Use of a Computer-Assisted Decision Support (CADS) System in Management of Patients With Type 2 Diabetes
Status unconfirmed · Not applicable
Conditions studied: Diabetes Type 2
In brief
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.
Key facts
- Study ID
- NCT01382264
- Run by
- Walter Reed Army Medical Center
- People needed
- 570
- Starts
- 2011-07-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2011-06-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
- 18 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)
- Not taking or not expected to be taking any oral glucocorticoids except for replacement therapy for those with adrenal insufficiency, amphetamines, anabolic, or weight-reducing agents during the course of the study
- Not receiving chemotherapy or immunosuppressive therapy access to telephone capable of transmitting data for downloading of a glucose meter
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.
- Individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
Where it is running
- Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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