Clinical trial NCT01648244: The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes
Official title: The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes Mellitus
Keywords: DM, T2DM, Diabetes
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2012-07-24
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.

Detailed description: The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.

Eligibility criteria: Inclusion Criteria:

* Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
* Absence of orders for deployment or permanent change of station
* Willingness to recruit up to 19 patients prior to randomization
* Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Exclusion Criteria:

* Specialist physicians
* Orders for deployment or permanent change of station
* Unwillingness to recruit up to 19 patients prior to randomization
* No prior experience with management of type 2 diabetes in adults
* Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Primary outcomes:
measure: Change in A1c
timeFrame: baseline, 12, 24, 36, and 48 months
Secondary outcomes:
measure: Major events
timeFrame: ongoing
measure: Other DM-related events
timeFrame: ongoing
measure: Glucose measures
timeFrame: baseline, 12, 24, 36, 48 months
measure: Blood pressure
timeFrame: baseline, 12, 24, 36, and 48 months
measure: Lipids
timeFrame: baseline, 12, 24, 36, and 48 months
measure: Patient satisfaction with treatment
timeFrame: basline and 48 months
measure: Quality of life
timeFrame: baseline and 48 months
measure: Degree of Acceptance
timeFrame: baseline and 48 months
measure: Acceptance of uploading data
timeFrame: baseline, 12, 24, 36, and 48 months
measure: Demographic variables
timeFrame: baseline and 48 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Robert A Vigersky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: