Gestational Diabetes MellitusPhase 4NCT05922033
Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)
A Phase 4 study testing Patient-led Insulin (intervention group) in people with Gestational Diabetes Mellitus and Pregnancy in Diabetic, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Pregnancy in Diabetic, Pregnancy, High Risk
- What is being tested?
- Patient-led Insulin (intervention group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to 1 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Type 1 or 2 diabetes
- Insulin allergy
- Not English or Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Being tested
- Patient-led Insulin (intervention group), Provider-led Insulin (standard care)
- Keywords
- Titration of insulin, Pregnancy, Glycemic control
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-led Insulin (intervention group)Drug
Also called 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.
Provider-led Insulin (standard care)Drug
Also called insulin
Individuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers.
| Study group | Role | What they receive |
|---|---|---|
| Patient-led self-titration of insulin | Experimental | 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. Receives: Drug: Patient-led Insulin (intervention group) |
| Standard of care | Active comparator | Individuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers. Receives: Drug: Provider-led Insulin (standard care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Secondary outcomes (17)
Birth weight in grams
continuous measure birthweight in grams of neonate of the pregnancy as recorded in the delivery record
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At birth
Preterm birth <37 weeks for any indication
categorical measure of the presence of delivery before 37 weeks either spontaneous or iatrogenic
Measured: 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
Measured: 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
Measured: At birth
Demographics and logistic barriers survey
continuous measure of survey from the demographics and logistic barriers survey
Measured: 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
Measured: 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
Measured: after the 36th week until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start19 Oct 2023
- Primary completion30 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kartik K Venkatesh, Ohio State University
- Investigators
- Kartik Venkatesh, MD, PhD, Principal investigator, Ohio State UniversityXiao-Yu Wang, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922033
- Sponsor's protocol ID
- 2023H0222
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047McGovern 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.
PubMed 35900879Bradley 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.
PubMed 17927832Polonsky 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.
PubMed 15735199Davies 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.
PubMed 36148880Wang XY, Grobman WA, Wu J, Suzawa R, Kralik J, Summerfield T, Vickers S, Widmayer B, Rainier M, Somppi J, Buccilla L, Iadicicco B, Buschur E, Gabbe S, Landon MB, Venkatesh KK. Patient-Led Insulin Titration for Glycemic Management With Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2026 Apr 1;147(4):501-509. doi: 10.1097/AOG.0000000000006154. Epub 2026 Feb 19.
PubMed 41712937
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT05922033
- Acronym / sponsor ID
- 2023H0222
- Keywords
- Titration of insulin, Pregnancy, Glycemic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-led self-titration of insulin | Experimental | 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. |
| Standard of care | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Type 1 or 2 diabetes
- Insulin allergy
- Not English or Spanish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-led Insulin (intervention group)Also: insulinIndividuals 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 self-titration of insulin |
| Provider-led Insulin (standard care)Also: insulinIndividuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers. | Drug | Standard of care |
Primary outcome
Fasting glycemic control
Time frame: 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.
17 secondary outcomes
Birth weight in grams
Time frame: At birth
Fasting blood glucose >50% at target within the past week
Time frame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Postprandial blood glucose >50% at target within the past week
Time frame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Average fasting blood glucose
Time frame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Average postprandial blood glucose
Time frame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Maternal hypoglycemia events
Time frame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Total insulin usage (units/kg/day)
Time frame: at time of delivery approximately from 36 weeks to 39 weeks gestation
Composite perinatal outcomes (large for gestational age, neonatal hypoglycemia, NICU admission)
Time frame: At birth
Neonatal hypoglycemia
Time frame: at birth until 24 hours birth
NICU admissions
Time frame: Any NICU admission for 48 hours or greater duration up to 2-3 months
Preterm birth <34 weeks for any indication
Time frame: At birth
Preterm birth <37 weeks for any indication
Time frame: At birth
Hypertensive disorder of pregnancy
Time frame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation
Large for gestational age
Time frame: At birth
Demographics and logistic barriers survey
Time frame: after the 36th week until delivery
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: after the 36th week until delivery
Diabetes Distress Screening (DDS) Scale
Time frame: after the 36th week until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- Background: PubMed 35900879McGovern 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.
- Background: PubMed 17927832Bradley 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.
- Background: PubMed 15735199Polonsky 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.
- Background: PubMed 36148880Davies 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.
- Derived from this study: PubMed 41712937Wang XY, Grobman WA, Wu J, Suzawa R, Kralik J, Summerfield T, Vickers S, Widmayer B, Rainier M, Somppi J, Buccilla L, Iadicicco B, Buschur E, Gabbe S, Landon MB, Venkatesh KK. Patient-Led Insulin Titration for Glycemic Management With Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2026 Apr 1;147(4):501-509. doi: 10.1097/AOG.0000000000006154. Epub 2026 Feb 19.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kartik Venkatesh, MD, PhD principal investigator
Ohio State University
Xiao-Yu Wang, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patient-led Insulin (intervention group) in people with Gestational Diabetes Mellitus and Pregnancy in Diabetic, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glycemic control (time frame: From randomization to delivery, which is approximately from 36 weeks to 39 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922033, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.