Diabetes Mellitus, Type 1EquiT1DNCT06899984
Using Technology to Address Disparities and Promote Healthcare Equity in Type 1 Diabetes Registry
A study testing Patient Navigator in people with Diabetes Mellitus, Type 1, run by University of Chicago at 1 site in United States.
Trial summary
This study is being done to see if using technology, with the help of a Patient Navigator, can help address disparities, improve outcomes, and promote healthcare equity in type 1 diabetes. Read more about this study
- Who is it for?
- Ages 14 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Patient Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to Mar 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 14 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females age 14 to 64 years
- Clinical diagnosis of type 1 diabetes (T1D)
- Two or more hospitalizations with diabetic ketoacidosis (DKA) within the past 5 years or hemoglobin A1c greater than 10% on two or more laboratory samples in the last 2 years.
- Informed Consent
- Has a CGMS or a prescription for a CGMS as part of their clinical care as part of their clinical care
Who cannot join
- Inability or unwillingness to share CGMS data with the study team
Trial locations and contacts
1 site in 1 country.
About this study
This study is being done to see if using technology, with the help of a Patient Navigator, can help address disparities, improve outcomes, and promote healthcare equity in type 1 diabetes.
Read the detailed description
Patients with T1D require an individualized care plan with ongoing education and support. A recent qualitative study of young adults with T1D and end-stage renal disease revealed that childhood environment, education, socio-economic status, and other determinants contributed to disengagement from treatment regimens and the development of microvascular complications early in life1. Providing participants with real-time CGMS will inform daily decision making.
This is an interventional study using prescribed real-time CGMS together with feedback and support from a Patient Navigator in patients with T1D. The aims of this study include the following.
Aim 1: To incorporate real-time CGMS and patient navigation support into the care of adolescent and adult patients with T1D and one of the following: 1.) two or more hospitalizations for DKA in the last five years or 2.) two or more hemoglobin A1c values over 10% in the last two years.
Aim 2: To collect information from participants regarding health outcomes, experiences with health care, and changes, if any, in diabetes self-management practices, diabetes distress, and diabetes health-related quality of life.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Patient Navigator
- 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.
Patient NavigatorBehavioural
Patient Navigator will provide additional support to participants using their standard of care CGM device.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigator | Experimental | Patient Navigator will provide additional support to participants using their standard of care CGM device. Receives: Behavioral: Patient Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CGM Utilization
Use of CGMS (Continuous Glucose Monitor) device measured by the percentage of time during a month that a participant is using their CGM.
Measured: Baseline to Month 48
Secondary outcomes (4)
Change in diabetes health-related quality of life
Diabetes Quality of Life Brief Clinical Inventory (Possible range of scores is 15 to 75, with higher scores indicating a negative perspective of the problem's frequency and level of dissatisfaction) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine diabetes health-related quality of life changes over time.
Measured: Baseline to Month 48
Diabetes distress changes measured by PAID
PAID (scale; 0-4) (Possible range of scores is 0 to 100, with higher scores reflecting greater emotional distress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in diabetes distress in adults over time.
Measured: Baseline to Month 48
Diabetes distress changes measured by PAID-T
PAID-T(scale; 1-6) (Possible range of scores is 26-156, with higher scores indicating greater emotional distress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in diabetes distress in teens over time.
Measured: Baseline to Month 48
Change in diabetes self-management practices
SCI-R (scale; never to always) (For scoring, items are averaged and converted to a 0 to 100 point scale, with higher scores indicating higher levels of self-care) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in diabetes self-management practices over time.
Measured: Baseline to Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start20 Nov 2020
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celeste Thomas, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899984
- Sponsor's protocol ID
- IRB20-1296
- Acronym
- EquiT1D
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy EA, Wan W, Laiteerapong N, Peek ME, Huang ES, Ali RS, Schreckenberger ZJ, Nalam H, Thomas CC. Using technology to address disparities and promote healthcare equity in Type 1 Diabetes (EquiT1D) A nonrandomized clinical trial investigating solutions to low technology use. J Clin Transl Endocrinol. 2026 Aug 11;46:100453. doi: 10.1016/j.jcte.2026.100453. eCollection 2026 Nov.
PubMed 42633177
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Address Disparities and Promote Healthcare Equity in Type 1 Diabetes Registry
- ClinicalTrials.gov ID
- NCT06899984
- Acronym / sponsor ID
- EquiT1D / IRB20-1296
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Mar 2025 (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 is being done to see if using technology, with the help of a Patient Navigator, can help address disparities, improve outcomes, and promote healthcare equity in type 1 diabetes.
Detailed description
Patients with T1D require an individualized care plan with ongoing education and support. A recent qualitative study of young adults with T1D and end-stage renal disease revealed that childhood environment, education, socio-economic status, and other determinants contributed to disengagement from treatment regimens and the development of microvascular complications early in life1. Providing participants with real-time CGMS will inform daily decision making.
This is an interventional study using prescribed real-time CGMS together with feedback and support from a Patient Navigator in patients with T1D. The aims of this study include the following.
Aim 1: To incorporate real-time CGMS and patient navigation support into the care of adolescent and adult patients with T1D and one of the following: 1.) two or more hospitalizations for DKA in the last five years or 2.) two or more hemoglobin A1c values over 10% in the last two years.
Aim 2: To collect information from participants regarding health outcomes, experiences with health care, and changes, if any, in diabetes self-management practices, diabetes distress, and diabetes health-related quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Navigator | Experimental | Behavioral: Patient NavigatorPatient Navigator will provide additional support to participants using their standard of care CGM device. |
Who may qualify
- Ages
- 14 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males or females age 14 to 64 years
- Clinical diagnosis of type 1 diabetes (T1D)
- Two or more hospitalizations with diabetic ketoacidosis (DKA) within the past 5 years or hemoglobin A1c greater than 10% on two or more laboratory samples in the last 2 years.
- Informed Consent
- Has a CGMS or a prescription for a CGMS as part of their clinical care as part of their clinical care
Key exclusion criteria (1 listed)
- Inability or unwillingness to share CGMS data with the study team
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 |
|---|---|---|
| Patient NavigatorPatient Navigator will provide additional support to participants using their standard of care CGM device. | Behavioural | Patient Navigator |
Primary outcome
Change in CGM Utilization
Time frame: Baseline to Month 48
Use of CGMS (Continuous Glucose Monitor) device measured by the percentage of time during a month that a participant is using their CGM.
4 secondary outcomes
Change in diabetes health-related quality of life
Time frame: Baseline to Month 48
Diabetes distress changes measured by PAID
Time frame: Baseline to Month 48
Diabetes distress changes measured by PAID-T
Time frame: Baseline to Month 48
Change in diabetes self-management practices
Time frame: Baseline to Month 48
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 24 Nov 2025.
- Derived from this study: PubMed 42633177Murphy EA, Wan W, Laiteerapong N, Peek ME, Huang ES, Ali RS, Schreckenberger ZJ, Nalam H, Thomas CC. Using technology to address disparities and promote healthcare equity in Type 1 Diabetes (EquiT1D) A nonrandomized clinical trial investigating solutions to low technology use. J Clin Transl Endocrinol. 2026 Aug 11;46:100453. doi: 10.1016/j.jcte.2026.100453. eCollection 2026 Nov.
- 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.
Celeste Thomas, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator in people with Diabetes Mellitus, Type 1, run by University of Chicago 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 5 inclusion and 1 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 24 Nov 2025. 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?
Change in CGM Utilization (time frame: Baseline to Month 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06899984, which also lists 1 linked publication.
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 24 Nov 2025.