Type 1 DiabetesNCT04431947
Impact of Hybrid Closed-Loop Systems on Sleep and Psychosocial Outcomes in Youth With T1D and Their Parents
An observational study of Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep in youth with type 1 diabetes and their parents. Activity watches, surveys and device downloads are used to evaluate sleep in these participants. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2020to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- Child
Study population: Youth with type 1 diabetes and a parent who resides with the youth.
Who may be able to join
- Child diagnosed with type 1 diabetes for at least 3 months
- Child receives clinical care at the Barbara Davis Center for Diabetes
- Child starting an advanced HCL system as part of routine diabetes care
- Child currently living with a parent who is willing to complete surveys for this study
- Family able to read and speak English
- Parent lives at home with the child with type 1 diabetes
- Parent able to read and speak English
Who cannot join
- Child has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
- Child participating in an interventional research protocol
- Child unable to complete study procedures
- Parent has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
- Parent unable to complete study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Barbara Davis Center
Aurora, Colorado, 80045
About this study
Official title: Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents
This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep in youth with type 1 diabetes and their parents. Activity watches, surveys and device downloads are used to evaluate sleep in these participants.
Read the detailed description
Sleep is important for everyone, including youth with type 1 diabetes. New technology has shown improvements in glycemic variability, especially overnight. This study evaluates the impact of advanced hybrid closed-loop insulin delivery systems on sleep for both youth with type 1 diabetes and their parents. Study measures include wearing an actigraphy watch and completing a sleep diary for 7 days and taking surveys on sleep and psychosocial measures. Study measures occur prior to starting the hybrid closed-loop system, immediately after starting the system and at 3 and 6 months after starting the system.
- Conditions
- Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Youth | Youth, between the ages of 2 and 17, with type 1 diabetes | |
| Parent | Parents of youth with type 1 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Sleep
Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches
Measured: End of study (6 months)
Secondary outcomes (6)
Impact on Diabetes Distress
Change in diabetes-related distress using the validated Problem Areas in Diabetes survey
Measured: End of study (6 months)
Impact on Quality of Life
Change in quality of life using the validated survey Pediatric Quality of Life Inventory Diabetes Module (PedsQL)
Measured: End of study (6 months)
Impact on Fear of Hypoglycemia
Change in fear of hypoglycemia using the validated hypoglycemia fear survey
Measured: End of study (6 months)
Impact on Perceptions of Diabetes Technology
Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire
Measured: End of study (6 months)
Impact on Hybrid Closed-Loop System Use Perceptions
Change in perceptions of hybrid-closed loop systems using the validated INSPIRE survey
Measured: End of study (6 months)
Impact of Sleep on Glycemic Variability
Correlation of sleep duration and glycemic variability using hybrid closed loop device download to analyze time in range, time with low glucose and time with high glucose
Measured: End of study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start13 Mar 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Cobry, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431947
- Sponsor's protocol ID
- 20-0375
- Other IDs
- K12DK094712
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2020
- Last updated
- 25 Apr 2022
- 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents
- ClinicalTrials.gov ID
- NCT04431947
- Acronym / sponsor ID
- 20-0375
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 16 Jun 2020 (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.
This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep in youth with type 1 diabetes and their parents. Activity watches, surveys and device downloads are used to evaluate sleep in these participants.
Detailed description
Sleep is important for everyone, including youth with type 1 diabetes. New technology has shown improvements in glycemic variability, especially overnight. This study evaluates the impact of advanced hybrid closed-loop insulin delivery systems on sleep for both youth with type 1 diabetes and their parents. Study measures include wearing an actigraphy watch and completing a sleep diary for 7 days and taking surveys on sleep and psychosocial measures. Study measures occur prior to starting the hybrid closed-loop system, immediately after starting the system and at 3 and 6 months after starting the system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youth | – | –Youth, between the ages of 2 and 17, with type 1 diabetes |
| Parent | – | –Parents of youth with type 1 diabetes |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Youth with type 1 diabetes and a parent who resides with the youth.
Key inclusion criteria (7 listed)
- Child diagnosed with type 1 diabetes for at least 3 months
- Child receives clinical care at the Barbara Davis Center for Diabetes
- Child starting an advanced HCL system as part of routine diabetes care
- Child currently living with a parent who is willing to complete surveys for this study
- Family able to read and speak English
Key exclusion criteria (5 listed)
- Child has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
- Child participating in an interventional research protocol
- Child unable to complete study procedures
- Parent has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
- Parent unable to complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of Sleep
Time frame: End of study (6 months)
Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches
6 secondary outcomes
Impact on Diabetes Distress
Time frame: End of study (6 months)
Impact on Quality of Life
Time frame: End of study (6 months)
Impact on Fear of Hypoglycemia
Time frame: End of study (6 months)
Impact on Perceptions of Diabetes Technology
Time frame: End of study (6 months)
Impact on Hybrid Closed-Loop System Use Perceptions
Time frame: End of study (6 months)
Impact of Sleep on Glycemic Variability
Time frame: End of study (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- 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. This study is not recruiting at the moment.
Erin Cobry, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Sleep (time frame: End of study (6 months)). 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 25 Apr 2022.