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The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes

NCT ID: NCT01648244

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Type II Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Computer-Assisted Decision Support

These providers will use the CADS program to treat their enrolled patients.

Group Type EXPERIMENTAL

Computer-Assisted Decision Support

Intervention Type OTHER

The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.

Interventions

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Computer-Assisted Decision Support

The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Walter Reed National Military Medical Center

FED

Sponsor Role lead

Responsible Party

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Alicia L. Warnock

Director, Diabetes Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert A Vigersky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

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Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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353757

Identifier Type: -

Identifier Source: org_study_id