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Hypoglycemia clinical trials

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NCT ID: NCT02685852 Completed - Clinical trials for Hyperinsulinemic Hypoglycemia

Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

Start date: February 2016
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.

NCT ID: NCT02666521 Completed - Clinical trials for Diabetes Mellitus, Type 2

Hypoglycaemia in People With Type 2 Diabetes in Primary Care

Start date: July 20, 2012
Phase:
Study type: Observational

Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care. The aim of this study is to provide robust data on the frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore associated risk factors.

NCT ID: NCT02665715 Completed - Clinical trials for Bariatric Surgery (Gastric Bypass)

Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?

Start date: August 2015
Phase: N/A
Study type: Interventional

Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. The pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive hypoglycemia prevented.

NCT ID: NCT02660242 Completed - Clinical trials for Diabetes Mellitus, Type 1

The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

Start date: January 2016
Phase: Phase 2
Study type: Interventional

This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.

NCT ID: NCT02660008 Completed - Hypoglycemia Clinical Trials

Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon

Start date: January 2016
Phase: Phase 2
Study type: Interventional

The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as compared to marketed glucagon.

NCT ID: NCT02657213 Completed - Diabetes, Type 1 Clinical Trials

Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

ALPPHY
Start date: February 2016
Phase: N/A
Study type: Interventional

The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia. The study should show: - A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline. - A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation

NCT ID: NCT02657083 Completed - Clinical trials for Type 1 Diabetes Mellitus

Prevention of Hypoglycemia After Exercise Using Closed Loop System in Children and Adolescents With Type 1 Diabetes

PHYSI-DREAM
Start date: January 2016
Phase: N/A
Study type: Interventional

The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the standard treatment without computer algorithm decisions - SAP therapy in 20 children and adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity. The aims of the study are: - to demonstrate that the use of DreaMed MD-AID is safe during physical activity - to investigate the risk of hypoglycemia among children and adolescents with T1D after afternoon exercise during closed-loop control.

NCT ID: NCT02656069 Completed - Clinical trials for Diabetes Mellitus, Type 1

Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics

Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for hypoglycemia rescue of adult patients with type 1 diabetes.

NCT ID: NCT02631265 Completed - Type 1 Diabetes Clinical Trials

Insulin-based Strategies to Prevent Hypoglycemia During Exercise

Start date: January 2016
Phase: N/A
Study type: Interventional

It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.

NCT ID: NCT02605369 Completed - Preterm Birth Clinical Trials

SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.