Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01778751
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* known pregnancy (patients becoming pregnant during the study will be withdrawn and referred to appropriate services)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.).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01778751
Study Brief:
Protocol Section:
NCT01778751