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Hypoglycemia clinical trials

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NCT ID: NCT03667053 Completed - Hypoglycemia Clinical Trials

Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin

NCT ID: NCT03665870 Completed - Diabetes Mellitus Clinical Trials

Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study aims to standardize and evaluate the benefits of the Prevention to Intervention program offered by the Birmingham Fire and Rescue Service. This will accomplished by standardizing the educational materials used, offering phone based follow-up and pre-post data collection.

NCT ID: NCT03656887 Completed - Diabetes Clinical Trials

Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

HAGED
Start date: January 8, 2019
Phase:
Study type: Observational

Diabetes is a major public health problem that has been growing steadily in recent years. Its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia. Hypoglycaemia in elderly diabetics has serious consequences: - increased mortality, - increased cardiovascular morbidity, - increased risk of falling, - impairment of quality of life. - Hypoglycaemia is also a risk factor for dementia in type 2 diabetes. The frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown. Elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. A study conducted in this population of patients showed that a third of them had HbA1C <6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available. We therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.

NCT ID: NCT03609632 Completed - Bariatric Surgery Clinical Trials

Understanding Hypoglycaemia After Bariatric Surgery

HYPOBAR1
Start date: September 20, 2018
Phase: N/A
Study type: Interventional

Postprandial hyperinsulinaemic hypoglycaemia is an increasingly recognized adverse side effect of bariatric surgery. Affected individuals experience low glucose levels 1-3 hours after intake of meals, accompanied by symptoms such as drowsiness, sweating, hunger and palpitations. Hypoglycaemia can be serious and have potential dangerous health impact (e.g. road accident or fall due to loss of consciousness). The pathophysiology is incompletely understood and more research is needed in search of preventive and therapeutic strategies.

NCT ID: NCT03605979 Completed - Type 1 Diabetes Clinical Trials

Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes

Start date: July 1, 2012
Phase:
Study type: Observational

Looking for strict normoglycemia in type 1 diabetes increases the risk of hypoglycemia, exposing to hypoglycemia unawareness. It has been shown that the early correction of hypoglycemia can help recovering the perception of hypoglycemia. The purpose of this prospective study was to assess the value of sensor-augmented insulin-pump therapy to treat hypoglycemia unawareness.

NCT ID: NCT03600116 Completed - Clinical trials for Type 1 Diabetes Mellitus

Collection of Breath and Sweat to Identify Indicators of Hypoglycemia

Start date: May 24, 2018
Phase:
Study type: Observational

Subjects with type 1 diabetes will be observed in the diabetes research center clinic following a meal and an insulin injection. Breath and sweat samples will be collected at intervals throughout the visit, with increased frequency during hypoglycemia. Collaborators with the MITRE Corporation will perform analyses on these samples to identify any relationships between volatile organic compounds in breath and sweat and hypoglycemia.

NCT ID: NCT03583268 Completed - Type 1 Diabetes Clinical Trials

Determining the Appropriate Intensity of Exercise to Prevent Post-exercise Hypoglycemia in Persons Living With T1D

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

Over 300, 000 youth and young adults across Canada are living with Type 1 Diabetes (T1D) which is considered the most common endocrine condition. Physical activity offers numerous health benefits however the majority of persons living with T1D are physically inactive, primarily due to fear of low blood sugar (hypoglycemia). This fear of hypoglycemia continues to exist for physically active persons with T1D as no established physical activity guidelines exist. Several acute studies have used high intensity interval training as a way to reduce the risk of hypoglycemia as it has the ability to activate fight or flight hormones which can raise blood sugar; however the intensity needed to elicit this response is unknown. The purpose of this project is to determine the acute effects of varying exercise intensities on the time spent in a low blood sugar range in 10 sedentary (VIGOR acute sedentary) and 16 physically active (VIGOR acute trained) individuals with T1D. Each participant will complete a maximal exercise test prior to the exercise sessions. Sedentary participants will complete 45 minutes of continuous moderate intensity exercise at 45-55% heart rate reserve (HRR) and three high intensity interval sessions with six one minute burst of high intensity at 70%, 80%, or 90% of HRR every four minutes. Active participants will complete 45 minutes of moderate intensity exercise at 45-55% of HRR and one high intensity interval session at 90% of HRR with intervals spaced every two minutes. The investigators will track the blood sugar response to exercise using a device called a continuous glucose monitor (CGM) which records blood sugar every five minutes over a period of six days. The CGM will help determine which exercise intensity does a better job at reducing the time spent in a low blood sugar range. The information gained through this study will help individuals with T1D remain active without fear of low blood sugar and provide guidelines for professionals working with this population. Adding high intensity bursts at 80% and 90% of maximum aerobic capacity (active participants) or heart rate reserve (sedentary participants) to a moderate intensity exercise session will significantly reduce the amount of time spent in a low blood sugar range in sedentary and active persons with T1D compared to moderate intensity exercise alone.

NCT ID: NCT03556098 Completed - Clinical trials for Diabetes Mellitus, Type 1

Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes

Start date: February 22, 2019
Phase: N/A
Study type: Interventional

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.

NCT ID: NCT03556033 Completed - Clinical trials for Diabetes Mellitus, Type 1

Effect of Dapagliflozin on IAH in T1DM

Start date: November 23, 2018
Phase: Phase 2
Study type: Interventional

Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired awareness of hypoglycaemia (IAH) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IAH is usually the end-result of a process of habituation to recurrent hypoglycaemia that is potentially reversible. Treatment with sodium glucose cotransporter (SGLT)-2 inhibitors (SGLT-2i) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the SGLT-2 inhibitor, dapagliflozin, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IAH. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 8 weeks with dapagliflozin (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.

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.