NCT03130699

Brief Summary

This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile health) intervention that is tailored to individuals' needs and behavioral progress, in improving diabetes clinical control, adherence, and patient-provider communication in Hispanics - an at-risk, understudied population that experiences disparities in diabetes prevalence and outcomes. These striking disparities in the growing and aging US Hispanic population have taxed the US healthcare system, while significantly reducing quantity and quality of life for millions of individuals. By offering an innovative, scalable, and sustainable approach that seamlessly integrates several mHealth technologies into existing primary care team processes to improve the health of Hispanics (and eventually, other at-risk, underserved groups), DD-Me has strong potential to significantly impact public health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2021

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3.8 years

First QC Date

April 24, 2017

Results QC Date

May 12, 2025

Last Update Submit

June 18, 2025

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesmHealthMedical AssistantAutomatedAdaptive FeedbackSelf-Management SupportHispanicsHbA1cCyberinfrastructureFederally-Qualified Health CentersCost-EffectivenessT2DMPay-for-PerformanceMedication AdherenceLDL-CSystolic Blood PressureText Messaging

Outcome Measures

Primary Outcomes (6)

  • Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment

    Glycosylated Hemoglobin (HbA1c) six months after enrollment

    6 months from baseline

  • Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment

    Glycosylated Hemoglobin (HbA1c) twelve months after enrollment

    12 months from baseline

  • Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment

    Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment

    6 months from baseline

  • Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment

    Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment

    12 months from baseline

  • Systolic Blood Pressure (SBP); 6 Months From Enrollment

    Systolic blood pressure (SBP); six months from enrollment

    6 months from baseline

  • Systolic Blood Pressure (SBP); 12 Months From Enrollment

    Systolic blood pressure (SBP); twelve months from enrollment

    12 months from baseline

Secondary Outcomes (16)

  • Patient-Provider Communication; 6 Months From Enrollment

    6 months from baseline

  • Patient-Provider Communication; 12 Months From Enrollment

    12 months from baseline

  • Patient Blood Glucose Monitoring; 6 Months From Enrollment

    6 months from baseline

  • Patient Blood Glucose Monitoring; 12 Months From Enrollment

    12 months from baseline

  • Participated in Aerobic Exercise; 6 Months From Enrollment

    6 months from baseline

  • +11 more secondary outcomes

Study Arms (3)

Dulce Digital

EXPERIMENTAL

The first of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives one-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.

Behavioral: Dulce Digital

Dulce Digital-Me (Automated Delivery)

EXPERIMENTAL

The second of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.

Behavioral: Dulce Digital-Me (Automated Delivery)

Dulce Digital-Me (Medical Assistant)

EXPERIMENTAL

The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.

Behavioral: Dulce Digital-Me (Medical Assistant)

Interventions

Dulce DigitalBEHAVIORAL

One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.

Dulce Digital
Dulce Digital-Me (Automated Delivery)BEHAVIORAL

Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.

Dulce Digital-Me (Automated Delivery)
Dulce Digital-Me (Medical Assistant)BEHAVIORAL

Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.

Dulce Digital-Me (Medical Assistant)

Eligibility Criteria

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

You may qualify if:

  • Self-identified Hispanic/Latino
  • years or older
  • Registered patient of a Neighborhood Healthcare Clinic
  • Diagnosed with T2DM (Type 2 Diabetes Mellitus)
  • HbA1c ≥ 8.0% and/or SBP ≥ 160 mmHg, and/or LDL-C ≥ 100 mg/dL in the last 30 days

You may not qualify if:

  • Severe illness precluding regular clinic visits
  • Pregnant or lactating
  • Type 1 or gestational diabetes
  • Lack of minimal literacy
  • Plans to relocate
  • Severe auditory or visual problems
  • Primary language other than Spanish or English
  • Unwilling to carry a mobile phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Scripps Mercy Chula Vista

Chula Vista, California, 91910, United States

Location

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

Related Publications (2)

  • Philis-Tsimikas A, Fortmann AL, Clark T, Spierling Bagsic SR, Farcas E, Roesch SC, Schultz J, Gilmer TP, Godino JG, Savin KL, Chichmarenko M, Jones JA, Sandoval H, Gallo LC. Dulce Digital-Me: results of a randomized comparative trial of static versus adaptive digital interventions for Latine adults with diabetes. Ann Behav Med. 2025 Jan 4;59(1):kaae077. doi: 10.1093/abm/kaae077.

    PMID: 39707158DERIVED

  • Philis-Tsimikas A, Fortmann AL, Godino JG, Schultz J, Roesch SC, Gilmer TP, Farcas E, Sandoval H, Savin KL, Clark T, Chichmarenko M, Jones JA, Gallo LC. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Trials. 2022 Jan 28;23(1):80. doi: 10.1186/s13063-021-05899-x.

    PMID: 35090520DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMedication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Athena Philis-Tsimikas, MD, Co-Principal Investigator
Organization
Scripps Health
philis-tsimikas.athena@scrippshealth.org
858-678-7045

Study Officials

  • Athena Philis-Tsimikas, MD

    Scripps Whittier Diabetes Institute

    PRINCIPAL INVESTIGATOR

  • Linda Gallo, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Corporate Vice President

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 26, 2017

Study Start

October 31, 2017

Primary Completion

August 14, 2021

Study Completion

August 14, 2021

Last Updated

June 25, 2025

Results First Posted

June 25, 2025

Record last verified: 2025-06

Locations

US(2)