NCT06005987

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jun 2024Jan 2027

First Submitted

Initial submission to the registry

August 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

August 16, 2023

Last Update Submit

January 29, 2025

Conditions

Gestational Diabetes Mellitus in PregnancyType 2 Diabetes

Keywords

technology in medicinemobile applicationsblood glucose monitoringdiabetes in pregnancy

Outcome Measures

Primary Outcomes (1)

  • Compliance

    percentage of actual blood glucose values logged compared to expected.

    4 weeks

Secondary Outcomes (1)

  • Percentage of in-range blood glucose levels

    4 weeks

Study Arms (2)

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

OneTouch Reveal applicationBEHAVIORAL

Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging

Mobile App arm

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients must be pregnant.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes, Gestational

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Rebecca Keipper, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Keipper, MD

CONTACT

7067212541rkeipper@augusta.edu

Carolyn M Zahler-Miller, MD

CONTACT

7067212543czahlermiller@augusta.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 23, 2023

Study Start

June 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After study completion and for 2 years afterwards
Access Criteria
contact study PI

Locations

US(1)