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Type 1 Diabetes clinical trials

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NCT ID: NCT02225379 Completed - Type 1 Diabetes Clinical Trials

Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia

Hypo-Sense
Start date: September 2014
Phase: N/A
Study type: Interventional

Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart & respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device. The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods The proposed study will be consisting of two main segments: The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer. The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events. During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced. The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events. During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).

NCT ID: NCT02206152 Completed - Type 1 Diabetes Clinical Trials

A Randomized Double Blinded Study to Examine the Use of N-acetyl Cysteine for the Prevention and Treatment of HAAF in Patients With Type 1 Diabetes

NAC for HAAF
Start date: February 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single center, double blind randomized cross over design trial that will compare the impact of N-acetyl cysteine (200 mg) vs. saline infusion during experimental hypoglycemia on day one on the responses to experimental hypoglycemia on day two. 18 participants will be studied twice, 8 weeks apart. On each occasion they will undergo a 2 hour hypoglycemic clamp (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the morning of day 2 and day 3. During the morning clamps, samples will be collected for later measurement of serum epinephrine levels, plasma and red blood cell NAC, cysteine, and glutathione concentrations and GSH/GSSG ratios (redox status), and participants will be asked to complete a hypoglycemia symptom questionnaire

NCT ID: NCT02199470 Completed - TYPE 1 DIABETES Clinical Trials

β-cell Function in Type 1 Diabetes May Not Be As Low As Presumed

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

Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve glycemic control and decrease complications and rates of mortality. However, it can be succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of β-cell function by determining fasting levels of C-peptide and those after meal stimulus.

NCT ID: NCT02190669 Completed - Type 2 Diabetes Clinical Trials

Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control

Start date: June 2014
Phase: N/A
Study type: Observational

This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.

NCT ID: NCT02189694 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

Start date: June 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 hormone: 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 pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp. The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

NCT ID: NCT02184676 Completed - Type 1 Diabetes Clinical Trials

T1D Risk Assessment in Kids With Relatives

TRAKR
Start date: May 28, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born from type 1 diabetic parents.

NCT ID: NCT02181127 Completed - Type 1 Diabetes Clinical Trials

Closed-Loop Glucagon Administration For Hypoglycemia Treatment

Start date: November 2014
Phase: N/A
Study type: Interventional

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes > 21 years old.

NCT ID: NCT02167243 Completed - Type 1 Diabetes Clinical Trials

A Reinforcement Approach to Improve Diabetes Management

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D. The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.

NCT ID: NCT02155855 Completed - Type 1 Diabetes Clinical Trials

Telemedicine for Adolescents With Insulin-dependent Diabetes

Start date: December 2014
Phase: N/A
Study type: Interventional

Investigators hope that providing patients and families with additional ways of communication with the diabetes care team will improve diabetes control.

NCT ID: NCT02137512 Completed - Type 1 Diabetes Clinical Trials

Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

CTR3
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time. The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not. At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.