Mobile App Logging for Diabetes in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OneTouch Reveal application.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes
Overview
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.
Interventions
- 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
Primary outcome measures
- Compliance [Time frame: 4 weeks]
Secondary outcome measures (1)
- Percentage of in-range blood glucose levels [Time frame: 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Augusta University — Augusta
Identifiers
NCT: NCT06005987 · 1992519