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OpenTrials
Completed

NCT Number: NCT05592860

Comparison of Glycemic Control With Smartphone Application

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.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queens Hospital Center

Jamaica, New York, 11432, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile application

Device

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

Daily Diary

Behavioral

participants will use daily diary to record glucose level

Primary outcomes

  1. HbA1c

    Time frame: 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 outcomes

  1. Change in weight

    Time frame: baseline and 3 month

    Change in weight

  2. Change in Body Mass Index (BMI)

    Time frame: baseline and 3 month

    Change in BMI

  3. Change in blood pressure

    Time frame: baseline and 3 month

    Change in blood pressure - systolic and diastolic

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2022
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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