Diabetes Type 2NCT06296550
Enhancing Digitally Delivered Diabetes Education With Real-Time CGM
A study testing Dulce Digital Text Messaging Intervention and CGM Device in people with Diabetes Type 2, run by Scripps Whittier Diabetes Institute at 1 site in United States.
Trial summary
The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Dulce Digital Text Messaging Intervention and CGM Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 30 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes
- Are not currently using a CGM
- Are not using insulin therapies
- Speak English, Spanish or Arabic
- Have A1c between 7.5% and 12.0% in last 90 days
- Have a cellphone that can receive/send text messages and counts steps
Who cannot join
- Are using insulin therapies
- Are pregnant
- Are currently using a CGM
- Are currently participating in another diabetes-related study
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, 1 recruiting
- Recruiting
Scripps Whittier Diabetes Institute
San Diego, California, 92037
Athena Philis-Tsimikas, MD, 877-944-8843, tsimikas.athena@scrippshealth.org
Kallie Brown, PhD, 858-258-3555, brown.kallie@scrippshealth.org
About this study
Official title: Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes
The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.
Read the detailed description
The current research study seeks to investigate the impact of incorporating Continuous Glucose Monitoring (CGM) into the evidence-based text messaging diabetes education program, Dulce Digital, focusing on individuals with Type 2 Diabetes (T2D) who are not on insulin therapy. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In standard care, individuals with T2D, particularly those not on insulin, may not routinely have access to CGM devices. The CGM device, an integral part of recommended diabetes therapy, is FDA approved for use in all people with diabetes. However, reimbursement for CGM devices varies by health plans, and currently, Centers for Medicare \& Medicaid Services (CMS) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. Despite this, the investigators hypothesize that there are both clinical and financial benefits to providing a CGM device during diabetes self-management education for individuals with non-insulin-using T2D. This study aims to determine if adding a CGM device for this patient category yields significant benefits, contributing to the understanding of the potential advantages and informing future diabetes care practices.
- Conditions
- Diabetes Type 2
- Being tested
- Dulce Digital Text Messaging Intervention, CGM Device
- Keywords
- Diabetes, CGM, Diabetes Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulce Digital Text Messaging InterventionOther
Text-based education support program:
- Participants will receive text messages about diabetes and how to take care of diabetes and health. Participants will receive 2-3 messages every day for first 3 months, and then will slowly decrease over the last 3-months.
- Participants will also receive text messages that will ask them to test their blood sugar and text back blood sugar reading.
CGM DeviceOther
Participants will be provided continuous glucose monitors (Dexcom G7) to actively monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). In addition, participants will attend an information session (group or individual; in-person or virtual) that will provide instructions on using continuous glucose monitors.
| Study group | Role | What they receive |
|---|---|---|
| CGM Group | Experimental | Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). Receives: Other: Dulce Digital Text Messaging Intervention; Other: CGM Device |
| Usual Care Blood Glucose Monitoring Group | Other | Participants will use standard blood glucose monitoring devices that are covered by health insurance. Receives: Other: Dulce Digital Text Messaging Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measures participants A1c using lab results provided from healthcare provider.
Measured: 6 months
Secondary outcomes (5)
CGM Metric Time in Range
Measures the percentage of time a participant's blood glucose levels stay within the target range using CGM device.
Measured: 6 months
CGM Metric Time above Range
Measures the percentage of time a participant's blood glucose levels exceed the target range using CGM device.
Measured: 6 months
CGM Metric Time Below Range
Measures the percentage of time a participant's blood glucose levels fall below the target range using CGM device.
Measured: 6 months
Summary of Diabetes Self Care Activities (SDSCA) Survey
Summary of Diabetes Self Care Activities Survey measures frequency and consistency of diabetes self-care activities during the past 7 days. Possible scores range from 0 (0 Days to 7 (7 Days). Higher scores indicate better compliance with diabetes self-care.
Measured: 6 months
Diabetes Distress Scale
The Diabetes Distress Scale measures four critical dimensions of diabetes distress for participants: emotional, burden, regimen distress, interpersonal distress and physical distress. Possible scores range from 1 (Not a Problem) to 6 (A Very Serious Problem) with higher scores indicating higher levels of diabetes-related distress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start3 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296550
- Sponsor's protocol ID
- Dulce Digital CGM
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2024
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06296550
- Acronym / sponsor ID
- Dulce Digital CGM
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes, CGM, Diabetes Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Mar 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.
The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.
Detailed description
The current research study seeks to investigate the impact of incorporating Continuous Glucose Monitoring (CGM) into the evidence-based text messaging diabetes education program, Dulce Digital, focusing on individuals with Type 2 Diabetes (T2D) who are not on insulin therapy. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In standard care, individuals with T2D, particularly those not on insulin, may not routinely have access to CGM devices. The CGM device, an integral part of recommended diabetes therapy, is FDA approved for use in all people with diabetes. However, reimbursement for CGM devices varies by health plans, and currently, Centers for Medicare \& Medicaid Services (CMS) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. Despite this, the investigators hypothesize that there are both clinical and financial benefits to providing a CGM device during diabetes self-management education for individuals with non-insulin-using T2D. This study aims to determine if adding a CGM device for this patient category yields significant benefits, contributing to the understanding of the potential advantages and informing future diabetes care practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM Group | Experimental | Other: Dulce Digital Text Messaging Intervention, Other: CGM DeviceParticipants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). |
| Usual Care Blood Glucose Monitoring Group | Other | Other: Dulce Digital Text Messaging InterventionParticipants will use standard blood glucose monitoring devices that are covered by health insurance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 diabetes
- Are not currently using a CGM
- Are not using insulin therapies
- Speak English, Spanish or Arabic
- Have A1c between 7.5% and 12.0% in last 90 days
Key exclusion criteria (4 listed)
- Are using insulin therapies
- Are pregnant
- Are currently using a CGM
- Are currently participating in another diabetes-related study
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 |
|---|---|---|
| Dulce Digital Text Messaging InterventionText-based education support program: * Participants will receive text messages about diabetes and how to take care of diabetes and health. Participants will receive 2-3 messages every day for first 3 months, and then will slowly decrease over the last 3-months. * Participants will also receive text messages that will ask them to test their blood sugar and text back blood sugar reading. | Other | CGM Group, Usual Care Blood Glucose Monitoring Group |
| CGM DeviceParticipants will be provided continuous glucose monitors (Dexcom G7) to actively monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). In addition, participants will attend an information session (group or individual; in-person or virtual) that will provide instructions on using continuous glucose monitors. | Other | CGM Group |
Primary outcome
HbA1c
Time frame: 6 months
Measures participants A1c using lab results provided from healthcare provider.
5 secondary outcomes
CGM Metric Time in Range
Time frame: 6 months
CGM Metric Time above Range
Time frame: 6 months
CGM Metric Time Below Range
Time frame: 6 months
Summary of Diabetes Self Care Activities (SDSCA) Survey
Time frame: 6 months
Diabetes Distress Scale
Time frame: 6 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 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Athena Philis-Tsimikas, MD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dulce Digital Text Messaging Intervention and CGM Device in people with Diabetes Type 2, run by Scripps Whittier Diabetes Institute 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 6 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: looking for participants now, as of the sponsor's last update on 6 Mar 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 Kallie Brown, PhD (858-258-3555, brown.kallie@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 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 6 Mar 2026.