Comparison of Glycemic Control With Smartphone Application

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Mobile application
* Behavioral: Daily Diary


Participation Criteria
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Eligibility Criteria
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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 study4. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application<br>Mobile application to enter glucose level | Device: Mobile application<br>* participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly<br>* Other names: device related insulin adjustment;|
| Placebo Comparator: Daily Diary<br>Daily Diary to record glucose level | Behavioral: Daily Diary<br>* participants will use daily diary to record glucose level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | 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. | at the end of 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Change in weight | baseline and 3 month | 
| Change in Body Mass Index (BMI) | Change in BMI | baseline and 3 month | 
| Change in blood pressure | Change in blood pressure - systolic and diastolic | baseline and 3 month |