Type1diabetesSunDIALNCT03832790
Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes
An observational study of Type1diabetes and Adolescent Behavior, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Type1diabetes, Adolescent Behavior, Sleep
- What is being tested?
- observation
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to 30 Jun 2023
- 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 14 to 19 years
- All sexes
- Child, Adult
Study population: Adolescents with type 1 diabetes
Who may be able to join
- attending high school
- diagnosis of type 1 diabetes >1 year
Who cannot join
- current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on sleep disorders screening measures
- regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids)
- HbA1c ≥11 or >14% for the previous 2+ measurements
- IQ<70 or severe mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.
- Conditions
- Type1diabetes, Adolescent Behavior, Sleep
- Being tested
- observation
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
| Study group | Role | What they receive |
|---|---|---|
| adolescents with type 1 diabetes | Adolescents ages 14-19 with type 1 diabetes Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c
Measured: at 60 days
glycemic variability
CGM glucose SD
Measured: at 2 weeks
insulin sensitivity from hyperinsulinemic euglycemic clamp
Si
Measured: at study entry (baseline)
BMI
body mass index
Measured: at study entry (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start4 Dec 2019
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Colorado Clinical & Translational Sciences Institute, Ludeman Family Center for Women's Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832790
- Sponsor's protocol ID
- 19-0186
- Acronym
- SunDIAL
- Status last verified
- Sep 2024
- First submitted
- 4 Feb 2019
- Last updated
- 1 Oct 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03832790
- Acronym / sponsor ID
- SunDIAL / 19-0186
- Conditions
- Type1diabetes, Adolescent Behavior, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Colorado Clinical & Translational Sciences Institute, Ludeman Family Center for Women's Health Research
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Feb 2019 (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.
Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescents with type 1 diabetes | – | Other: observationAdolescents ages 14-19 with type 1 diabetes |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents with type 1 diabetes
Key inclusion criteria (2 listed)
- attending high school
- diagnosis of type 1 diabetes >1 year
Key exclusion criteria (4 listed)
- current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on sleep disorders screening measures
- regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids)
- HbA1c ≥11 or >14% for the previous 2+ measurements
- IQ<70 or severe mental illness
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 |
|---|---|---|
| observationobservation | Other | adolescents with type 1 diabetes |
Primary outcome
HbA1c
Time frame: at 60 days
HbA1c
glycemic variability
Time frame: at 2 weeks
CGM glucose SD
insulin sensitivity from hyperinsulinemic euglycemic clamp
Time frame: at study entry (baseline)
Si
BMI
Time frame: at study entry (baseline)
body mass index
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 1 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Type1diabetes and Adolescent Behavior, 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 2 inclusion and 4 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 1 Oct 2024. 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?
HbA1c (time frame: at 60 days). The study lists 4 primary outcomes in all. 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 1 Oct 2024.