Type II Diabetes Mellitus
Conditions
Keywords
DM, T2DM, Diabetes
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.
Detailed description
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.
Interventions
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.
Sponsors
Walter Reed National Military Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1c | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other DM-related events | ongoing | Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits. |
| Glucose measures | baseline, 12, 24, 36, 48 months | Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions |
| Blood pressure | baseline, 12, 24, 36, and 48 months | Clinically significant or statistically detectable changes in BP |
| Lipids | baseline, 12, 24, 36, and 48 months | Clinically significant or statistically detectable changes in lipid profile. |
| Major events | 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. |
| Quality of life | 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 | baseline and 48 months | The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire. |
| Acceptance of uploading data | 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 | 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. |
| Patient satisfaction with treatment | basline and 48 months | Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ. |
Countries
United States
Outcome results
None listed