Mobile App Logging for Diabetes in Pregnancy | NCT06005987

Studies
Mobile App Logging for Diabetes in Pregnancy

NCT06005987

Sponsor

Carolyn Zahler-Miller

Status

Recruiting

Last Update Posted

Jan 31, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Gestational Diabetes Mellitus in Pregnancy
Type 2 Diabetes

Interventions

OneTouch Reveal application

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Aug 16, 2023

First Submission Date that Met QC Criteria

Aug 16, 2023

First Posted Date

Aug 23, 2023Actual

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

Jan 29, 2025

Last Update Posted Date

Jan 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carolyn Zahler-Miller, Associate Professor, Augusta UniversitySponsor-Investigator

Lead Sponsor

Carolyn Zahler-MillerOTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.

Detailed Description

Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is often the first time they've had to keep such strict logs. Patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. Subjects will be recruited from the Augusta University downtown location obstetric clinics.

Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (GTT) > 200mg/dL or 3h GTT with 2 or more abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application to track blood sugar readings, and type 1 diabetes.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mobile App arm	Experimental	Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app	Behavioral: OneTouch Reveal application
Paper Log Arm	No Intervention	Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OneTouch Reveal application	Behavioral	Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compliance	percentage of actual blood glucose values logged compared to expected.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of in-range blood glucose levels	Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years and older
Verified intrauterine pregnancy
At least 12 weeks gestation
Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus.

Exclusion Criteria:

Patients with less than 4 weeks anticipated to be remaining in pregnancy
Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking
Type 1 diabetes mellitus
Non-English speaking patients

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Patients must be pregnant.

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rebecca Keipper, MD	Contact	7067212541		rkeipper@augusta.edu
Carolyn M Zahler-Miller, MD	Contact	7067212543		czahlermiller@augusta.edu

Overall Officials

Name	Affiliation	Role
Rebecca Keipper, MD	Augusta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Augusta University	Recruiting	Augusta	Georgia	30912	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

After study completion and for 2 years afterwards

Access Criteria

contact study PI

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Patients will be randomized to two arms. First is traditional logging of blood glucoses with standard paper form in the clinic. The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.

Masking Info

Masking

Single

Masking Description

Cannot mask participant who needs to use the mobile application, or their care provider, or the investigator who will need to teach the patient how to use the application.

Who Masked

Outcomes Assessor