Comparison of Glycemic Control With Smartphone Application

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05592860
• Other study ID #: STUDY-20-01694
• Secondary ID: FWA#00005656FWA#
• Status: Completed
• Phase: N/A
• Start date: July 10, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: October 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Mobile application
participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly

Behavioral:
• Daily Diary
participants will use daily diary to record glucose level

Locations

Country	Name	City	State
United States	Queens Hospital Center	Jamaica	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in weight	Change in weight	baseline and 3 month
Secondary	Change in Body Mass Index (BMI)	Change in BMI	baseline and 3 month
Secondary	Change in blood pressure	Change in blood pressure - systolic and diastolic	baseline and 3 month