The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes (CADS)
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|ClinicalTrials.gov Identifier: NCT01648244|
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : November 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes Mellitus||Other: Computer-Assisted Decision Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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.
- Change in A1c [ Time Frame: baseline, 12, 24, 36, and 48 months ]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".
- Major events [ Time Frame: ongoing ]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 ]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 ]Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
- Blood pressure [ Time Frame: baseline, 12, 24, 36, and 48 months ]Clinically significant or statistically detectable changes in BP
- Lipids [ Time Frame: baseline, 12, 24, 36, and 48 months ]Clinically significant or statistically detectable changes in lipid profile.
- Patient satisfaction with treatment [ Time Frame: basline and 48 months ]Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
- Quality of life [ Time Frame: baseline and 48 months ]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 ]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 ]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 ]The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648244
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Robert A Vigersky, M.D.||Walter Reed National Military Medical Center|