Diabetes Mellitus, Type 1NCT05915975
Integrated Behavioral Healthcare for Youth With Type 1 Diabetes
A study testing Behavioral Care Coordinated with Medical Care Intervention and Behavioral Care Not Coordinated with Medical Care Intervention in people with Diabetes Mellitus, Type 1, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Behavioral Care Coordinated with Medical Care Intervention and Behavioral Care Not Coordinated with Medical Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 Diabetes diagnosed for one year or more
- Latino or Black ethnicity/race
- Speak and read English or Spanish
- Eligibility for Medicaid
Who cannot join
- Significant developmental disability
- Serious psychiatric disorder
- Another serious chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Behavioral Healthcare for Low-Income Ethnic Minority Youth With Type 1 Diabetes
The purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Behavioral Care Coordinated with Medical Care Intervention, Behavioral Care Not Coordinated with Medical Care Intervention
- 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.
Behavioral Care Coordinated with Medical Care InterventionBehavioural
Participants will be meeting with a behavioral health provider during their clinic visit. Subsequent visits can be held either via telehealth or in-person. Participants should expect weekly visits during the first two months and less frequent visits (biweekly or monthly) for the last two months. Some sessions that are provided via telehealth might be video recorded and later reviewed to ensure that the program is being delivered as intended.
Behavioral Care Not Coordinated with Medical Care InterventionBehavioural
Participants will meet with a study team member during their in-person visit and will receive a list of clinics that are panelled with their insurance. The participants will be responsible for calling the clinics to set up their appointments. Services might be provided in person or via telehealth based on the participant's preference and the clinics' availability.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Care Coordinated with Medical Care | Experimental | Participants in this group will work with a study team member for four months to improve your skills to manage diabetes, to strengthen the child-caregiver relationship, and/or to address emotional challenges that your child might be experiencing. Receives: Behavioral: Behavioral Care Coordinated with Medical Care Intervention |
| Behavioral Care Not Coordinated with Medical Care | Active comparator | Participants will receive the standard of care treatment for four months plus a list of clinics that accept their insurance. Receives: Behavioral: Behavioral Care Not Coordinated with Medical Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic Control
Will be measured by glycosylated hemoglobin A1c
Measured: Baseline and 4 months
Secondary outcomes (1)
Change in Diabetes Self-Management
We will measure Type 1 Diabetes Self-management using the Diabetes Management Questionnaire (DMQ; Score Range: 0-100, higher scores indicate greater adherence to diabetes management).
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start7 Nov 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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.
- More trials run by University of MiamiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiza Vianna Mali, University of Miami
- Investigators
- Luiza V Mali, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915975
- Sponsor's protocol ID
- 20230308
- Status last verified
- Oct 2024
- First submitted
- 14 Jun 2023
- Last updated
- 9 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Behavioral Healthcare for Low-Income Ethnic Minority Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05915975
- Acronym / sponsor ID
- 20230308
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Jun 2023 (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 purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Care Coordinated with Medical Care | Experimental | Behavioral: Behavioral Care Coordinated with Medical Care InterventionParticipants in this group will work with a study team member for four months to improve your skills to manage diabetes, to strengthen the child-caregiver relationship, and/or to address emotional challenges that your child might be experiencing. |
| Behavioral Care Not Coordinated with Medical Care | Active comparator | Behavioral: Behavioral Care Not Coordinated with Medical Care InterventionParticipants will receive the standard of care treatment for four months plus a list of clinics that accept their insurance. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Type 1 Diabetes diagnosed for one year or more
- Latino or Black ethnicity/race
- Speak and read English or Spanish
- Eligibility for Medicaid
Key exclusion criteria (3 listed)
- Significant developmental disability
- Serious psychiatric disorder
- Another serious chronic 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 |
|---|---|---|
| Behavioral Care Coordinated with Medical Care InterventionParticipants will be meeting with a behavioral health provider during their clinic visit. Subsequent visits can be held either via telehealth or in-person. Participants should expect weekly visits during the first two months and less frequent visits (biweekly or monthly) for the last two months. Some sessions that are provided via telehealth might be video recorded and later reviewed to ensure that the program is being delivered as intended. | Behavioural | Behavioral Care Coordinated with Medical Care |
| Behavioral Care Not Coordinated with Medical Care InterventionParticipants will meet with a study team member during their in-person visit and will receive a list of clinics that are panelled with their insurance. The participants will be responsible for calling the clinics to set up their appointments. Services might be provided in person or via telehealth based on the participant's preference and the clinics' availability. | Behavioural | Behavioral Care Not Coordinated with Medical Care |
Primary outcome
Change in Glycemic Control
Time frame: Baseline and 4 months
Will be measured by glycosylated hemoglobin A1c
1 secondary outcome
Change in Diabetes Self-Management
Time frame: Baseline and 4 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 9 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.
Luiza V Mali, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Care Coordinated with Medical Care Intervention and Behavioral Care Not Coordinated with Medical Care Intervention in people with Diabetes Mellitus, Type 1, run by University of Miami 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 4 inclusion and 3 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 9 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?
Change in Glycemic Control (time frame: Baseline and 4 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 9 Oct 2024.