoglycaemia Fear Survey scores
Time frame: Baseline and week 18
Diabetes Distress Scale scores
Time frame: Baseline and week 18
Pittsburgh Sleep Quality Index scores
Time frame: Baseline and week 18
EuroQol 5-Domain scores
Time frame: Baseline and week 18
5-item World Health Organization Well-Being Index (WHO-5) scores
Time frame: Baseline and week 18
Sleep Screening Questionnaire Children and Adolescents (SSQ-CA) scores
Time frame: Baseline and week 18
Sleep efficiency
Time frame: Baseline and week 18
Wake time after sleep onset
Time frame: Baseline and week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsten Nørgaard, MD, Prof. principal investigator
Steno Diabetes Center Copenhagen
Kurt Kristensen, MD, PhD principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated insuling delivery system in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Z Sørensen, MD (26836584 ext. +45, michael.zaucha.soerensen.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change from baseline to study end in sleep efficiency between the two groups. (time frame: Baseline and week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.