Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes

Completed · Early Phase 1

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT01778751

Run by

VA Office of Research and Development

People needed

50

Starts

2013-12-01

Expected to finish

2014-12-01

Last updated by the study team

2016-01-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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• known pregnancy (patients becoming pregnant during the study will be withdrawn and referred to appropriate services)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.).

Where it is running

• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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