Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Fasting glycemic control
研究概览
简要总结
We propose a pragmatic, unblinded, randomized controlled, single center trial of 56 pregnant individuals with Gestational diabetes mellitus (GDM). Our study proposes a pragmatic randomized control trial of patient led rapid titration of basal insulin compared to standard therapy. There is a planned subgroup analysis of patients with and without concomitant metformin usage. Patients will continue routine clinic visits. Patients who are initiated on basal insulin or started on night-time basal insulin within 7 days will be approached about the study. Patients who agree to be enrolled will sign informed consent.
详细描述
Gestational diabetes mellitus (GDM) is one of the most frequent medical complications of pregnancy and affects nearly 1 in 10 pregnant individuals. GDM is associated with an increased risk of adverse pregnancy outcomes for both the pregnant individual (cesarean delivery, preeclampsia) and infant (large for gestational age at birth, preterm birth <37 weeks, neonatal hypoglycemia, and hyperbilirubinemia). Improved glycemic control has been associated with reduction in the risks of these adverse pregnancy outcomes. Nearly 1 in 4 pregnant individuals with GDM will require medication to achieve glycemic control. The first-line therapy historically recommended for glycemic control is insulin and continues to be the primary recommendation of guidelines from the American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association (ADA). However current guidelines do not recommend a clear approach to insulin titration in GDM. This is an important limitation of current clinical practice. Individuals with GDM who are generally diagnosed between 24 to 28 weeks only have a short window of up to a few months to achieve glycemic control with pharmacotherapy to prevent adverse pregnancy outcomes. Traditionally, provider led titration of insulin has been the standard of care. Recommendations from outside of pregnancy and limited observational data from pregnancy have proposed patient-led self-titration of basal insulin have improved glycemic control compared to provider led titration.
We propose to conduct a pragmatic randomized controlled trial "EMPOWER: Patient versus provider-led titration of basal insulin for glycemic control in gestational diabetes" to compare pregnant individuals with GDM diagnosed >20 weeks gestation randomized to patient-led (intervention) versus provider-led insulin titration (standard of care).
OVERALL AIM: To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of patient-led insulin titration versus provider-led titration of basal insulin to improve glycemic control in the late third trimester in pregnancies complicated by gestational diabetes.
1.2 Specific Aims
PRIMARY AIM:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 or Spanish 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 or Spanish speaking
排除标准
- 未提供
研究组 & 干预措施
Patient-led self-titration of insulin
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.
干预措施: Patient-led Insulin (intervention group) (Drug)
Standard of care
Individuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers.
干预措施: Provider-led Insulin (standard care) (Drug)
结局指标
主要结局
Fasting glycemic control
时间窗: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Continuous measure of mean fasting glucose during the 36th week of pregnancy. Patients with have the mean fasting glucose value during the 36th week of pregnancy. We will use this goal given that inadequate glycemic control may be delivered as soon as the early term period (37-39 weeks) or patients may also have spontaneous or iatrogenic preterm delivery. If the patient delivers before the 36th week or does not have data available in the 36th week, we will use the last available week of data If the patient does not have glucose log in the 36th week, we will use the most proximal week such as the 37th week.
次要结局
- Birth weight in grams(At birth)
- Average postprandial blood glucose(From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation)
- Maternal hypoglycemia events(From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation)
- NICU admissions(Any NICU admission for 48 hours or greater duration up to 2-3 months)
- Preterm birth <34 weeks for any indication(At birth)
- Hypertensive disorder of pregnancy(From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation)
- Total insulin usage (units/kg/day)(at time of delivery approximately from 36 weeks to 39 weeks gestation)
- Diabetes Treatment Satisfaction Questionnaire (DTSQ)(after the 36th week until delivery)
- Composite perinatal outcomes (large for gestational age, neonatal hypoglycemia, NICU admission)(At birth)
- Fasting blood glucose >50% at target within the past week(From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation)
- Average fasting blood glucose(From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation)
- Demographics and logistic barriers survey(after the 36th week until delivery)
- Postprandial blood glucose >50% at target within the past week(From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation)
- Neonatal hypoglycemia(at birth until 24 hours birth)
- Preterm birth <37 weeks for any indication(At birth)
- Large for gestational age(At birth)
- Diabetes Distress Screening (DDS) Scale(after the 36th week until delivery)
研究者
Kartik K Venkatesh
Assistant Professor
Ohio State University