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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT05025852 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial

MiTy Tykes
Start date: May 11, 2022
Phase:
Study type: Observational

The incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy. There are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. Animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. This is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. We now have evidence from the MiTy trial, that offspring of metformin-exposed women with T2DM have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (SGA). These effects could lead to benefit or harm in the long-term. Offspring of MiTy mothers are currently being followed up to 2 years. Given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer. Goals/Research Aims:To determine whether in-utero exposure to metformin, in offspring of women with T2DM, is beneficial or harmful in the long-term. Research Questions: 1. In offspring of women with T2DM, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. What factors predict altered childhood adiposity and insulin resistance in these offspring? Primary Outcome: Body mass index (BMI) z-score. Secondary Outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment Expected Outcomes Given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.

NCT ID: NCT05023798 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Study to Evaluate a Prototype Non-Invasive BG Measurement System

ATD
Start date: September 15, 2021
Phase:
Study type: Observational

1. Diabetes mellitus is a chronic disease currently affecting more than 425 million people, of which one-third are people older than 65 years. In the UK, the number of people currently diagnosed with diabetes surpassed 3.8 million in 2019, with someone being diagnosed with the illness every two minutes (Diabetes.org figures). The prototype device being tested is a non-invasive blood glucose measurement system worn on the wrist. This would help people with diabetes manage their condition better and help prevent complications. 2. The main objectives of the research are: 1. To determine how accurate and effective the Afon prototype non-invasive blood glucose measurement system is, as compared to a gold standard invasive method. 2. To chart the Afon device's predicted blood glucose levels over time. 3. The study will be done with 30-50 patients. Eligible patients will have been diagnosed with diabetes (type 1 or 2) at least one year prior, be between 18 and 80 years old, and with a BMI between 18-35 kg/m2. For details of the full list of inclusion and exclusion criteria, see accompanying documentation. 4. The trial will be conducted at the Joint Clinical Research Facility (JCRF), Institute of Life Science 2, Swansea University, SA2 8PP. 5. Participants will attend the site for a total of 5 visits, one for screening, and four study visits, no more than 7 days apart. The study will run for one year.

NCT ID: NCT05022316 Active, not recruiting - Hypertension Clinical Trials

COHERE - COntextualized Care in cHcs' Electronic Health REcords

COHERE
Start date: September 12, 2022
Phase: N/A
Study type: Interventional

This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's primary outcomes are hypertension and diabetes control, but the results will have implications for a wide range of morbidities.

NCT ID: NCT05015894 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function

Start date: August 30, 2021
Phase: Phase 1
Study type: Interventional

Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in people with various degrees of reduced kidney function to the blood levels in people with normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants will only get the study medicine as two injections into a skinfold of participants belly (subcutaneous). The study will last for about 65 days including a screening phase of up to 28 days prior to dosing. If participants are eligible for the study, participants will have 11 visits to the study centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory visits (Visit 3 to Visit 11). Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood drawn, urine will be collected and electrocardiograms (ECGs) will be recorded.If participants are women and can get pregnant they cannot take part in the study. A hormone test will be done to check if participants may be post-menopausal.

NCT ID: NCT05015738 Completed - Diabetes Clinical Trials

Digital Tools for Learning Diabetes: Combination of Animation and Gamification

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

COVID-19, a global epidemic that affects the world, has created significant changes in many areas, especially in the health system. One of the most affected areas is nursing education. The content of nursing education focuses on cognitive, psychomotor and affective areas. In order for nursing education to be successful, important initiatives should be provided in the education of these areas. However, difficulties were encountered in the distance education process. This study was conducted to evaluate the delivery of diabetes education in nursing with animation and gamification.

NCT ID: NCT05014789 Completed - Clinical trials for Diabetes Mellitus, Type 1

Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study

Start date: August 19, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.

NCT ID: NCT05014204 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes

REGENT-1-US
Start date: October 29, 2021
Phase: N/A
Study type: Interventional

This is a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin glucose-lowering medications.

NCT ID: NCT05013346 Recruiting - Type 1 Diabetes Clinical Trials

Characteristics of Young-onset Diabetes in Sub-Saharan Africa (YODA) Study

YODA
Start date: September 1, 2019
Phase:
Study type: Observational

Type 1 diabetes has been poorly characterised, with very sparse information available in the literature about the characteristics of the disease in Africa. Atypical young onset diabetes is often reported by clinicians in sub-Saharan Africa, including patients who have the phenotype of type 1 diabetes but do not appear to have an absolute insulin requirement. The onset of type 1 diabetes in many sub-Saharan African populations seem to occur at later ages (20s to 40s) than what is generally seen in Caucasian populations. The investigators seek to characterise young-onset insulin treated diabetes (clinically diagnosed type 1 diabetes) in sub-Saharan Africa;

NCT ID: NCT05013294 Completed - Diabetes Clinical Trials

Using mHealth (Mobile Health) to Optimize Glycemic Control in Adults With Type 2 Diabetes: Proof of Concept Study

mHealth
Start date: August 23, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the efficacy of a diet-related mHealth (mobile health) intervention on glycated hemoglobin among adults with type 2 diabetes. The study hypothesizes that using mHealth influences food literacy and dietary behavior and may result in a reduction of glycated haemoglobin (HbA1c) by at least 0. 3% in 12 weeks in adults with type 2 diabetes. This study will be conducted in Nakuru County, a cosmopolitan county located in Northwestern Kenya. Participants will be eligible to be included in the study if they will meet the following criteria: (i) adults over the age of 18 years; (ii) diagnosed with type 2 diabetes in the previous 1 year and obtaining care at a participating level 4 hospital; (iii) able to read and write English or Swahili Language; (iv) currently own and able to read and send mobile text messages using any phone. Participants will be excluded if they are on dialysis or pregnant. The primary outcome measure will be HbA1c, which shall be measured at baseline and at the end of the intervention. Secondary outcome measures will include fasting plasma Glucose (FPG), total cholesterol (TC), triglycerides (TG) and high-density lipoprotein-cholesterol (HDL-C). Other secondary outcome measures will include anthropometric measurements (weight, height, waist and hip circumferences) and behaviour change (changes in dietary intake of legumes, fruits and vegetables). Additionally, mHealth satisfaction shall be assessed at 12 weeks and 24 weeks post-intervention to assess the sustainability of the intervention.

NCT ID: NCT05013229 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.