Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)
Gestational Diabetes Mellitus, Pregnancy in Diabetic, Pregnancy, High Risk
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring Titration of insulin, Pregnancy, Glycemic control
Eligibility Criteria
Inclusion Criteria: Pregnant individuals with a diagnosis of Gestational diabetes mellitus (GDM) between 20 0/7 to 31 6/7 - 32 6/7 weeks and requiring initiation of basal insulin initiation as determined by provider Patients not on insulin or insulin initiation within 7 days of consent and randomization ≥ 18 years old with the ability to give informed consent Diagnosed with GDM during pregnancy by a one-hour 50-gram glucose challenge test ≥200 mg/dL at greater than 20 weeks of gestation or two elevated values on a 3-hour or a 100-gram glucose tolerance test at greater than 20 weeks of gestation. English speaking Receiving prenatal care at OSU or an affiliated clinic where Electronic Health Records (EHR) can be accessed Exclusion criteria: Type 1 or 2 diabetes Insulin allergy Not English speaking
Sites / Locations
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Patient-led self-titration of insulin
Standard of care
Individuals randomized to this arm will initiate night-time insulin of 10 units. The type of basal insulin will be left to the discretion of the provider with levemir or glargine preferred over NPH. On day 0 of initiation of insulin, the patient will initiate night-time (or prior to sleep if alternate sleep schedule) insulin of 10 units (glargine, detemir, or NPH). Patient will check their fasting blood glucose in the morning and record their values. If the value is below 70 they will decrease their insulin dosage that night by 2 units; if the value is above 95 they will increase their insulin dosage that night by 2 units; and if the value is between 70 and 95, they will maintain the same insulin dosage that night. The patients will continue this algorithm for the remainder of the pregnancy. If the patient does not have a fasting blood glucose, the patient will maintain the dose of basal insulin at the prior dose.
Individuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers.