DiabetesGUIDENCT07689877
Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study
A study testing Integrated Digital Health (IDH) platform and Provider engagement in people with Diabetes and Diabetes Type 2, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Type 2
- What is being tested?
- Integrated Digital Health (IDH) platform and Provider engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Mar 2031
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of T2D for at least one year
- recent 3 month-HbA1c, 8-11%
- ownership of a smartphone
- English or Spanish speaking.
Who cannot join
- pregnant
- not available or willing to use CGM or study device/platform
- serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia)
- In addition to the self-report of the HbA1c within the past 3 months, potential participants will be screened with a point-of-care (POC) HbA1c (A1CNow®+).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale School of Nursing
New Haven, Connecticut, 06477
About this study
The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.
Read the detailed description
Participants will complete a total of three study visits: a baseline visit (which includes consent, screening, and enrollment procedures), a 16-week follow-up visit, and a 32-week follow-up visit. Each study visit is expected to last approximately 30 minutes. In addition, participants will complete study surveys throughout the study period, which are expected to require approximately 30-40 minutes per survey. Depending on study group assignment, participants may also use study devices and mobile applications to track health behaviors and/or participate in telehealth visits with a healthcare provider. The frequency and duration of these activities will vary by study group.
- Conditions
- Diabetes, Diabetes Type 2
- Being tested
- Integrated Digital Health (IDH) platform, Provider engagement
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Digital Health (IDH) platformBehavioural
CGM, wearable for physical activity and sleep, food scan/log
Provider engagementBehavioural
Weekly feedback through the IDH platform plus monthly video calls
| Study group | Role | What they receive |
|---|---|---|
| Group A: Continuous Glucose Monitoring (CGM)-only | No intervention | Continuous Glucose Monitoring (CGM)-only |
| Group B: Integrated Digital Health (IDH) platform without provider engagement | Experimental | IDH without provider engagement Receives: Behavioral: Integrated Digital Health (IDH) platform |
| Group C: Integrated Digital Health (IDH) platform with provider engagement | Experimental | IDH with provider engagement Receives: Behavioral: Integrated Digital Health (IDH) platform; Behavioral: Provider engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hemoglobin A1c (HbA1c)
HbA1c in milligrams per deciliter (mg/dL) will be measured using blood testing conducted according to the standardized procedures of the National Glycohemoglobin Standardization Program (NGSP).
Measured: Baseline, 16 weeks and 32 weeks
Mean Glucose Variability (Coefficient of Variation [%CV])
Glucose variability will be derived from continuous glucose monitoring (CGM) data and calculated as the coefficient of variation (CV = standard deviation/mean glucose × 100). This measure reflects intra- and inter-day fluctuations in glucose levels. Consistent with consensus recommendations, a CV ≤36% is considered stable glucose variability.
Measured: Baseline, 16 weeks and 32 weeks
Percentage of glucose readings with Time in Range (TIR)
TIR will be derived from CGM data and calculated as the percentage of glucose readings and time per day within the target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L). Consistent with consensus recommendations, a TIR ≥70% is considered an indicator of optimal glycemic management.
Measured: Baseline, 16 weeks and 32 weeks
Secondary outcomes (4)
Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA)
12-item validated measure evaluating adherence to diabetes self-care behaviors, including diet, physical activity, blood glucose monitoring, and medication adherence. Total score range 0-7 with higher scores indicating more adherence.
Measured: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Management Self-Efficacy Scale
20-item validated instrument measuring participants' confidence in their ability to manage diabetes-related tasks and challenges. Total score range 1-5 with higher scores indicating a greater level of self-efficacy.
Measured: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Distress Scale
17-item scale which assesses distress associated with diabetes management, healthcare providers, emotional burden, and interpersonal concerns. Total score range 1-6 with higher scores indicating more distress.
Measured: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Quality of Life Brief Clinical Inventory
15-item validated instrument evaluating the impact of diabetes on physical, emotional, and social well-being. Total score range 1-5 with higher scores indicating a more negative perspective of the condition.
