Clinical trials: Hypoglycemic Syndrome
Diabetes, Hypoglycemia
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients
A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to fasting-induced hypoglycemia in healthy adults.
- Trial name
- GLEAM (NCT04430660)
- Testing
- 13C-MRS procedure/Acetate infusion, Continuous glucose monitoring
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pennington Biomedical Research Center
Pregnancy Preterm, Neonatal Hypoglycemia
Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study
Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late…
- Conditions
- Pregnancy Preterm, Neonatal Hypoglycemia, Hyperglycemia Drug Induced
- Trial name
- E-ALPS (NCT03076775)
- Testing
- Maternal glycemic control
- Where
- 2 sites in United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Post-bariatric Surgery
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the…
- Trial name
- GLP-1 (NCT01803451)
- Testing
- exendin-(9-39), exendin -(9-39)
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
Hypoglycemia
PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to…
- Trial name
- NCT02081001
- Testing
- Novo Nordisk GlucaGen®, G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Xeris Pharmaceuticals
Type 1 Diabetes, Hypoglycemia
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1…
- Trial name
- NCT05076292
- Testing
- GlucaGen, Saline
- Where
- Denmark
- Volunteers
- 22 people
- Sponsor
- Steno Diabetes Center Copenhagen
Respiratory Distress, Hypoglycemia
Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year
Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term).
- Conditions
- Respiratory Distress, Hypoglycemia, Feeding Intolerance, Jaundice
- Trial name
- NCT00550069
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sheba Medical Center
Type 2 Diabetes
Freestyle Libre and Hospital Admissions in Type 2 Diabetes
This study aims to investigate the utility of a combination of structured nurse led intervention and the use of Freestyle libre in adults with type 2 diabetes who have suffered an episode of severe hypoglycaemia in terms of…
- Trial name
- STRATUS (NCT04997512)
- Testing
- Freestyle libre, Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- University of Leeds
Diabetes Mellitus, Type 2, Arrhythmia, Cardiac
Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes
Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along with a control group of twenty-one…
- Trial name
- HYPO-HEART (NCT03150030)
- Testing
- Combined hyper- and hypoglycaemic clamp, Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA), Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)
- Where
- Denmark
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital, Gentofte, Copenhagen
Brittle Type 1 Diabetes Mellitus
Safety, Tolerability, and Efficacy of Immunomodulation With AT-1501 in Combination With Transplanted Islet Cells in Adults With Brittle T1D
This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant.
- Trial name
- NCT05480657
- Testing
- AT-1501 IV Infusion, Isolated cadaveric islet cells
- Where
- United States
- Sponsor
- Eledon Pharmaceuticals
Type 1 Diabetes Mellitus, Hypoglycemia
Hypoglycaemia Awareness Restoration Programme
Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death.
- Trial name
- HARPdoc (NCT02940873)
- Testing
- HARPdoc courses, BGAT courses
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 99 people
- Sponsor
- King's College London
Hypoglycemia
Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia
The purpose of this study is to compare the accuracies and the capillary and venous comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart in an adult…
- Trial name
- NCT01013402
- Testing
- Human insulin
- Where
- Turkey (Türkiye)
- Volunteers
- 51 people
- Sponsor
- Gulhane School of Medicine
Diabetes Mellitus, Type 1
Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM
We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients with type 1 diabetes when compared to type 1 diabetic…
- Trial name
- NCT00515801
- Testing
- glibenclamide
- Where
- Switzerland
- Volunteers
- 18 people
- Sponsor
- University Hospital, Basel, Switzerland
Type 1 Diabetes, Diabetes Mellitus
Therapeutic Education in Very Young Children With Diabetes Mellitus
DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management…
- Trial name
- DIAB-EDUC (NCT01354288)
- Testing
- Educational tool
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes Mellitus, Type 1
Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study
This study aims to compare the effect of flash glucose monitoring (FGM) with traditional self-monitoring of blood glucose (SMBG) with or without carbohydrate counting and automated bolus calculation, in patients with type 1…
- Trial name
- NCT03682237
- Testing
- Carbohydrate counting, automated bolus calculation, Flash glucose monitoring (FGM)
- Where
- Denmark
- Volunteers
- 184 people
- Sponsor
- Steno Diabetes Center Copenhagen
Congenital Hyperinsulinism
GLP-1 Receptor Expression in CHI
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.
- Trial name
- GLP-1-CHI (NCT03768518)
- Testing
- 68Ga-exendin-4 PET/CT
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Type 2 Diabetes Mellitus
GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Investigation of GIP effects at fasting and hypoglycemia
- Trial name
- GIP-HYPO-T2DM (NCT01414556)
- Testing
- Glucose-dependent Insulinotropic polypeptide, saline
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Mikkel Christensen
Glycogen Storage Disease, Congenital Hyperinsulinism (CHI)
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
The goal of this clinical trial is to learn if a continuous glucose monitor (CGM) with predictive alerts works better than a CGM with standard alerts to prevent low blood sugar (hypoglycemia) in adults with inherited metabolic…
- Conditions
- Glycogen Storage Disease, Congenital Hyperinsulinism (CHI), Hypoglycemia
- Trial name
- NCT07614139
- Testing
- Continuous glucose monitor with threshold and predictive alerts (Dexcom G7), Continuous glucose monitor with threshold-only alerts (Dexcom ONE+)
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- University Hospital Padova
Hypoglycemia, Obesity
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia.
- Trial name
- NCT00998374
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Type 1 Diabetes Mellitus
Safety and Feasibility Evaluation of the APS APP
This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the…
- Trial name
- NCT03504046
- Testing
- Artificial Pancreas App
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sansum Diabetes Research Institute