Diabetes Mellitus, Type 1NCT06448429
Testing an Integrated Care Model Trial
A study testing Collaborative care model (CoCM) in people with Diabetes Mellitus, Type 1, run by Emory University at 1 site in United States.
Trial summary
This study aims to test the use of an adapted collaborative care model for improving the health outcomes of adults diagnosed with type 1 diabetes (T1D). The duration of the study is 18 months with 4 study survey points. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Collaborative care model (CoCM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with T1D (based on clinical record diagnosis).
Who cannot join
- Patients who do not speak English or have reliable telephone access will be excluded. ---
- Individuals with the presence of severe psychiatric illness (PHQ-9≥20) or active suicidal ideation will also be excluded and referred to specialty care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Integration of Mental Health Care Into the Treatment of Type 1 Diabetes
This study aims to test the use of an adapted collaborative care model for improving the health outcomes of adults diagnosed with type 1 diabetes (T1D). The duration of the study is 18 months with 4 study survey points. Participants will fill out an online survey regarding their psychosocial health and chronic disease management behaviors once every six months over the 18 months, and individuals who are randomly assigned to the study intervention will also consult at least once with a behavioral health consultant during the first year (active intervention period).
Read the detailed description
Type 1 diabetes (T1D) is a lifelong condition that requires consistent monitoring and management, increasing people's risk for common mental disorders that worsen diabetes self-care. Both depression and diabetes can be managed with behavioral interventions, however, they are rarely provided alongside routine diabetes care for people with T1D. In this research study, the investigators aim to evaluate the implementation and effectiveness outcomes of a collaborative care model that uses a Behavioral Health Consultant (BHC) to support lifestyle management among adults with T1D receiving diabetes care at the Grady Diabetes Clinic.
A trained clinical research coordinator will screen interested patients seeking treatment at the Grady Diabetes Center and conduct outreach to individuals who have been identified as having T1D within the Grady Diabetes Center's patient population.
Participants in the intervention group will engage with a behavioral health consultant (BHC) not affiliated with Grady who will work with them to establish personalized health goals and identify ways to manage stress and promote healthy behaviors as means to support their mental and physical health and meet their set goals (i.e., behavioral activation). Each session will be conducted over the telephone or Zoom and last 30-60 minutes, with the number and frequency of meetings established through discussions between the patient and BHC (typically 2-3 sessions for one year). Checklist and summary case reporting templates will be used to track intervention fidelity. The BHC will also participate in ongoing Zoom calls with the multi-disciplinary T1D clinical team at the Grady Diabetes Center once a month to provide updates on patients' behavioral health plans. Transitioning patients from the active intervention will involve discussions with the care team to ensure continued patient support. In cases of active suicidal ideation, the study team will notify the patient's usual diabetes care provider and the individual will be referred to psychiatric services at Grady.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Usual care, Collaborative care model (CoCM)
- Keywords
- Behavioral Health
- 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.
Usual careOther
Also called Standard of Care (SOC)
Participants will have the usual diabetes care at the Grady Diabetes Clinic.
Collaborative care model (CoCM)Other
Also called Integrated Care Model
Collaborative care will include:
- Care with a behavioral health consultant (BHC)
- Measurement-based mental health care
- Systematic caseload reviews
- Medical management of depression
The BHC will monitor depression and anxiety severity, promote behavioral change with patients through Behavioral Activation, and support the medical management of depression through participation in caseload reviews (I.e., Mental health care plans for individual patients will be reviewed monthly by a multi-disciplinary T1D clinical team and BHC). Depression treatment initiation (if warranted) by a clinician and engagement in mental health care.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative care group | Experimental | Enrolled participants assigned to the intervention arm will be offered free consultation services with a behavioral health specialist, who is also a licensed clinical social worker.
Participants randomized into the intervention group will consult with a behavioral health consultant (BHC) one or more times over the intervention period (based on the assessment of the BHC) via phone or Zoom based on the participant's preference.
The BHC will participate in systematic caseload reviews to facilitate the medical management of depression if indicated. Receives: Other: Usual care; Other: Collaborative care model (CoCM) |
| Usual Care | Active comparator | Participants randomized to the usual care will continue their routine clinical care at the diabetes clinic at Grady. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving improvements in PHQ-9 score
The proportion of patients achieving improvements in PHQ-9 score [PHQ-9<10] or a ≥50% PHQ-9 score reduction.
Measured: Baseline, 12 months, and 18 months
Proportion of patients achieving improvement in HbA1c at end of intervention
Improvement in HbA1c will be considered as HbA1c<7 or ≥0.5% HbA1c reduction
Measured: Baseline, 12 months, and 18 months
Secondary outcomes (3)
Generalized anxiety disorder scale score
Researchers will use the Generalized anxiety disorder (GAD)-7, a 7-item scale with reporting scores from 0 to 3 on all the questions. It investigates how often the patient has been bothered by seven different symptoms of anxiety during the last two weeks with response options such as: " not at all," " several days '," more than half the days," and " nearly daily " scored as 0, 1, 2, and 3, respectively. The GAD-7 is scored by adding the scores for all 7 items, giving a total score from 0 to 21. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively. Further evaluation is recommended when the score is 10 or greater.
Measured: Baseline, 12 months, and 18 months
Systolic and diastolic blood pressure (BP) measurements
Systolic and diastolic blood pressure (SBP and DBP) will be extracted from participants' medical records.
Measured: Baseline, 12 months, and 18 months
Low-density lipoprotein (LDL) cholesterol
LDL cholesterol data will be extracted from participants' medical records.
