Phase 2
N=38
Diabetes Homeless Medication Support
Diabetes Mellitus, Type 2 · Housing Problems · Psychological Distress
Bottom Line
View on ClinicalTrials.gov: NCT05258630 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Experience During the Intervention — 29.06; 28.22 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Diabetes Homeless Medication Support (D-Homes) (Behavioral); Enhanced usual care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hennepin Healthcare Research Institute
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Experience During the Intervention |
29.06; 28.22 | — |
| PRIMARY Retention in Assessments |
100; 89 | — |
| SECONDARY Change in Glycemic Control |
10.3; 10.4; 9.7; 9.6; 9.7; 9.6 | — |
| SECONDARY Psychological Wellness |
34.4; 39.8; 38; 37.6; 34.7; 36.7 | — |
| SECONDARY Diabetes Medication Adherence |
15.6; 17.2; 16.0; 16.7; 15.2; 16.1 | — |
Summary
This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.
Eligibility Criteria
Inclusion Criteria
- Age 18 yrs. or older
- English-speaking
- Homelessness by federal definition (HEARTH ACT) in the past 24 mos.
- Self-reported diagnosis of type 2 diabetes with A1c >7.5%, later verified in medical record and study point-of-care lab test.
- Plan to stay in local area or be reachable by phone for the next 24 weeks
- Willingness to work on medication adherence and diabetes self-care
Exclusion Criteria
- Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
- Active psychosis or intoxication precluding ability to give informed consent
- Pregnant or lactating people
Data sourced from ClinicalTrials.gov (NCT05258630). 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.