Early Phase 1
N=50
Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01778751 ↗Enrolled (actual)
50
Serious AEs
14.0%
Results posted
Jan 2016
Primary outcome: Primary: Diabetes Control — 10.7; 10.2; 10.3; 9.1 percentage of glycosylated hemoglobin — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Home Telehealth with Behavioral Education Component (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diabetes Control |
10.7; 10.2; 10.3; 9.1; 10.4; 9.1 | 0.012 sig |
| SECONDARY Diabetes Self Care |
49.8; 52.3; 53.7; 58.2; 52.6; 61.1 | 0.303 |
| SECONDARY Self-reported Medication Adherence |
17; 15; 11; 9; 9; 8 | 0.830 |
| SECONDARY Depressive Symptoms |
7.3; 6.9; 6.6; 5.5; 5.9; 6.7 | 0.428 |
Summary
This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care) offers a feasible, sustainable, and generalizable approach to managing Veterans with persistent poorly-controlled diabetes, which can be implemented using only existing Home Telehealth services.
Eligibility Criteria
Inclusion Criteria
- Veterans with type 2 diabetes managed for > 1 year at an eligible site (Durham, Raleigh, Greenville, or Morehead City) will be eligible for enrollment.
- We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values of > 9.0% during the past year with no readings of < 9.0% despite ongoing medical care) by reviewing electronic medical records and soliciting referrals from primary physicians.
Exclusion Criteria
- Exclusion criteria will include lack of telephone access or severe hearing/ speech impairment that would limit:
- telephone interaction
- metastatic cancer
- active psychosis documented in medical record
- active alcohol or substance abuse
- diagnosis of dementia
- known pregnancy (patients becoming pregnant during the study will be withdrawn and referred to appropriate services)
- documented seizure history
- documented history of severe complications of hypoglycemia (such as coma or seizure)
- documented refusal or inability to perform self-monitoring of blood glucose
- ongoing use of warfarin with prior history of major bleeding event
- Due to challenges with dose adjustment by phone, Veterans on continuous subcutaneous insulin infusion (insulin pumps) will not be eligible for this study.
- Due to challenges with regulations regarding testing supplies pts will need to be taking insulin (a few patients had enrolled prior to this change.).
Data sourced from ClinicalTrials.gov (NCT01778751). 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.