Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)

Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, High Risk; Gestational Diabetes Mellitus; Pregnancy in Diabetic
• Intervention / Treatment: Drug: Patient-led Insulin (intervention group); Drug: Provider-led Insulin (standard care)

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Patient-led Insulin (intervention group); 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.; Other Names: insulin
Active Comparator: Standard of care; Individuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers.	Drug: Provider-led Insulin (standard care); Individuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers.; Other Names: insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glycemic control	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.	From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth weight in grams	continuous measure birthweight in grams of neonate of the pregnancy as recorded in the delivery record	At birth
Fasting blood glucose >50% at target within the past week	categorical measure of fasting BG at target. Fasting blood glucose at target (>95) in greater than 50% of recorded values with in the past week	From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Postprandial blood glucose >50% at target within the past week	categorical measure of fasting BG at target. Postprandial blood glucose >50% at target (<140 at 1 hour postprandial or <120 at 2 hour postprandial) within the past week	From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Average fasting blood glucose	Continuous measure of average fasting blood glucose. Average fasting blood glucose for each week of the pregnancy from randomization until delivery	From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Average postprandial blood glucose	Continuous measure of average postprandial blood glucose. Average fasting blood glucose for each week of the pregnancy from randomization until delivery	From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Maternal hypoglycemia events	Number of maternal hypoglycemia events defined as percent fasting glucose below 60	From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Total insulin usage (units/kg/day)	continuous measure total insulin usage at time of delivery	at time of delivery approximately from 36 weeks to 39 weeks gestation
Composite perinatal outcomes (large for gestational age, neonatal hypoglycemia, NICU admission)	categorical measure of the presence composite outcomes of large for gestational age, and neonatal hypoglycemia and NICU admissions of as a result of pregnancy.	At birth
Neonatal hypoglycemia	categorical measure if neonatal hypoglycemia is present as defined as blood glucose <35 mg/dL requiring glucose treatment in the first 24 hours of birth	at birth until 24 hours birth
NICU admissions	categorical measure if neonate is admitted to the neonatal intensive care unit for any indication at birth or until discharge of neonate	Any NICU admission for 48 hours or greater duration up to 2-3 months
Preterm birth <34 weeks for any indication	categorical measure of the presence of delivery before 34 weeks either spontaneous or iatrogenic	At birth
Preterm birth <37 weeks for any indication	categorical measure of the presence of delivery before 37 weeks either spontaneous or iatrogenic	At birth
Hypertensive disorder of pregnancy	categorical measure of the presence of the diagnosis of hypertensive disorder of pregnancy including gestational hypertension, preeclampsia with and without severe features, and superimposed preeclampsia, eclampsia, and HELLP syndrome as defined by ACOG guidelines	From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Large for gestational age	Categorical measure if neonate is large for gestational age as defined by 90th percentile for birthweight standardized by gestational age and sex	At birth
Demographics and logistic barriers survey	continuous measure of survey from the demographics and logistic barriers survey	after the 36th week until delivery
Diabetes Treatment Satisfaction Questionnaire (DTSQ)	continuous measure of survey information from Diabetes Treatment Satisfaction Questionnaire (DTSQ) assessing patients' satisfaction with their diabetes treatment	after the 36th week until delivery
Diabetes Distress Screening (DDS) Scale	continuous measure of survey Diabetes Distress Screening (DDS) Scale assessing the severity of the distress with living with gestational diabetes	after the 36th week until delivery

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Kartik Venkatesh, MD, PhD, Ohio State University; Principal Investigator: Xiao-Yu Wang, MD, Ohio State University

Publications and helpful links

General Publications

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Glycemic control; Titration of insulin
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus; Pregnancy in Diabetics; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2023H0222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No