Comparison of Glycemic Control With Smartphone Application

NCT05592860 | Completed

• 3 other identifiers: STUDY-20-01694FWA#00005656FWA#00005651
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in weight

  baseline and 3 month

• Change in Body Mass Index (BMI)

  baseline and 3 month

• Change in blood pressure

  baseline and 3 month

Study Arms (2)

Mobile application

EXPERIMENTAL

Mobile application to enter glucose level

Device: Mobile application

Daily Diary

PLACEBO COMPARATOR

Daily Diary to record glucose level

Behavioral: Daily Diary

Interventions

Mobile application DEVICE

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

Also known as: device related insulin adjustment

Mobile application

Daily Diary BEHAVIORAL

participants will use daily diary to record glucose level

Daily Diary

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Issac sachmechi, MD, FACE, FACP

  Icahn school of medicine Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Diabetes Center of Excellence

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: July 10, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)