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

Not Applicable

Completed

• Conditions: Type II Diabetes Mellitus
• Interventions: Other: Computer-Assisted Decision Support

• Registration Number: NCT01648244
• Lead Sponsor: Walter Reed National Military Medical Center

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computer-Assisted Decision Support	Computer-Assisted Decision Support	These providers will use the CADS program to treat their enrolled patients.

Primary Outcome Measures

Name	Time	Method
Change in A1c	baseline, 12, 24, 36, and 48 months	Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".

Secondary Outcome Measures

Name	Time	Method
Glucose measures	baseline, 12, 24, 36, 48 months	Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
Patient satisfaction with treatment	basline and 48 months	Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
Quality of life	baseline and 48 months	Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.
Other DM-related events	ongoing	Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
Blood pressure	baseline, 12, 24, 36, and 48 months	Clinically significant or statistically detectable changes in BP
Major events	ongoing	The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.
Lipids	baseline, 12, 24, 36, and 48 months	Clinically significant or statistically detectable changes in lipid profile.
Degree of Acceptance	baseline and 48 months	The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
Acceptance of uploading data	baseline, 12, 24, 36, and 48 months	The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.
Demographic variables	baseline and 48 months	The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States