Measured: Baseline, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start10 Jun 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 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.
- More trials run by Emory UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- MQ Mental Health Research, Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Leslie Johnson, Emory University
- Investigators
- Leslie Johnson, PhD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448429
- Sponsor's protocol ID
- STUDY00007247
- Other IDs
- 2024P008665
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers will share deidentified individual participant data that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Integration of Mental Health Care Into the Treatment of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06448429
- Acronym / sponsor ID
- STUDY00007247
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Behavioral Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- MQ Mental Health Research, Juvenile Diabetes Research Foundation
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 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.
This study aims to test the use of an adapted collaborative care model for improving the health outcomes of adults diagnosed with type 1 diabetes (T1D). The duration of the study is 18 months with 4 study survey points. Participants will fill out an online survey regarding their psychosocial health and chronic disease management behaviors once every six months over the 18 months, and individuals who are randomly assigned to the study intervention will also consult at least once with a behavioral health consultant during the first year (active intervention period).
Detailed description
Type 1 diabetes (T1D) is a lifelong condition that requires consistent monitoring and management, increasing people's risk for common mental disorders that worsen diabetes self-care. Both depression and diabetes can be managed with behavioral interventions, however, they are rarely provided alongside routine diabetes care for people with T1D. In this research study, the investigators aim to evaluate the implementation and effectiveness outcomes of a collaborative care model that uses a Behavioral Health Consultant (BHC) to support lifestyle management among adults with T1D receiving diabetes care at the Grady Diabetes Clinic.
A trained clinical research coordinator will screen interested patients seeking treatment at the Grady Diabetes Center and conduct outreach to individuals who have been identified as having T1D within the Grady Diabetes Center's patient population.
Participants in the intervention group will engage with a behavioral health consultant (BHC) not affiliated with Grady who will work with them to establish personalized health goals and identify ways to manage stress and promote healthy behaviors as means to support their mental and physical health and meet their set goals (i.e., behavioral activation). Each session will be conducted over the telephone or Zoom and last 30-60 minutes, with the number and frequency of meetings established through discussions between the patient and BHC (typically 2-3 sessions for one year). Checklist and summary case reporting templates will be used to track intervention fidelity. The BHC will also participate in ongoing Zoom calls with the multi-disciplinary T1D clinical team at the Grady Diabetes Center once a month to provide updates on patients' behavioral health plans. Transitioning patients from the active intervention will involve discussions with the care team to ensure continued patient support. In cases of active suicidal ideation, the study team will notify the patient's usual diabetes care provider and the individual will be referred to psychiatric services at Grady.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative care group | Experimental | Other: Usual care, Other: Collaborative care model (CoCM)Enrolled participants assigned to the intervention arm will be offered free consultation services with a behavioral health specialist, who is also a licensed clinical social worker. Participants randomized into the intervention group will consult with a behavioral health consultant (BHC) one or more times over the intervention period (based on the assessment of the BHC) via phone or Zoom based on the participant's preference. The BHC will participate in systematic caseload reviews to facilitate the medical management of depression if indicated. |
| Usual Care | Active comparator | Other: Usual careParticipants randomized to the usual care will continue their routine clinical care at the diabetes clinic at Grady. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (≥18 years) with T1D (based on clinical record diagnosis).
Key exclusion criteria (2 listed)
- Patients who do not speak English or have reliable telephone access will be excluded. ---
- Individuals with the presence of severe psychiatric illness (PHQ-9≥20) or active suicidal ideation will also be excluded and referred to specialty care.
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 |
|---|---|---|
| Usual careAlso: Standard of Care (SOC)Participants will have the usual diabetes care at the Grady Diabetes Clinic. | Other | Collaborative care group, Usual Care |
| Collaborative care model (CoCM)Also: Integrated Care ModelCollaborative care will include: * Care with a behavioral health consultant (BHC) * Measurement-based mental health care * Systematic caseload reviews * Medical management of depression The BHC will monitor depression and anxiety severity, promote behavioral change with patients through Behavioral Activation, and support the medical management of depression through participation in caseload reviews (I.e., Mental health care plans for individual patients will be reviewed monthly by a multi-disciplinary T1D clinical team and BHC). Depression treatment initiation (if warranted) by a clinician and engagement in mental health care. | Other | Collaborative care group |
Primary outcome
Proportion of patients achieving improvements in PHQ-9 score
Time frame: Baseline, 12 months, and 18 months
The proportion of patients achieving improvements in PHQ-9 score [PHQ-9<10] or a ≥50% PHQ-9 score reduction.
Proportion of patients achieving improvement in HbA1c at end of intervention
Time frame: Baseline, 12 months, and 18 months
Improvement in HbA1c will be considered as HbA1c<7 or ≥0.5% HbA1c reduction
3 secondary outcomes
Generalized anxiety disorder scale score
Time frame: Baseline, 12 months, and 18 months
Systolic and diastolic blood pressure (BP) measurements
Time frame: Baseline, 12 months, and 18 months
Low-density lipoprotein (LDL) cholesterol
Time frame: Baseline, 12 months, and 18 months
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 11 Sep 2026.
- Individual participant dataSharing planned: Yes. Researchers will share deidentified individual participant data that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).
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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.
Leslie Johnson, PhD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care model (CoCM) in people with Diabetes Mellitus, Type 1, run by Emory University 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. 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?
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?
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?
Proportion of patients achieving improvements in PHQ-9 score (time frame: Baseline, 12 months, and 18 months). The study lists 2 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 11 Sep 2026.