Recruiting

Diabetes Control

Sponsor:

George Washington University

Code:

NCT05616026

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Intervention

Attention Control

Study Details

Brief summary:

This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.

Conditions

Diabetes Mellitus

Study ID

NCT05616026

Start date

Feb 7, 2023

Status verified date

Jan, 2026

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Homeless person age ≥ 21
  • Diagnosed with type 2 DM
  • Most recent visit HbA1c ≥ 8%
  • English/Spanish speaking
  • Connected to study sites' shelter-clinics for care

Exclusion Criteria:

  • Pregnant or within 3 months postpartum
  • Has an uncontrolled severe illness
  • Has had a heart attack or stroke in the previous 6 months
  • Inability to read/respond to texts
  • Inability to provide informed consent
  • Receiving inpatient care for severe substance abuse

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

The intervention (INT) will include 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education, and support.

placebo comparator: Control

The control (CL) will receive 6 months of texts for general health promotion.

Interventions

Intervention

6 months of diabetes management support via SMS texts including reminders for medication adherence, appointments, and diabetes self-care activities as well as education, and support

Attention Control

6 months of texts for general health promotion

Primary outcome measure

  • Change in HbA1c [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Ramin Asgary, MD, MPH

917-684-9331raminasgary1@gwu.edu

Leah Bauder, MPH

970-682-0940leahbaud@gwu.edu

Locations

George Washington University

Recruiting

Washington D.C., District of Columbia, United States, 20052

Contacts

Ramin Asgary, MD

2029946803raminasgary1@gwu.edu

Leah Bauder, MPH

leahbaud@gwu.edu

More Information

Sponsor

George Washington University

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • Diabetes
  • Homelessness
  • SMS text
  • mobile Health
  • Clinical trial
  • Health disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2026-01-14.