Mobile App Logging for Diabetes in Pregnancy

Sponsor

Carolyn Zahler-Miller (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06005987

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Mellitus in Pregnancy Type 2 Diabetes	Behavioral: OneTouch Reveal application	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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:

Single (Outcomes Assessor)

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.

Primary Purpose:

Treatment

Official Title:

Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mobile App arm 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 Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging
No Intervention: Paper Log Arm Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.

Arm

Intervention/Treatment

Experimental: Mobile App arm

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

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

No Intervention: Paper Log Arm

Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.

Outcome Measures

Primary Outcome Measures

Compliance [4 weeks]
percentage of actual blood glucose values logged compared to expected.

Secondary Outcome Measures

Percentage of in-range blood glucose levels [4 weeks]
Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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