Comparison of Glycemic Control With Smartphone Application | NCT05592860

Studies
Comparison of Glycemic Control With Smartphone Application

NCT05592860

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Oct 25, 2022Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Mobile application
Daily Diary

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FWA#00005656	Other Identifier	Department of Health and Human Services
FWA#00005651	Other Identifier	Department of Health and Human Services

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2021Actual

Primary Completion Date

Dec 2, 2021Actual

Completion Date

Dec 2, 2021Actual

First Submitted Date

Oct 20, 2022

First Submission Date that Met QC Criteria

Oct 20, 2022

First Posted Date

Oct 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2022

Last Update Posted Date

Oct 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Issac Sachmechi, Director of Diabetes Center of Excellence, Icahn School of Medicine at Mount SinaiPrincipal Investigator

Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mobile application	Device	participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly	Mobile application

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in weight	Change in weight	baseline and 3 month
Change in Body Mass Index (BMI)	Change in BMI	baseline and 3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Issac sachmechi, MD, FACE, FACP	Icahn school of medicine Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queens Hospital Center		Jamaica	New York	11432	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All of the individual participant data collected during the trial, after deidentification.

Types

Study Protocol
Informed Consent Form (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.

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jul 9, 2021	Oct 19, 2022	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided