Text Size

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

This study is currently recruiting participants.
Verified December 2012 by Walter Reed National Military Medical Center
Sponsor:
Information provided by (Responsible Party):
Robert Vigersky, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01648244
First received: July 17, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Type II Diabetes Mellitus
 Other: Computer-Assisted Decision Support

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Change in A1c [ Time Frame: baseline, 12, 24, 36, and 48 months ] [ Designated as safety issue: No ]
    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:
  • Major events [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
    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.

  • Other DM-related events [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
    Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.

  • Glucose measures [ Time Frame: baseline, 12, 24, 36, 48 months ] [ Designated as safety issue: No ]
    Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions

  • Blood pressure [ Time Frame: baseline, 12, 24, 36, and 48 months ] [ Designated as safety issue: No ]
    Clinically significant or statistically detectable changes in BP

  • Lipids [ Time Frame: baseline, 12, 24, 36, and 48 months ] [ Designated as safety issue: No ]
    Clinically significant or statistically detectable changes in lipid profile.

  • Patient satisfaction with treatment [ Time Frame: basline and 48 months ] [ Designated as safety issue: No ]
    Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.

  • Quality of life [ Time Frame: baseline and 48 months ] [ Designated as safety issue: No ]
    Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.

  • Degree of Acceptance [ Time Frame: baseline and 48 months ] [ Designated as safety issue: No ]
    The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.

  • Acceptance of uploading data [ Time Frame: baseline, 12, 24, 36, and 48 months ] [ Designated as safety issue: No ]
    The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.

  • Demographic variables [ Time Frame: baseline and 48 months ] [ Designated as safety issue: No ]
    The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer-Assisted Decision Support
These providers will use the CADS program to treat their enrolled patients.
 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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648244

Contacts
Contact: Mary Chellappa 301-319-2871 mary.chellappa@med.navy.mil
Contact: Susan Walker 301-319-2867 susan.walker@med.navy.mil

Locations
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Principal Investigator: Robert Vigersky, MD            
Sub-Investigator: Susan Walker, PhD            
Sub-Investigator: Mary Chellappa, MD            
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
Principal Investigator: Robert A Vigersky, M.D. Walter Reed National Military Medical Center
  More Information

No publications provided

Responsible Party: Robert Vigersky, Colonel, Medical Corp, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01648244     History of Changes
Other Study ID Numbers: 353757
Study First Received: July 17, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Walter Reed National Military Medical Center:
DM, T2DM, Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013