Comparison of Glycemic Control With Smartphone Application

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-10

Study Completion Date

2021-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mobile application

Mobile application to enter glucose level

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

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

Daily Diary

Daily Diary to record glucose level

Group Type PLACEBO_COMPARATOR

Daily Diary

Intervention Type BEHAVIORAL

participants will use daily diary to record glucose level

Interventions

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Mobile application

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

Intervention Type DEVICE

Daily Diary

participants will use daily diary to record glucose level

Intervention Type BEHAVIORAL

Other Intervention Names

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device related insulin adjustment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No