Program for the Prevention of <b>Diabetes</b> Mellitus Development in Women Who Had Already Experienced A <b>Gestational</b> <b>Diabetes</b>. Evaluation of the Efficacy of the Life-style Modification and the Life-style Modification in Conjunction With Metformin, in the Prevention of <b>Diabetes</b> Mellitus Development in a Population of Women Who Had Expired a <b>Gestational</b> <b>Diabetes</b> - a Multicenter, Randomized, Double Blind Study.
Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years. The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.
NCT00265746 — Type 2 Diabetes Mellitus
Status: Withdrawn
http://inclinicaltrials.com/type-2-diabetes-mellitus/NCT00265746/
Insights Into Glucose Variability Using Continuous Glucose Monitoring in Mothers With <b>Gestational</b> <b>Diabetes</b> Compared to Mothers at High Risk of <b>Gestational</b> <b>Diabetes</b> Who Have a Negative Oral Glucose Tolerance Test.
Gestational diabetes (GDM) develops during pregnancy and is becoming increasingly common. The condition is associated with adverse outcomes for mother and baby during both the pregnancy and delivery period. This study compares glucose variability (recorded by a continuous glucose monitoring (CGM) sensor) in pregnant women who have been diagnosed with GDM with pregnant woman who do not have the diagnosis but are at high risk. The sensors will be applied to 400 participants around the time of their standard test for GDM, with a randomly selected 60 of these patients forming a sub-group later in the study to assess for progression of high blood glucose. At present, a positive oral glucose tolerance test (OGTT) is used to confirm the diagnosis of GDM but the test can be unreliable leading to potential diagnostic error. CGM devices are used extensively in the management of Type 1 diabetes and GDM, and have also shown potential to be used in the diagnosis of Type 2 diabetes. If this study can demonstrate similar trends in glucose variability between OGTT positive patients and those who are OGTT negative but are at high risk for the condition, then further research into the utility of CGM as a diagnostic alternative or supplement to the OGTT would be indicated. The investigators will recruit 400 patients at high risk for GDM, give them a blinded CGM device, and compare the CGM glucose data with their OGTT result, their initial risk factors for GDM, their pregnancy outcome and their need for treatment. The investigators will use the data to test our hypothesis that a positive OGTT result does not predict hyperglycaemia in pregnancy.
NCT05981547 — Gestational Diabetes
Status: Recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT05981547/
<b>Gestational</b> <b>Diabetes</b> Mellitus: Does Early Screening and Treatment for Patients at Increased Risk for <b>Gestational</b> <b>Diabetes</b> Impact Perinatal Outcomes? A Randomized Controlled Trial
In the current study we aim to determine if early glucose screening and treatment among women at high risk for GDM improves perinatal outcome and decreases gestational weight gain. Half of the participant will be assigned to an early glucose screen group (12-18 weeks) and treatment if necessary and the other half to a standard 24-28 weeks glucose screen.
NCT02377531 — Gestational Diabetes
Status: Active, not recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT02377531/
Early Investigation of Glucose Monitoring After <b>Gestational</b> <b>Diabetes</b> (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After <b>Gestational</b> <b>Diabetes</b> Mellitus
One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.
NCT06184373 — Gestational Diabetes
Status: Not yet recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT06184373/
<b>Gestational</b> <b>Diabetes</b> and Pharmacotherapy (GAP) - A Randomized Controlled Trial Investigating Timing of Pharmacotherapy Initiation for Patients With <b>Gestational</b> <b>Diabetes</b>
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.
NCT03527537 — Gestational Diabetes
Status: Recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT03527537/
Effects of Telerehabilitation Exercise Program on Maternal Antenatal Glycemic Control in Women With <b>Gestational</b> <b>Diabetes</b>.
Gestational diabetes is in which high blood glucose concentration results from body's inability to create enough insulin to fulfil the needs of pregnancy. It appears in week between 24 to 28 and and raises the mothers and Childs risk of problems. It is thought to affect about 1 in 7 pregnancies worldwide. Through these remote exercise sessions the study evaluates the effectiveness of tele rehabilitation in improving glycemic management during pregnancy.The results will help clarify how telehealth intervention can best support GDM patient's maternal health outcomes.
NCT06452017 — Gestational Diabetes Mellitus in Pregnancy
Status: Not yet recruiting
http://inclinicaltrials.com/gestational-diabetes-mellitus-in-pregnancy/NCT06452017/
DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of <b>Gestational</b> <b>Diabetes</b>
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.
NCT06445946 — Gestational Diabetes Mellitus
Status: Not yet recruiting
http://inclinicaltrials.com/gestational-diabetes-mellitus/NCT06445946/
Nutrition Optimization and Community Upliftment for Postpartum Recovery: Interventions to Support Healing After <b>Gestational</b> <b>Diabetes</b>
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)
NCT06445530 — Gestational Diabetes
Status: Not yet recruiting
http://inclinicaltrials.com/gestational-diabetes/NCT06445530/
"Mantou" Screening for <b>Gestational</b> <b>Diabetes</b> Mellitus Before 20 Weeks of Gestation:A Prospective,Multicenter Study.
Gestational diabetes mellitus (GDM) can occur in overweight, hyperinsulinemia, insulin resistance pregnant women, or lean, insulin deficiency pregnant women. At least 5% of all pregnant women will develop GDM, which is even higher among Asians. Poor control of GDM in late pregnancy will increase the following risks: macrosomia, preeclampsia, shoulder dystocia, cesarean section, stillbirth and other risks. At present, the screening method for GDM is 75g of glucose OGTT test. However, when drinking sugared water on an empty stomach, the pregnant women will feel nausea, stomach burning, and hunger when waiting for blood drawing. Some women vomit after drinking sugared water, resulting in inaccurate test results and poor compliance, affecting the accuracy of diagnosis of GDM. "Sugar tolerance Mantou" has been used for screening diabetes since 1982. It is made of 100g flour and contains 75g glucose of the same amount. It is a feasible method to use Mantou instead of sugar powder to screen GDM. Mantou is an acceptable diet for Chinese people, which greatly reduces nausea, vomiting, hunger and other discomfort, and increases GDM screening rate. At present, the cesarean section rate in China remains high, and the weight and nutritional management of pregnant women are not satisfied. Many pregnant women, especially those in country-level areas, have already gained excessive weight when referred from to delivery hospitals, leading to an increase in pregnancy complications such as preeclampsia and macrosomia, increasing the cesarean section rate and delivery risk. Therefore, it is necessary to screen GDM in advance. Moving forward the screening of GDM and strengthening the management of pregnant women's weight can effectively reduce the occurrence of pregnancy complications.
NCT06436794 — GDM
Status: Not yet recruiting
http://inclinicaltrials.com/gdm/NCT06436794/
The Effect of SMS Counseling for <b>Gestational</b> <b>Diabetes</b> on Self-Efficacy and Knowledge Levels
The use of technology-based education and counseling services in the self-management of gestational diabetes contributes to better control of blood sugar levels, motivation and increased self-efficacy in women. Therefore, this study was planned as interventional research to determine the effect of SMS counseling given to individuals with gestational diabetes on self-efficacy and knowledge levels. This study was conducted descriptively with 95 patients with gestational diabetes who were treated in the endocrine service of a university hospital between August 15, 2021 and April 24, 2022. Personal information form created by the researchers, The Self-Efficacy Scale in Gestational Diabetes, and Diabetes Knowledge Scale were used to collect data.
NCT06436443 — Gestational Diabetes
Status: Completed
http://inclinicaltrials.com/gestational-diabetes/NCT06436443/