N/A
N=200
Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus
Telemedicine
Bottom Line
View on ClinicalTrials.gov: NCT03520413 ↗Enrolled (actual)
200
Serious AEs
14.5%
Results posted
Jan 2023
Primary outcome: Primary: Hemoglobin A1c — 8.58; 9.19 % HbA1c — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRACTICE-DM (Other); Standard VA Home Telehealth (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
8.58; 9.19 | 0.02 sig |
| SECONDARY Diabetes Distress Scale |
1.43; 1.67 | 0.007 sig |
| SECONDARY Diabetes Self-Management Questionnaire |
8.34; 7.83 | 0.0002 sig |
| SECONDARY Perceived Competence Scale |
6.31; 5.92 | 0.02 sig |
| SECONDARY Body Mass Index |
35.05; 34.86 | 0.39 |
| SECONDARY Patient Health Questionnaire-8 |
4.64; 5.80 | 0.10 |
Summary
Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA's massive burden of diabetes complications and costs. VHA critically needs effective, practical management alternatives for Veterans whose diabetes does not respond to clinic-based management. The proposed study will address this need by leveraging VHA's unique Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans with persistently poor diabetes control despite clinic-based care. Because this intensive intervention is delivered using only existing Home Telehealth workforce, infrastructure, and technical resources - which are ubiquitous at VHA centers nationwide - it could represent an effective, practical approach to improving outcomes in Veterans with PPDM, potentially translating to a substantial reduction in VHA's diabetes burden.
Eligibility Criteria
Inclusion Criteria
- Veterans with persistently poorly-controlled type 2 diabetes mellitus defined as the presence of 2 HbA1c values 8.5% during the prior year (none 70
- life expectancy <5 years, or other comorbidities that would offset the benefits of HbA1c <8.5%
- inability to communicate by telephone
- dementia or psychosis
- active alcohol/substance disorder
- pregnancy
- prior hypoglycemic seizure/coma
- refusal to perform self-monitored blood glucose (SMBG)
- use of insulin infusion pumps
- hospitalized for stroke, heart attack or had surgery for blocked arteries in the past 12m
- receiving kidney dialysis
- metastatic cancer diagnosis
- use of a continuous blood glucose monitor (due to HT equipment constraints)
- primary provider requests patient not participate
Data sourced from ClinicalTrials.gov (NCT03520413). 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.