Comparison of Glycemic Control With Smartphone Application

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Daily Diary; Device: Mobile application

• 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

Arm && Interventions

Group	Intervention	Description
Daily Diary	Daily Diary	Daily Diary to record glucose level
Mobile application	Mobile application	Mobile application to enter glucose level

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 weight	baseline and 3 month	Change in weight
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

Trial Locations

Locations (1)

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