Comparison of Glycemic Control With Smartphone Application

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT05592860
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2021-07-10
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-02
• Status Verified: 2022-10
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Study First Posted: 2022-10-25
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	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 Outcome Measures

Name	Time	Method
Change in Body Mass Index (BMI)	baseline and 3 month	Change in BMI
Change in blood pressure	baseline and 3 month	Change in blood pressure - systolic and diastolic
Change in weight	baseline and 3 month	Change in weight

Trial Locations

Locations (1)

Queens Hospital Center; 🇺🇸 Jamaica, New York, United States