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Pregnancy in Diabetics clinical trials

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NCT ID: NCT03320694 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Start date: February 1, 2016
Phase: Phase 3
Study type: Interventional

Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.

NCT ID: NCT03305939 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Lifestyle Intervention IN Gestational Diabetes (LIVING)

LIVING
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Investigators have taken the learning from various programs to develop a new lifestyle program (LIVING) that has a high probability of being feasible, acceptable and cost-effective in the South Asian context for women with prior Gestational Diabetes Mellitus (GDM). Investigators will optimize this intervention using an iterative, systems-based and user-centered approach. The intervention will be delivered by auxiliary nurse midwives or their equivalent in each participating hospital, representing a strategy of within-system task-shifting to augment scalability and sustainability. Investigators will then evaluate this in a Randomised Controlled Trial (RCT) to determine whether it will reduce the incidence of Type 2 Diabetes Mellitus (T2DM), in a manner that is affordable, acceptable and scalable. This project focuses on generating new knowledge around implementation of a preventive strategy embedded within existing health systems, using mixed-methods evaluation to inform on cost-effectiveness, acceptability and scalability. It represents a case study into "Integrated Innovation TM" incorporating a science component (a program based on behavior change theory that supports a multi-level approach to prevention by combining individually targeted strategies with social support), a social component (an innovative workforce strategy) and a sustainability component (a systems perspective for integration with existing health system infrastructure).

NCT ID: NCT03266133 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes

Start date: November 27, 2017
Phase: N/A
Study type: Interventional

This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.

NCT ID: NCT03240874 Completed - Clinical trials for Diabetes Mellitus in Pregnancy

SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women

Start date: August 2, 2017
Phase: N/A
Study type: Interventional

Diabetes during pregnancy is a challenging clinical situation requiring substantial patient engagement. The investigators have developed a novel early-phase tool, called SweetMama, that incorporates educational, motivational and supportive elements to positively impact maternal health behaviors. This phase of work involves develop an optimized version of SweetMama via a 2-step sequential process of in-depth usability and feasibility testing. First the investigators will conduct focus groups and individual usability testing followed by refinement of SweetMama based on participant input. Next, the investigators will conduct feasibility testing via a pilot randomized trial to determine acceptability, feasibility, and pilot procedures for a fully powered larger trial.

NCT ID: NCT03240289 Completed - Clinical trials for Gestational Diabetes

Texting for Diabetes Success in Pregnancy

Start date: December 2013
Phase: N/A
Study type: Interventional

Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a pregnancy complicated by diabetes.

NCT ID: NCT03229161 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus

Start date: January 3, 2017
Phase: N/A
Study type: Interventional

It is well-known that regular physical activity (PA) can improve glycemic control and physical fitness in type 2 diabetes patients. However, studies examining the effects of PA in patients with gestational diabetes mellitus (GDM) are limited. Interval walking training (IWT) is a careful type of PA consisting of repeatedly cycles of 3 min. fast and slow walking. The investigators aimed to examine, if IWT is feasible as PA intervention for GDM patients, and to examine the effects of IWT on glycemic control, PA levels and physical fitness.

NCT ID: NCT03106870 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Start date: June 2016
Phase: N/A
Study type: Interventional

The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

NCT ID: NCT03029702 Completed - Clinical trials for Gestational Diabetes

Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

MATCh-GDM
Start date: February 28, 2018
Phase: Phase 4
Study type: Interventional

Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over 400,000 pregnant women in the United States each year. Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity. Because of this, experts recommend treatment focused on normalization of hyperglycemia to improve outcomes. However, providers have limited capacity to predict which treatment will achieve glycemic goals. This results in a choice based on provider and patient preference and a trial and error approach, which can create delays in glycemic control within the short (8-10 weeks) window between diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use of an individualized treatment approach. The overall goal of this project is to investigate an individualized treatment approach for GDM where treatment is based on each woman's GDM mechanism. The study will employ the same treatment in both arms, but choice of treatment will differ based on study arm (matched or unmatched to GDM mechanism).

NCT ID: NCT03028506 Completed - Clinical trials for Diabetes in Pregnancy

Meal Composition and the Influence on Pre-prandial Blood Glucose Values

Start date: January 2015
Phase: N/A
Study type: Observational

The purpose of the proposed study is to assess the distribution of carbohydrates and fat in the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The carbohydrate distribution and fat content of the meal will be compared to maternal glucose control, preprandial glucose levels, and the percentile for weight of the infant at birth. In addition, each meal and snack will be classified as low-moderate fat or high fat.

NCT ID: NCT02979756 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Improve Detection and Management of Gestational Diabetes Through the Primary Health Care Level in Morocco

Start date: November 14, 2016
Phase: N/A
Study type: Interventional

A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in receiving appropriate care. Based on the results of the situational analysis, the investigators developed this proposal in close collaboration with the Moroccan research group on gestational diabetes composed of representatives of the Ministry of Health, researchers, members of professional organizations and specialists in the domains of endocrinology, gynecology, neonatal health and nutrition. The investigators opted for an hybrid implementation effectiveness trial to evaluate both clinical effectiveness of the proposed screening and initial management strategy and its implementation at the first level of care. The objectives of this study are thus to evaluate the feasibility of a decentralized strategy of screening for GDM and the initialization of GDM treatment already through the primary level of care and to assess its potential for scaling-up. Specific objectives of this study are to augment universal access to screening and management of gestational diabetes and to increase the competencies of health care providers at first level health care facilities to detect, start initial treatment and to improve follow-up of affected women. By comparing active screening and treatment initiation through first line health facilities with the existing practices, the investigators would like to explore the effect of the new model on maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery complications and birth weight. The investigators will further assess the acceptability of screening and initial management of GDM through first line health services by health care providers and by pregnant women diagnosed with GDM and the impact of two different screening approaches on the lifestyle of affected mothers.