NCT06296550

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 3, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

February 28, 2024

Last Update Submit

March 4, 2026

Conditions

Diabetes Type 2

Keywords

DiabetesCGMDiabetes Education

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Measures participants A1c using lab results provided from healthcare provider.

    6 months

Secondary Outcomes (5)

  • CGM Metric Time in Range

    6 months

  • CGM Metric Time above Range

    6 months

  • CGM Metric Time Below Range

    6 months

  • Summary of Diabetes Self Care Activities (SDSCA) Survey

    6 months

  • Diabetes Distress Scale

    6 months

Study Arms (2)

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).

Other: Dulce Digital Text Messaging InterventionOther: CGM Device

Usual Care Blood Glucose Monitoring Group

OTHER

Participants will use standard blood glucose monitoring devices that are covered by health insurance.

Other: Dulce Digital Text Messaging Intervention

Interventions

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 GroupUsual Care Blood Glucose Monitoring Group
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.

CGM Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Are using insulin therapies
  • Are pregnant
  • Are currently using a CGM
  • Are currently participating in another diabetes-related study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Whittier Diabetes Institute

San Diego, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Athena Philis-Tsimikas, MD

    Scripps Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kallie Brown, PhD

CONTACT

858-258-3555brown.kallie@scrippshealth.org

Athena Philis-Tsimikas, MD

CONTACT

877-944-8843philis-Tsimikas.athena@scrippshealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

April 3, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)