Clinical trial NCT06005987: Mobile App Logging for Diabetes in Pregnancy
Official title: Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Type 2 Diabetes
Keywords: technology in medicine
mobile applications
blood glucose monitoring
diabetes in pregnancy
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compliance
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentage of in-range blood glucose levels
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Rebecca Keipper, MD
role: PRINCIPAL_INVESTIGATOR
References: