Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- HbA1c
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.
Detailed Description
The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.
Investigators
Issac Sachmechi
Director of Diabetes Center of Excellence
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •Adult type 2 diabetes mellitus patients (≥ 18years of age) whose HbA1c is ≥8% on insulin.
- •At least three months of daily home glucose monitoring before including in the study
- •Willing to provide consent to participate in the study
- •Uses a smartphone with cellular network and willing to and has ability to learn and use the Vivo vitals application on it.
Exclusion Criteria
- •Patients who have Gestational diabetes or type 1 diabetes
- •Patients who have been admitted to the hospital in the last month for more than 3 days.
- •Patients who have adrenal disorders or taking exogenous glucocorticoids.
- •Patients who are mentally incompetent, having uncontrolled psychiatric conditions, inmates.
- •Patients with active malignancies including those on treatment
Outcomes
Primary Outcomes
HbA1c
Time Frame: at the end of 3 months follow-up
A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well a person is controlling their blood sugar to help prevent complications from diabetes.
Secondary Outcomes
- Change in weight(baseline and 3 month)
- Change in Body Mass Index (BMI)(baseline and 3 month)
- Change in blood pressure(baseline and 3 month)