Use of a Computer-Assisted Decision Support (CADS) System in Management of Patients With Type 2 Diabetes

NCT01382264 | Unknown DMC

• 1 other identifier: 353757
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine whether the use of a computer assisted decision support (CADS)system by primary care providers (PCPs) for their patients with type 2 diabetes mellitus (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

Diabetes Type 2

Keywords

Poorly controlled diabetes Type 2; Computer Assisted Decision Support; Primary Care Providers

Outcome Measures

Primary Outcomes (1)

• Improved glycemic control as determined by A1C in a population of patients with inadequately controlled type 2 diabetes mellitus.

  The primary purpose of this 12-month, open, "cluster-randomized" trial study is to determine whether the use of a Computer Assisted Decision Support (CADS) System by primary care providers (PCPs) for their patients with type 2 diabetes mellitus (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.

  One year

Secondary Outcomes (4)

• Blood pressure

  1 year

• Lipid levels

  1 year

• Number of major and minor hypoglycemic episodes in the intervention and control groups.

  1 year

• Satisfaction with treatment and quality of life.

  1 year

Study Arms (1)

CADS

EXPERIMENTAL

Other: Computer Assisted Decision Support

Interventions

Computer Assisted Decision Support OTHER

Program to provide recommendations for achieving glycemic control in poorly controlled patients with T2 diabetes.

CADS

Eligibility Criteria

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

You may qualify if:

• Providers
• 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 below in Section 6.3.2.
• Patients
• Patients with a diagnosis of Type 2 DM of at least three months duration;
• History of inadequate glycemic control (A1C \< 7.0% but ≤ 11%) determined by at least two A1C values within the previous 6 months
• Willingness to test blood glucose four or more times each day at least once a week, and 8 times each day for one day per month;
• Willingness to upload their glucometer to transmit data to a central database every 2 weeks
• Access to a land line telephone in order to upload their glucometer data every 2 weeks
• Not using "prandial" regular or a short-acting insulin (e.g. insulin aspart, lispro, glulisine)
• Not using "premixed insulin" (Novolin Mix, Novolog Mix, Humulin Mix, Humalog Mix)
• years of age or older
• Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)

You may not qualify if:

• Providers
• 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 below
• Patients
• Patients with Type 1 diabetes or those with Type 2 on prandial rapid-acting insulin or premixed insulins
• Unwillingness to test blood glucose four or more times a day at least once a week and 8 times a day once a month;
• Unwillingness or inability to receive training in using the technology and/or upload blood glucose data every 2 weeks.
• No access to a land line telephone in order to upload their glucometer data every 2 week
• Inability to communicate in written and spoken English
• Organ (kidney, pancreas, liver) transplant recipients
• Severe impairment of dexterity, vision, or intellectual function
• Pregnancy verified by a urine pregnancy test at baseline in pre-menopausal women. The pregnancy test will be administered by the project officer at each study site.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead
• 59th Medical Wing: collaborator
• University of Hawaii: collaborator

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Robert A. Vigersky, MD

CONTACT

202.782.6750; robert.vigersky@amedd.army.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

US (1)