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Type 1 Diabetes clinical trials

View clinical trials related to Type 1 Diabetes.

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NCT ID: NCT01966393 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

Start date: April 2014
Phase: Phase 2
Study type: Interventional

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes. The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.

NCT ID: NCT01961622 Completed - Type 1 Diabetes Clinical Trials

Closing the Loop in Adults With Sub-optimally Controlled Type 1 Diabetes Under Free Living Conditions

AP@home04
Start date: April 2014
Phase: N/A
Study type: Interventional

The main objective of this study is to determine whether day and night closed-loop insulin delivery for 12 weeks under free living conditions is superior to addition of real-time continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control on insulin pump therapy. This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8 week run-in period, during which glucose control will be optimised by a professional pump educator, followed by two 3 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects usual insulin pump therapy augmented with real-time continuous glucose monitoring in random order. A total of up to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention arm will be replaced. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. Subjects will be discouraged from international travel during the first two weeks of closed-loop use. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.

NCT ID: NCT01954459 Terminated - Type 1 Diabetes Clinical Trials

Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?

Start date: September 2013
Phase: Early Phase 1
Study type: Interventional

This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.

NCT ID: NCT01945099 Completed - Type 1 Diabetes Clinical Trials

Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy

Start date: September 2013
Phase: Early Phase 1
Study type: Interventional

"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. Specifically, we will be looking to see if using hyaluronidase improves the ability of the closed loop artificial pancreas to better respond to meal related highs and lows.

NCT ID: NCT01941238 Completed - Type 1 Diabetes Clinical Trials

Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

Start date: July 2013
Phase: N/A
Study type: Observational

Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.

NCT ID: NCT01940835 Completed - Type 1 Diabetes Clinical Trials

Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

Start date: September 2013
Phase:
Study type: Observational

This purpose of this study is to determine if activation of a person's immune system in the small intestine could be a contributing cause of Type 1 Diabetes.

NCT ID: NCT01938807 Completed - Type 1 Diabetes Clinical Trials

Audio Health Engagement Analysis in Diabetes: The AHEAD Study

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

Despite multidisciplinary care and advancements in therapeutics and technology, health outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to poor outcomes is suboptimal diabetes management in pediatric patients and their families. The premise of this research project is that patients and families do not have adequate resources to meet the level of diabetes management that translates to better outcomes. Therefore, we will give them a valuable tool to improve their overall management. The tool is CareCoach. Research shows that enhancing communication and partnership among patients, parents, and providers is especially critical for optimal outcomes in pediatric diabetes. Communication gaps and conflict can complicate the already complex provider-patient interactions and daily management. We have therefore designed, refined, and made available to consumers a new mobile-based intervention, CareCoach, to improve communication; build trust among providers, patients and parents; and increase overall satisfaction with the quality of diabetes care. This web/mobile application is designed to help patients unobtrusively audio record their clinical encounters, track their medical consults and treatment plans, review information from past visits, create visit discussion guides, and track adherence to medication and dosing schedules. In addition, because mobile-based applications are inexpensive to administer, portable, and available at all times of day, CareCoach holds great promise for communication coaching and contributing to improved diabetes management. We hypothesize that CareCoach will improve patient-parent-provider communications, build patient-parent-provider trust, and increase overall satisfaction with clinical interactions in a sample of children with type 1 diabetes and their parents. These improvements will lead to significant gains in diabetes management, setting the stage for optimal health outcomes. To test the effectiveness of CareCoach, we will conduct a randomized controlled trial comparing the CareCoach intervention to standard care in a sample of 60 children with type 1 diabetes and their parents.

NCT ID: NCT01932476 Completed - Type 1 Diabetes Clinical Trials

Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

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

The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.

NCT ID: NCT01930110 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes

Start date: April 2014
Phase: Phase 2
Study type: Interventional

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise. The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.

NCT ID: NCT01930097 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes

Start date: August 2013
Phase: Phase 2
Study type: Interventional

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control. Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.