Measured: Baseline, 16 weeks and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Yale 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689877
- Sponsor's protocol ID
- 2000043169
- Other IDs
- 1R01DK149276-01
- Acronym
- GUIDE
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be shared per NIH data sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study
- ClinicalTrials.gov ID
- NCT07689877
- Acronym / sponsor ID
- GUIDE / 2000043169
- Conditions
- Diabetes, Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 8 Jul 2026 (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 evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.
Detailed description
Participants will complete a total of three study visits: a baseline visit (which includes consent, screening, and enrollment procedures), a 16-week follow-up visit, and a 32-week follow-up visit. Each study visit is expected to last approximately 30 minutes. In addition, participants will complete study surveys throughout the study period, which are expected to require approximately 30-40 minutes per survey. Depending on study group assignment, participants may also use study devices and mobile applications to track health behaviors and/or participate in telehealth visits with a healthcare provider. The frequency and duration of these activities will vary by study group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Continuous Glucose Monitoring (CGM)-only | No intervention | –Continuous Glucose Monitoring (CGM)-only |
| Group B: Integrated Digital Health (IDH) platform without provider engagement | Experimental | Behavioral: Integrated Digital Health (IDH) platformIDH without provider engagement |
| Group C: Integrated Digital Health (IDH) platform with provider engagement | Experimental | Behavioral: Integrated Digital Health (IDH) platform, Behavioral: Provider engagementIDH with provider engagement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of T2D for at least one year
- recent 3 month-HbA1c, 8-11%
- ownership of a smartphone
- English or Spanish speaking.
Key exclusion criteria (4 listed)
- pregnant
- not available or willing to use CGM or study device/platform
- serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia)
- In addition to the self-report of the HbA1c within the past 3 months, potential participants will be screened with a point-of-care (POC) HbA1c (A1CNow®+).
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 |
|---|---|---|
| Integrated Digital Health (IDH) platformCGM, wearable for physical activity and sleep, food scan/log | Behavioural | Group B: Integrated Digital Health (IDH) platform without provider engagement, Group C: Integrated Digital Health (IDH) platform with provider engagement |
| Provider engagementWeekly feedback through the IDH platform plus monthly video calls | Behavioural | Group C: Integrated Digital Health (IDH) platform with provider engagement |
Primary outcome
Mean Hemoglobin A1c (HbA1c)
Time frame: Baseline, 16 weeks and 32 weeks
HbA1c in milligrams per deciliter (mg/dL) will be measured using blood testing conducted according to the standardized procedures of the National Glycohemoglobin Standardization Program (NGSP).
Mean Glucose Variability (Coefficient of Variation [%CV])
Time frame: Baseline, 16 weeks and 32 weeks
Glucose variability will be derived from continuous glucose monitoring (CGM) data and calculated as the coefficient of variation (CV = standard deviation/mean glucose × 100). This measure reflects intra- and inter-day fluctuations in glucose levels. Consistent with consensus recommendations, a CV ≤36% is considered stable glucose variability.
Percentage of glucose readings with Time in Range (TIR)
Time frame: Baseline, 16 weeks and 32 weeks
TIR will be derived from CGM data and calculated as the percentage of glucose readings and time per day within the target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L). Consistent with consensus recommendations, a TIR ≥70% is considered an indicator of optimal glycemic management.
4 secondary outcomes
Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA)
Time frame: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Management Self-Efficacy Scale
Time frame: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Distress Scale
Time frame: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Quality of Life Brief Clinical Inventory
Time frame: Baseline, 16 weeks and 32 weeks
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 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified study data will be shared per NIH data sharing policy.
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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.
Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN principal investigator
Yale University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Digital Health (IDH) platform and Provider engagement in people with Diabetes and Diabetes Type 2, run by Yale 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 4 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: opening soon, as of the sponsor's last update on 29 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?
Contact Soohyun Nam, PhD (203-737-2822, soohyun.nam@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Hemoglobin A1c (HbA1c) (time frame: Baseline, 16 weeks and 32 weeks). The study lists 3 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 29 Sep 2026.