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Type 1 Diabetes Mellitus clinical trials

View clinical trials related to Type 1 Diabetes Mellitus.

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NCT ID: NCT03556631 Completed - Clinical trials for Type 1 Diabetes Mellitus

Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes

Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of live combined Bifidobacterium and Lactobacillus preparation on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

NCT ID: NCT03554590 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

DM1, Effects of Carbo-Counting on Glycemic Control

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

Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy. However, it may lead to weight gain and unhealthy eating habits. This study aims to compare glycemic control parameters, anthropometric measurements and dietary lifestyle in T1DM patients who practice CHO-counting, after attending a structured course to learn how to manage this tecnique, vs a control Group, in a follow up period of 2 years.

NCT ID: NCT03549104 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes

CBT
Start date: January 14, 2019
Phase: N/A
Study type: Interventional

All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control. Currently, no diabetes self-management programs specifically address how to cope with fear of hypoglycemia. The investigators propose to pilot test a fear reduction intervention (Fear Reduction Efficacy Evaluation [FREE]) and its effects on fear of hypoglycemia, diabetes self-management, glucose control, and glucose variability.

NCT ID: NCT03547440 Active, not recruiting - Clinical trials for Type 1 Diabetes Mellitus

T1DM Clinical Onset and Progression in Paediatric Population

Bioda
Start date: March 18, 2015
Phase:
Study type: Observational [Patient Registry]

Diabetes Mellitus Type I is the chronic metabolic disease of childhood with the highest incidence in developed countries. Over the past 10 years the incidence of diabetes has been increased especially in immigrants children. The objective of the investigator's project is to evaluate factors that influence the T1DM course in immigrant and Italian children through an analysis of the relationship between socio-cultural determinants, lifestyles and metabolic control. The study population will consist of 100 children with first diagnosis of T1DM divided into two cohorts (Italian and immigrant children). The project consists in a follow-up of 18 months from first visit and will include laboratory tests, two questionnaires and determination of a microbiological indicator of the microbiota and levels of 25-hydroxyvitamin D. The research hypothesis is that the two groups of study population show a different metabolic control of diabetes due to differences in access to care, compliance to therapy and type of nutrition.

NCT ID: NCT03547427 Terminated - Clinical trials for Type 1 Diabetes Mellitus

Glucagon Counterregulation in Type 1 Diabetes

Start date: May 20, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether the combination of insulin and pramlintide is better than insulin alone at helping the pancreas release glucagon in response to a low blood sugar episode. A secondary goal is to assess whether basal pramlintide will delay gastric emptying.

NCT ID: NCT03534193 Suspended - Clinical trials for Type 1 Diabetes Mellitus

Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes

Start date: April 17, 2017
Phase: N/A
Study type: Interventional

This is a prospective, randomized trial to evaluate the effectiveness of using educational modules accessed through a bedside tablet in patients newly diagnosed with Type 1 Diabetes as an adjunct to *standard Children's Hospital- Molly Center diabetes education in comparison to *standard Children's Hospital- Molly Center diabetes education. (standard diabetes education consists of paper based reading material and nursing education).

NCT ID: NCT03528174 Completed - Clinical trials for Type 1 Diabetes Mellitus

Single Hormone Closed Loop Study With PDT Sensor

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

The study described within this protocol is designed to test a single hormone closed-loop algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device for measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery. Subjects will undergo one all day closed loop study using insulin only. The closed loop insulin only system includes a Dexcom G5 transmitter, a Nexus 5 smart phone and two Tandem tslim pumps connected to two Pacific Diabetes Technologies glucose sensing cannulas. The closed loop system will be started after G5 2 hour sensor start-up with an IV catheter for frequent blood withdrawal for 10 hours.

NCT ID: NCT03513939 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouchâ„¢ for Clinical Islet Transplantation

Start date: February 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The Cell Pouchâ„¢ is a novel implantable device, that is transplanted with therapeutic cells such as insulin producing islets. This combination product is designed for the treatment of Type 1 Diabetes Mellitus (T1D) with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Upon implantation, the Cell Pouch is designed to form a natural environment, rich in tissue and microvessels for the transplant and function of therapeutic cells. The Cell Pouch is designed as a scaffold made of non-degradable polymers, formed into small cylindrical chambers which, when implanted against the abdominal muscle, becomes incorporated with vascularized tissue to the circumference of removable plugs within as early as two weeks as demonstrated in preclinical studies. After the tissue incorporation, the plugs are removed, leaving fully formed tissue chambers with central void spaces for the transplantation of therapeutic cells including Islets of Langerhans (islets). The Cell Pouch forms a natural environment, rich in microvessels that allows the transplanted islets to engraft. It is believed this engraftment will enable long-term survival and function of transplanted islets. This study aims to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch for the treatment of T1D in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. The study also aims to establish islet release criteria that accurately characterize the islet product and are predictive of clinical transplant outcomes into the Cell Pouch, which will be demonstrated through defined efficacy measures.

NCT ID: NCT03513874 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

Metformin Plus Insulin on Non-obese Autoimmune Diabetes

Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.

NCT ID: NCT03512236 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus

Start date: April 25, 2018
Phase: Phase 1
Study type: Interventional

This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.