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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
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".
Time frame: baseline, 12, 24, 36, and 48 months
Major events
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.
Time frame: ongoing
Other DM-related events
Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
Time frame: ongoing
Glucose measures
Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
Time frame: baseline, 12, 24, 36, 48 months
Blood pressure
Clinically significant or statistically detectable changes in BP
Time frame: baseline, 12, 24, 36, and 48 months
Lipids
Clinically significant or statistically detectable changes in lipid profile.
Time frame: baseline, 12, 24, 36, and 48 months
Patient satisfaction with treatment
Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
Time frame: basline and 48 months
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Quality of life
Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.
Time frame: baseline and 48 months
Degree of Acceptance
The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
Time frame: baseline and 48 months
Acceptance of uploading data
The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.
Time frame: baseline, 12, 24, 36, and 48 months
Demographic variables
The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.
Time frame: baseline and 48 months