Active clinical trials for "Diabetes Mellitus"

The purpose of this study is to determine how Humulin-R regular insulin affects the body's ability to feel low blood sugar (hypoglycemia) when delivered intranasally compared to placebo in subjects with Type 1 Diabetes (T1D) with hypoglycemia awareness. The study will use continuous glucose monitoring (CGM) to collect this information. The study drug or placebo will be administered using an intranasal device.

The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment. It will test the hypothesis that Gla-300 is non-inferior to IDeg-100 with glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in Hemoglobin A1c (HbA1c) reduction, without an increased potential risk of hypoglycemia.

Breastfeeding has been associated with decreased obesity. However, this relationship is not as clear in children who have been exposed to GDM and the mechanisms involved are little known. The overall objective of the project is to study the mechanisms of breastfeeding on the growth of children in women who have had a GDM. More specifically, the project want to compare the macronutrient and hormone composition of breast milk of women with and without GDM. Investigators also want to associate the levels of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without DG and the growth of the child. A total of 60 women (30 with GDM and 30 without GDM) will collect breastmilk at 2 months postpartum.

PACE-It study is a non-blinded, mix-method randomized controlled trial within a single site. This study aims to test the feasibility of implementing a complex intervention comprising of a) a Primary Care Based integrated community care team delivery of person centered care, b) supported by a care co-ordination platform using a mobile application and its effectiveness in improving the glycemic control of patients living with Diabetes and have complex needs.

Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin alone or in combination with oral antidiabetic drugs (OADs). Secondary Objectives: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control. To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight. To evaluate the safety of once weekly injection of efpeglenatide.

The two main questions that this research study will answer: will a 16-week community-based diabetes prevention program for delivery to at-risk mothers and children in a Federally Qualified Health Center (FQHC) setting show (a) pre- and post-intervention improvements to Type 2 Diabetes risk factors in 60 mother-child dyads; (b) intervention vs. control improvements to T2D risk factors in 30 mother-child dyads; and (c) maintenance effects to changes to Type 2 Diabetes risk factors in 30 mother-child dyads; and based on the acceptability, adoption, relevance to FQHC and participants, feasibility, fidelity, program costs, and factors influencing sustainability of this program, can it be disseminated nationwide to other FQHC's? The investigators hypothesize that participants (a) will show improvements following the intervention to T2D risk factors, (b) in the intervention will show significant improvements to T2D risk factors in versus the controls, and (c) will maintain the benefits beyond the 16-week intervention. The investigators also predict that this program will meet criteria to be disseminated nationwide to other FQHC's.

Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on metformin alone or metformin in combination with sulfonylurea. Secondary Objectives: To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG), and change in body weight. To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG following a MMTT, change in FPG, and change in body weight. To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in systolic blood pressure (SBP) for all patients, and change in SBP for patients with baseline SBP ≥130 mmHg. To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.

The DECIDE program is a problem-solving curriculum used to help manage everyday problems when living with diabetes. The purpose of this project is to complete an in-depth review of the Decision-Making Education for Choices in Diabetes Every Day (DECIDE) curriculum, which is delivered in a group face-to-face setting. Using a task analysis process, the investigators will use the findings from the review to develop a web-site version.

This is a randomized controlled feasibility trial for women diagnosed with gestational diabetes mellitus (GDM). The current front-line treatment for GDM is medical nutrition therapy (MNT), i.e. personalized diets which may or may not include mild carbohydrate restriction. Use of carbohydrate restriction increases the risk of the mother developing ketosis, a harmful condition for both the mother and fetus. If MNT is not enough to stabilize blood sugar levels, then pharmaceuticals are prescribed. In patients with type-2 diabetes and prediabetes, the carbohydrate-last food order behavior has been shown to improve post-meal blood sugar control without the need of reduced carbohydrate intake. Given this data, the addition of this intervention to MNT in patients with GDM may be helpful in achieving controlled blood sugar levels without increasing the risk of ketosis. This study will include two randomized groups diagnosed with GDM. Patients in the control group will be prescribed standard MNT. Patients in the intervention group will have identical MNT but with additional food order instruction/therapy. All patients will be followed up with at 1-2 week intervals. At each follow-up the physician and dietician will analyze the patient's blood sugar measurements and, among additional factors, determine if pharmaceuticals should be added. Treatment will continue through delivery. The primary aim of this study is to assess the feasibility of the carbohydrate last food order in GDM and generate preliminary data on its effects on glucose control.

This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.