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

Type II Diabetes Mellitus Clinical Trial

— CADS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648244
• Other study ID #: 353757
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: November 24, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1c	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".	baseline, 12, 24, 36, and 48 months	No
Secondary	Major events	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.	ongoing	Yes
Secondary	Other DM-related events	Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.	ongoing	Yes
Secondary	Glucose measures	Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions	baseline, 12, 24, 36, 48 months	No
Secondary	Blood pressure	Clinically significant or statistically detectable changes in BP	baseline, 12, 24, 36, and 48 months	No
Secondary	Lipids	Clinically significant or statistically detectable changes in lipid profile.	baseline, 12, 24, 36, and 48 months	No
Secondary	Patient satisfaction with treatment	Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.	basline and 48 months	No
Secondary	Quality of life	Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.	baseline and 48 months	No
Secondary	Degree of Acceptance	The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.	baseline and 48 months	No
Secondary	Acceptance of uploading data	The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.	baseline, 12, 24, 36, and 48 months	No
Secondary	Demographic variables	The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.	baseline and 48 months	No