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71 Gestational Diabetes Trials Near You
Power is an online platform that helps thousands of Gestational Diabetes patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerMetformin vs Insulin for Gestational Diabetes
Columbus, Ohio
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.
This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Renal Disease, Major Fetal Malformation, Others
Must Be Taking:Glucose Control Medications
1572 Participants Needed
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.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Or 2 Diabetes, Others
Must Be Taking:Basal Insulin
56 Participants Needed
Postpartum Diabetes Screening for Gestational Diabetes
Columbus, Ohio
To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Gastric Bypass, Others
104 Participants Needed
Technology & Coaching for Diabetes in Pregnancy
Columbus, Ohio
The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c \<6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c \<6.5% in the third trimester compared to the standard care group
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Gestation >20 Weeks, No Smartphone, Others
124 Participants Needed
Continuous Glucose Monitoring for Gestational Diabetes
Cleveland, Ohio
The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:
(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Gestational Diabetes, Gastric Bypass, Diabetes, Others
Must Not Be Taking:Corticosteroids, Insulin, Metformin, Others
6000 Participants Needed
Exenatide for Gestational Diabetes
Pittsburgh, Pennsylvania
This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:First Trimester, Gastrointestinal Disease, Others
Must Not Be Taking:Hypoglycemic Agents
13 Participants Needed
Glucose Control for Gestational Diabetes
Pittsburgh, Pennsylvania
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Major Fetal Anomalies, Planned Cesarean
218 Participants Needed
Lifestyle Interventions for Gestational Diabetes
Indianapolis, Indiana
The goal of this study is assess the impact of a higher intensity dietary and activity counseling program to improve blood sugar control and reduce the chance of developing gestational diabetes (GDM) as compared to the current standard diet and activity counseling.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:14+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Multiple Gestations, Type 1 Or 2 Diabetes, Major Fetal Anomalies, Others
Must Not Be Taking:Metformin, Systemic Steroids
100 Participants Needed
Metformin for Pre-eclampsia Prevention in Type 1 Diabetes
Pittsburgh, Pennsylvania
Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Renal Insufficiency, Liver Disease, Others
60 Participants Needed
Intensive Glycemic Control for Gestational Diabetes in Overweight/Obese Women
Pittsburgh, Pennsylvania
This trial is testing if stricter blood sugar targets can help overweight and obese pregnant women with gestational diabetes have healthier pregnancies. By aiming for lower blood sugar levels, the study hopes to reduce complications for both mothers and babies. The trial will also check if this approach is safe and cost-effective.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Renal Disease, Fetal Anomalies, Others
Must Not Be Taking:Steroids
828 Participants Needed
This trial will test a new insulin pump that automatically adjusts insulin levels for pregnant women with type 1 diabetes. The goal is to see if this pump can better control blood sugar compared to current methods. This could help reduce complications for both mothers and their babies.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
94 Participants Needed
Postpartum Care Support for Gestational Diabetes and Hypertension
Chicago, Illinois
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Others
1500 Participants Needed
Insulin with or without Metformin for Gestational Diabetes
Charlottesville, Virginia
This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Metformin Allergy, Insulin Hypersensitivity, Hepatic Dysfunction, Kidney Disease, Others
Must Be Taking:Metformin
130 Participants Needed
Lifestyle Interventions for Gestational Diabetes
Chicago, Illinois
The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pre-existing Diabetes
978 Participants Needed
Personalized Nutrition Intervention for Gestational Diabetes
Hamilton, Ontario
This trial will assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load (as measured by the area-under-the curve glucose) in high-risk pregnancies of South Asian women. The intervention targets two at-risk individuals: mother and infant, "breaking the cycle" of maternal gestational dysglycemia, excess infant adiposity and insulin resistance, and CVD in both mother and baby. The findings of this study will be important in guiding future evidence-based recommendations and public health policies to manage gestational glycemia in pregnant women at risk of GDM.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Or 2 Diabetes, Hypertension, Poor English, Others
140 Participants Needed
Insulin Glargine vs NPH for Diabetes in Pregnancy
Maywood, Illinois
We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Insulin Pump, Others
Must Be Taking:Insulin
160 Participants Needed
Exercise for High Blood Sugar During Pregnancy
Knoxville, Tennessee
This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will:
1. Determine the effects of physical activity (PA) timing, specifically 30 minutes of moderate intensity walking or stepping in the morning (between 5am-9am, within 30-40 minutes of starting breakfast), versus late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on glucose across the 24-hour cycle.
