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N/A N=366 Randomized Single-blind Health Services Research

Diabetes Disparities: Texting to Extend Treatment (DD-TXT)

Diabetes Mellitus, Type 2

Enrolled (actual)
366
Serious AEs
0.8%
Results posted
Jun 2026
Primary outcome: Primary: Change in HbA1c Percent Time in Control — 23.41; 21.61 percent (%) of time in control — p=.6519

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Intervention 1- DSMS+ (Behavioral); Comparison - DSMS (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Apr 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in HbA1c Percent Time in Control
23.41; 21.61 .6519
PRIMARY
Change in HbA1c
-0.36; -0.40 .7552
SECONDARY
Change in LDL
2.88; -7.68 .0351 sig
SECONDARY
Change in Systolic Blood Pressure
-2.62; -2.29 .8155
SECONDARY
Change in Diastolic Blood Pressure
-0.77; -0.65 .8648
SECONDARY
Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R)
6.57; 5.23 .3334
SECONDARY
Change in Self-reported Diabetes Self-efficacy Scale (DSES)
.03; .41 .0515
SECONDARY
Change in Self-reported Diabetes Distress Scale (DDS17)
-.13; -.32 .0857
SECONDARY
Change in Self-reported DDS17 Emotional Burden Subscale
-.14; -.45 .0326 sig
SECONDARY
Change in Self-reported DDS17 Physician-related Distress Subscale
-.13; -.20 .5892
SECONDARY
Change in Self-reported DDS17 Regimen-Related Distress Subscale
-.23; -.55 .0183 sig
SECONDARY
Change in Self-reported DDS17 Interpersonal Distress Subscale
.08; -.18 .0583
SECONDARY
Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
-1.20; -.67 .1758
SECONDARY
Change in Self-reported Physical Health Summary Score
.79; 1.09 .7527
SECONDARY
Change in Self-reported Mental Health Summary Score
-0.02; 1.02 .3626

Summary

One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. The study will seek input from diverse groups of Veterans living with diabetes to help develop a new customizable, interactive texting intervention that allows Veterans to choose what kinds of diabetes self-management support they need, and when. This diabetes support will be provided to Veterans through "Annie for Veterans", a VA texting system for self-management support. Patients will be randomized to receive a once-daily standard diabetes self-management texting intervention called DSMS based on standard diabetes self-management education content or a customizable, patient-centered diabetes self-management support intervention with additional features called DSMS Plus (DSMS+) in order to test the comparative effectiveness of these two texting interventions.

Eligibility Criteria

Inclusion Criteria

  • Veterans
  • Active VHA patients with type 2 diabetes
  • Had at least 4 VA outpatient encounters in the previous year
  • Have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in texting intervention development
  • Have HbA1c lab data (2+ values) in the 12 months prior to RCT recruitment.
  • Have inadequate glycemic control for at least 50% of the 6 months before invitation to participate

Exclusion Criteria

  • Non-Veterans
  • Not having access to their own or a cohabiting family member's cell phone or smartphone for participation
  • Not willing and able to text
  • A visual impairment that would prevent them from reading or replying to text messages
  • Cognitively incapable of consent to participate (Failure of Short Blessed Test)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04227379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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