Phase 3
N=244
Improving Insulin Therapy With Enhanced Care Management
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00320112 ↗Enrolled (actual)
244
Serious AEs
1.2%
Results posted
Nov 2014
Primary outcome: Primary: Change in Glycemic Control (HbA1c) — 8.02; 7.93; 7.73; 8.22 percent HbA1c — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Reciprocal Diabetes Peer Support Program (Behavioral); Nurse Case management (Behavioral); group outpatient counseling visits (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycemic Control (HbA1c) |
8.02; 7.93; 7.73; 8.22 | 0.004 sig |
| SECONDARY Change in Systolic Blood Pressure Measure |
140.3; 136.4; 136.9; 135.0 | .91 |
| SECONDARY Change in Diastolic Blood Pressure |
77.1; 75.8; 76.8; 76.1 | 0.10 |
| SECONDARY Number of Participants With Insulin Starts at 6 Months |
8; 1 | 0.02 sig |
Summary
VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services; many also lack social support to help them meet the demands of their illness. Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks, such as initiating or intensifying insulin treatment regimens. Although some VAs have implemented telephone nurse care management programs supported by automated calling services, many are reluctant to adopt these models due to nursing shortages.
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes
- HbA1c > 7%
- age > 21
Exclusion Criteria
- substance abuse disorder
- serious psychiatric illness
- serious hearing loss
- life expectancy < 12 months
Data sourced from ClinicalTrials.gov (NCT00320112). 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.