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Hypoglycemia clinical trials

View clinical trials related to Hypoglycemia.

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NCT ID: NCT05395000 Completed - Clinical trials for Diabetes Mellitus, Type 1

Comparison of Ease of Use and Acceptability of Intranasal and Injectable Glucagon Among Providers Administering it to Children or Adolescents With Type 1 Diabetes (BETTER-ING)

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

Background : The benefits of good glycemic control are clearly established. However, achieving glycemic targets comes at the expense of the risk of hypoglycemia. Repeated episodes of severe hypoglycemia can affect long-term cognitive function, especially in developing brains. Fear of hypoglycemia, both in children and their parents, has an impact on participation in physical activity, quality of life and optimal diabetes control. During an episode of severe hypoglycemia, i.e., when accompanied by severe cognitive dysfunction requiring assistance from others, it is impossible to administer oral glucose. Glucagon administration is particularly useful in this situation, as it rapidly raises blood glucose levels and restores consciousness. Injectable glucagon was the only form approved in Canada prior to 2019. A new formulation of glucagon for intranasal administration has recently been approved by Health Canada. The arrival of this formulation seems promising because of its ease of use while ensuring similar efficacy to injectable glucagon. Furthermore, the ease of learning how to use each of the devices through a simple multimedia tool is unknown. Indeed, current studies have not focused on a virtual teaching method. The latter is of particular interest in the context of a pandemic and in order to make information more accessible to a broader population that may not be present at family glucagon education (e.g., school-based caregivers). Objective : Compare the performance (time to prepare and administer, success rate) of the intranasal versus injectable glucagon administration procedure after a short video training 3 months earlier among parents/primary caregivers and school workers who may administer glucagon to children with type 1 diabetes. Secondary objectives : 1. To assess stakeholder administration procedure preferences for the two glucagon formulations in the two groups ; 2. To explore the barriers and emotional impact (fears, perceptions, stress, etc.) related to the use of intranasal and injectable glucagon in both groups; 3. Explore the participants' preferences in relation to the teaching method of administering the two forms of glucagon.

NCT ID: NCT05379686 Recruiting - Type 1 Diabetes Clinical Trials

Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

The HYPO-AVOID
Start date: September 21, 2022
Phase: N/A
Study type: Interventional

The primary aim of the study is to evaluate the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise in individuals with AHCL-treated T1D.

NCT ID: NCT05378672 Recruiting - Hypoglycemia Clinical Trials

A Study to Inv. Safety,Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children<6 Years With T1D

Start date: May 9, 2023
Phase: Phase 3
Study type: Interventional

This research study will investigate whether dasiglucagon as a rescue therapy for participants between 1 and 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics). Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.). Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

NCT ID: NCT05331469 Recruiting - Clinical trials for to Identify Which Titration Regimen of Basal Insulin (Being Daily Titration vs 3 Daily Titration) is Better in Reducing hba1c and Have Lesser Hypoglycemia

Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.

Start date: July 19, 2021
Phase: Phase 4
Study type: Interventional

Introduction Diabetes mellitus is a worrying global non-communicable disease where it is affecting 18.3% of Malaysian adults. Poorly managed diabetes leads to an array of serious complications, namely heart attack, kidney failure and stroke. Insulin therapy remains one of the most important medication in treating diabetes especially in the population with high sugar readings or long standing diabetes. Outpatient consultations for T2DM patients are spaced out due to the limited amount of treating physicians and clinic time. This resorts to the importance of outpatient patient-lead insulin titration. Different guidelines from local and international showed different basal insulin titration method in achieving ideal fasting blood sugar. Objective We aim to investigate the difference of basal insulin titration methods in reducing HbA1c among the T2DM patients. Methodology In a parallel group randomized controlled trial, we aim to recruit 70 adult T2DM patients who have poorly controlled T2DM ( HbA1c > 7.5% with FPG >8mmol/L) or newly diagnosed T2DM patients (who are symptomatic or HbA1c >10% or FPG >13 mmol/L). The subjects will be randomized to 2 groups, daily basal insulin titration and 3 daily basal insulin titration. These subjects will be follow up for 12 weeks (4th week and 8th week virtual consultation and 12th week face-to-face consultation). The primary outcome is the HbA1c reduction from baseline to the end of 12weeks intervention. The secondary outcomes are percentage of T2DM patients achieving fasting blood sugar within 4.4-7mmol/L and/or HbA1c <7% within the study period, the incidence of hypoglycemia, total daily basal insulin dosage required to achieve desired fasting blood sugar, duration taken to achieve desired fasting blood sugar, weight changes and satisfaction to the therapy between the 2 intervention groups. Clinical Significance This study enables us to evaluate the efficacy of the different basal insulin titration methods among the T2DM patients.

NCT ID: NCT05317455 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 1

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Start date: January 2024
Phase: Early Phase 1
Study type: Interventional

This is a prospective randomized placebo-controlled double-blind crossover study determining the effect of dichloroacetate on brain glucose metabolism under clamped hypoglycemia in T1DM.

NCT ID: NCT05310292 Active, not recruiting - Clinical trials for Idiopathic Ketotic Hypoglycemia

A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia

IKH_MetEx
Start date: March 21, 2022
Phase: N/A
Study type: Interventional

The project will evaluate 1) the postprandial metabolism and 2) continuous glucose levels in subjects diagnosed with Idiopathic Ketotic Hypoglycemia (IKH)) and healthy control subjects.

NCT ID: NCT05308095 Completed - Diabetes Clinical Trials

The HEADWIND Study - Part 4

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia while driving in a real car. Based on the in-vehicle variables, the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycaemic driving patterns using machine learning classifiers.

NCT ID: NCT05263310 Recruiting - Aging Clinical Trials

Prepare for Your Diabetes Care

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

As adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). This study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in value-aligned re-assessment of diabetes treatment regimens with their primary care team. If the aims of this project are achieved and incidence of clinically-significant hypoglycemia is reduced, this Prepare for Your Diabetes web-based patient educational care strategy could be scaled and applied in a wide variety of healthcare settings and chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.

NCT ID: NCT05250271 Completed - Clinical trials for Roux-en-Y Gastric Bypass

Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 2

PBH Forecast
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

The overall aim of this study is to develop a sustainable hypoglycemia correction strategy.

NCT ID: NCT05221359 Recruiting - Type 1 Diabetes Clinical Trials

Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes

Pilot'Ex
Start date: May 5, 2022
Phase: N/A
Study type: Interventional

First in Human, pilot investigation An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients with Poorly Controlled Type 1 Diabetes with High Glucose Fluctuations, Prone to Severe Hypoglycemia