Comparison of Glycemic Control With Smartphone Application

Mount Sinai Health System

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: Daily Diary; Device: Mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT05592860

FWA#00005656 (Other Identifier)

FWA#00005651 (Other Identifier)

STUDY-20-01694

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Mobile application

Experimental group

Description:

Mobile application to enter glucose level

Treatment:

Device: Mobile application

Daily Diary

Placebo Comparator group

Description:

Daily Diary to record glucose level

Treatment:

Behavioral: Daily Diary