2. Explore the potential effects of the timing of PA on sleep and mood state.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type I/II Diabetes, PCOS Meds, Others
Must Not Be Taking:Metformin, Corticosteroids, Antipsychotics, Others
36 Participants Needed
NDPP-NextGen for Diabetes Risk Reduction
Winston-Salem, North Carolina
The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy.
The main goals of the study are:
1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI
2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy
3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth
All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:
1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression
2. Body size measurements
3. Fasted blood draws
Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 39
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Long-acting Contraceptives, Others
403 Participants Needed
Donor Milk for Newborns
Toronto, Ontario
The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units. It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months. The Investigators will also explore whether the type of supplementation will positively affect measures of newborns' health, growth, behavior, feeding efficacy, and parental stress. Each participating infant born to a diabetic mother OR born small for his/her gestational age (\<2500 grams) is assigned at random to 2 groups. The groups are: 1) Donor milk: all babies in this group will receive pasteurized donor milk from a trusted milk bank. 2) Formula: all babies in this group will receive formula as a standard of care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:< 2
Key Eligibility Criteria
Disqualifiers:Other Study, Caregiver Change, Others
112 Participants Needed
Digital Health Interventions for Gestational Diabetes
Toronto, Ontario
Among women with GDM, the investigators will determine if a strategy of (1) a website-based information and motivational resource bank; (2) biosensor/ePlatform-based physical activity and GWG tracking; and/or (3) a health coach will lead to more favourably outcomes; namely, GWG closer to target, higher physical activity levels, better glycemic and blood pressure control, and lower incidence of LGA in offspring.
The current project is designed to assess feasibility and usability to inform the development of a large randomized controlled trial. The investigators will monitor the implementation process and examine patient-oriented outcomes, including perceptions of utility, challenges, and burden. These will be assessed through telephone-based in-depth interview.
Methodology / Study design This is a feasibility randomized controlled trial with a factorial design. The investigators will recruit women with a diagnosis of GDM between 20 and less than 32 weeks' pregnancy. All will receive access to a website resource bank with tips and resources to optimize physical activity and dietary intake a quality during pregnancy. In addition, they will be randomized to one of the four following groups: (1) No additional intervention; (2) ePlatform-based automated support combined with pedometer-based physical activity monitoring and digital scale-based weight monitoring; (3) weekly telephone calls with a health coach to discuss physical activity, eating, gestational weight gain; (4) combination of ePlatform and telephone calls from a health coach.
The investigators will evaluate recruitment rates, drop-out rates, women's perceptions of the strengths and limitations of the strategy, and ease and feasibility of outcome assessment. Assessments will be through in-clinic assessments, on-line questionnaires, clinic-based measures, mailed-in pedometers, and telephone-based interviews. Assessments will be at study entry and two to three weeks before the expected date of delivery or date of scheduled C-section. There will be a telephone-based interview at 12 weeks postpartum.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes Type 1 Or 2, Smokers, Multiple Pregnancy, Others
227 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
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ADHD PatientAge: 31
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
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Depression PatientAge: 51
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
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Obesity PatientAge: 58
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
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Paralysis PatientAge: 50
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
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Arthritis PatientAge: 78
Optimal Timing of Childbirth for Gestational Diabetes
Falls Church, Virginia
This study will conduct a randomized trial among women with gestational diabetes (GDM). Study of Pregnancy And Neonatal health (SPAN), TIMing of dElivery (TIME) is a randomized trial that will recruit up to 3,450 pregnant women with uncontrolled GDM and randomize the timing of their delivery. Women with GDM who are approached for the trial and are found eligible but do not consent to participating in randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the best time to initiate delivery for GDM-complicated deliveries (defined as the time when risk of illness and death for the newborn is the lowest) between 37-39 weeks.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
6450 Participants Needed
Postpartum Follow-Up Card for Enhancing Postpartum Care
Washington, District of Columbia
The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge.
The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated.
Trial Details
Trial Status:Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
240 Participants Needed
Reducing Artificial Sweeteners for Diabetes in Pregnancy
Washington, District of Columbia
The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Tobacco, Alcohol, Gastrointestinal Disorders, Others
Must Not Be Taking:Metformin, GLP-1 Agonists
324 Participants Needed
Lifestyle Intervention vs Metformin for Gestational Diabetes
Washington, District of Columbia
The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is:
Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes?
Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes.
Participants will:
* Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
* Track diet, physical activity, and weight using the Fitbit and Looseit! apps.
* Attend weekly online group sessions for the first 4 weeks, then biweekly sessions.
