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Hypoglycemia clinical trials

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NCT ID: NCT04053712 Completed - Type 1 Diabetes Clinical Trials

Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes

DHCL2019
Start date: July 16, 2019
Phase: Phase 4
Study type: Interventional

Despite recent pharmacological and technological advantages, hypoglycemia remains to be the key limiting factor in achieving optimal glycemic control in people with type 1 diabetes. State-of-the-art treatment for type 1 diabetes is insulin in pens or pumps that focus on reducing hyperglycemia after relative insulin deficiency e.g. after food intake. In recent years, we focused on adding low-dose glucagon to insulin therapies for the treatment and prevention of hypoglycemia - referred to as "dual-hormone treatment". We have shown that low-dose glucagon is efficient in treating mild hypoglycemia and that several factors may affect its glucose response. Our next step is to test whether the combined delivery of insulin and glucagon can improve glucose control in individuals with type 1 diabetes. In this proposal, we want to test the efficacy, safety and feasibility of a dual-hormone closed-loop system, also known as an artificial pancreas. The closed-loop system involves automatic infusion of glucagon and insulin based on continuous glucose measurements. The system will be tested in a 33-hour in-clinic study comparing the glucose control by the combined automatic delivery of insulin and glucagon with the automatic delivery of insulin-only. The study is performed at Steno Diabetes Center Copenhagen (SDCC) in collaboration with the Technical University of Denmark (DTU). We expect that the study will clarify whether low-dose glucagon added to insulin therapy can improve the glucose control in adults with type 1 diabetes. We believe that the utilization of glucagon will allow for a weight neutral optimization of glucose control, reduce risk of hypoglycemia and reduce disease burden that will reduce diabetes complications and cardiovascular diseases.

NCT ID: NCT04050553 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

Start date: February 24, 2020
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). The study is open to participants with type 2 diabetes. It will last about 42 weeks for each participant.

NCT ID: NCT04035993 Completed - Diabetes Clinical Trials

The HEADWIND-Study

HEADWIND
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

To analyse driving behavior of individuals with type 1 diabetes in eu- and progressive hypoglycaemia using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycemic driving patterns using machine learning neural networks (deep machine learning classifiers).

NCT ID: NCT04030312 Completed - Clinical trials for Neonatal Hypoglycemia

Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant

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

The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.

NCT ID: NCT04028960 Terminated - Type1diabetes Clinical Trials

IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase

Start date: October 23, 2019
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04026750 Terminated - Type 1 Diabetes Clinical Trials

Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Start date: September 15, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes

NCT ID: NCT04025762 Completed - Clinical trials for Type 1 Diabetes Mellitus

24/7 Closed-loop in Older Subjects With Type 1 Diabetes

DAN06
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The main objective of this open-label, multi-centre, randomised, crossover design study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living conditions is safer and more efficacious compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L (70 and 180 mg/dl) as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of human factor assessments, cardiac arrhythmias and objective sleep quality assessment will also be evaluated in this study.

NCT ID: NCT04020445 Completed - Hypoglycemia Clinical Trials

Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes

Start date: January 1, 2016
Phase:
Study type: Observational

This study examines prospectively the safety and efficacy of switching from multiple daily insulin injections (MDI) to once daily IDegLira (insulin degludec and liraglutide fix ratio combination), a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).

NCT ID: NCT04016155 Recruiting - Clinical trials for Diabetes With Diabetic Chronic Kidney Disease (Diagnosis)

Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetic Patients With Chronic Kidney Disease

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

This will be a single centre study at the Prince of Wales Hospital, Hong Kong. Patients will be identified from an existing registry of diabetes patients with CKD. Potential subjects will be identified from patients attending diabetes, general medical and renal clinics. Following informed consent, patients will undergo screening where baseline HbA1c, renal function will be measured along withcomprehensive medical and drug history to confirm eligibility. All eligible patients will be fitted with a blinded CGM (Medtronic iPro2 professional CGM) on week-1 for baseline glucose profiles for capturing baseline CGM profile. In case of blinded CGM sensor loss or malfunction, the sensor will be replaced once. Patients with at least 50% sensor data during the blinded wear period will proceed to randomization. At week 0, patients will be randomized to the flash glucose monitoring or SMBG. Both groups will receive standardised education on diabetes self-management, prevention and treatment of hypoglycaemia. This will be accordance with the usual practice at the study site. In the FGM group, patients will receive training on insertion, operation of the device with access to the device software for viewing of ambulatory glucose profiles. Patients will be advised to confirm blood glucose readings with SMBG in the event of hypoglycaemic symptoms, if FGM displays glucose <3.9mmol or in event of glucose instability. Patients randomized to the control group will perform SMBG using dedicated blood glucose meter at least twice daily. Blinded CGM will again be worn in both groups at week 16 for assessment of primary and secondary outcomes. Subjects will compete a hypoglycaemia diary for documenting symptomatic or asymptomatic hypoglycaemia during the study period. Questionnaires on hypoglycaemia unawarenesss, fear of hypoglycaemia and patient-reported outcomes will be completed at baseline, week 8 and week 16 in both groups.

NCT ID: NCT04011683 Completed - Type 1 Diabetes Clinical Trials

Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes

Hypo-Heart-1
Start date: December 1, 2018
Phase:
Study type: Observational

The investigators hypothesise that patients with type 1 diabetes have clinically relevant, but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or clinically significant fluctuations in plasma glucose.