Clinical trial NCT05922033: Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)
Official title: Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Gestational Diabetes Mellitus
Pregnancy in Diabetic
Pregnancy, High Risk
Keywords: Titration of insulin
Pregnancy
Glycemic control
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

Compare glycemic control defined as the mean fasting glucose in the last week prior to term (36 weeks) between individuals randomized to patient-led (intervention) versus provider-led insulin titration (standard of care).

SECONDARY AIMS:

Secondary Aim 1: Compare the frequency of adverse pregnancy outcomes (cesarean delivery, preeclampsia, large for gestational age, and NICU admission) between individuals randomized to patient-led (intervention) versus provider-led insulin titration (standard of care).

Secondary Aim 2: Compare effect of concurrent metformin use on total daily insulin dose per kilogram at 36 weeks overall, and by patient-led (intervention) versus provider-led insulin titration.

Secondary Aim 3: Compare patient and provider satisfaction between patient-led (intervention) versus provider-led insulin titration.

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 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

Primary outcomes:
measure: Fasting glycemic control
timeFrame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Secondary outcomes:
measure: Birth weight in grams
timeFrame: At birth
measure: Fasting blood glucose >50% at target within the past week
timeFrame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
measure: Postprandial blood glucose >50% at target within the past week
timeFrame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
measure: Average fasting blood glucose
timeFrame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
measure: Average postprandial blood glucose
timeFrame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
measure: Maternal hypoglycemia events
timeFrame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
measure: Total insulin usage (units/kg/day)
timeFrame: at time of delivery approximately from 36 weeks to 39 weeks gestation
measure: Composite perinatal outcomes (large for gestational age, neonatal hypoglycemia, NICU admission)
timeFrame: At birth
measure: Neonatal hypoglycemia
timeFrame: at birth until 24 hours birth
measure: NICU admissions
timeFrame: Any NICU admission for 48 hours or greater duration up to 2-3 months
measure: Preterm birth <34 weeks for any indication
timeFrame: At birth
measure: Preterm birth <37 weeks for any indication
timeFrame: At birth
measure: Hypertensive disorder of pregnancy
timeFrame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
measure: Large for gestational age
timeFrame: At birth
measure: Demographics and logistic barriers survey
timeFrame: after the 36th week until delivery
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: after the 36th week until delivery
measure: Diabetes Distress Screening (DDS) Scale
timeFrame: after the 36th week until delivery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kartik Venkatesh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Xiao-Yu Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
citation: McGovern AP, Hirwa KD, Wong AK, Holland CJE, Mayne I, Hashimi A, Thompson R, Creese V, Havill S, Sanders T, Blackman J, Vaidya B, Hattersley AT. Patient-led rapid titration of basal insulin in gestational diabetes is associated with improved glycaemic control and lower birthweight. Diabet Med. 2022 Oct;39(10):e14926. doi: 10.1111/dme.14926. Epub 2022 Aug 8.
citation: Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57.
citation: Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
citation: Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022 Nov 1;45(11):2753-2786. doi: 10.2337/dci22-0034.