* If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study.
* If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication.
* Continue with biweekly group sessions or have regular check-in calls.
* If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study.
* Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm.
* At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Malignancy, Others
Must Not Be Taking:Weight Loss Medications
60 Participants Needed
DPP + Doula Support for Gestational Diabetes
Nashville, Tennessee
Black and White mothers have similar prevalence of gestational diabetes mellitus (GDM). However Black mothers are more likely to develop Type 2 Diabetes Mellitus (T2DM) after a diagnosis of GDM. Both GDM and Type 2 diabetes mellitus (T2DM) increase her cardiovascular risk. The post-partum period is an ideal time to employ preventative strategies to alter her lifetime health-course. Unfortunately, Black mothers are less likely to follow up post-partum and less likely to be informed of the connection between pregnancy complications such as GDM and cardiovascular risks.
The Diabetes Prevention Program (DPP) is the "gold standard" for lifestyle intervention to prevent T2DM in at risk patients. From the original trial of over 1,000 racially heterogenous participants, the DPP underperformed in Black women and can be improved upon. The investigators propose a randomized controlled trial entitled: Mobilizing doulas to empower black women in post-partum diabetes prevention. This program will follow the Diabetes Prevention Program (DPP) curriculum as outlined by the CDC using an online platform. However, this program will expand on the DPP's educational program and provide trained community-based health care workers i.e., "doulas divas" to administer post-partum support while the participants matriculate through the online DPP. Participants will be randomized to either DPP only for one year or DPP + doula divas for one year).
The investigators hypothesize that for Black participants with GDM, DPP+ doula divas program will have a completion rate superior to that of the DPP alone.
The investigators propose this randomized controlled clinical trial utilizing institution and community partnerships to increase the rates of completion of post-partum diabetes prevention program in at risk women: Black women with GDM. The investigators also will implement this culturally responsive approach with the goal of reducing T2DM in Black women. Our discoveries will be a forward leap in the quest to reduce cardiovascular risk contributed by GDM and T2DM that lead to maternal morbidity and mortality.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Preexisting Type 2 Diabetes, Non-black Race, Others
100 Participants Needed
Dietary Intervention for Preventing Pregnancy Complications
Milwaukee, Wisconsin
The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:
* Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?
* Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.
Participants in the standard of care will be asked to:
* Complete surveys
* Biometric screenings
Participants in the intervention group will be asked to:
* Complete surveys
* Biometric screenings
* Participate in weekly personal health coaching
* Receive and consume provided weekly meals.
Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Renal Disease, Bowel Disease, Others
Must Not Be Taking:Psychotropics, Corticosteroids
100 Participants Needed
Insulin Therapy for Gestational Diabetes
Milwaukee, Wisconsin
The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pre-gestational Diabetes, Others
416 Participants Needed
Nutrition Programs for Postpartum Recovery
Baltimore, Maryland
The goal of this clinical trial is to better understand how different strategies, timing, and enhancements to medically tailored food delivery will address structural inequities in the food environment, empower communities to sustain behavior change, and ultimately improve postpartum weight control to prevent type 2 diabetes-a potent contributor to disparate mortality among Black women.
The main aims of the study are:
* To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, Moveable Feast ENHANCED (a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery, customized for postpartum people, culturally customized for engagement and adherence, and food provision for dependents) versus MFeast Usual Care (prepared medically tailored foods only)
* To test sustainability and scalability.
Participants will:
* Respond to online surveys (supported by study team members via scheduled phone calls) via REDCap links shared before each study visit at baseline, 3, 6 months post-delivery after the baseline survey.
* Submit anthropometric data (i.e, weight) and information about laboratory results ( e.g. HgbA1C)
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Social Support, Dietary Needs, Stillborn, Mental Illness, Others
40 Participants Needed
Insulin Infusion versus Rotating Fluids for Diabetes
Danville, Pennsylvania
This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:14 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
114 Participants Needed
Health Coaching to Prevent Excessive Weight Gain during Pregnancy
Baltimore, Maryland
Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Severe Mental Illness, Others
Must Not Be Taking:Diabetes Medications
380 Participants Needed
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Frequently Asked Questions
How much do Gestational Diabetes clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Gestational Diabetes clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Gestational Diabetes trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Gestational Diabetes is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Gestational Diabetes medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Gestational Diabetes clinical trials?
Most recently, we added Lifestyle Interventions for Gestational Diabetes, Probiotics for Gestational Diabetes and Nutrition Programs for Postpartum Recovery to the Power online platform.
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