Comparison of Glycemic Control With Smartphone Application

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Mobile application; Behavioral: Daily Diary

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Jamaica, New York, United States, 11432
      • Queens Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mobile application; Mobile application to enter glucose level	Device: Mobile application; participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly; Other Names: device related insulin adjustment
PLACEBO_COMPARATOR: Daily Diary; Daily Diary to record glucose level	Behavioral: Daily Diary; participants will use daily diary to record glucose level

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Issac sachmechi, MD, FACE, FACP, Icahn School of Medicine Mount Sinai

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2021
• Primary Completion (ACTUAL): December 2, 2021
• Study Completion (ACTUAL): December 2, 2021

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (ACTUAL): October 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: STUDY-20-01694; FWA#00005656 (OTHER: Department of Health and Human Services); FWA#00005651 (OTHER: Department of Health and Human Services)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee) identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to sachmeci@nychhc.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No