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

NCT01648244 | Completed DMC

• 1 other identifier: 353757
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes Mellitus

Keywords

DM, T2DM, Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Major events

  ongoing

• Other DM-related events

  ongoing

• Glucose measures

  baseline, 12, 24, 36, 48 months

• Blood pressure

  baseline, 12, 24, 36, and 48 months

• Lipids

  baseline, 12, 24, 36, and 48 months

Study Arms (1)

Computer-Assisted Decision Support

EXPERIMENTAL

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

Other: Computer-Assisted Decision Support

Interventions

Computer-Assisted Decision Support 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.

Computer-Assisted Decision Support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Robert A Vigersky, M.D.

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Diabetes Institute

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 24, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (1)