Clinical trials: Severe Hypoglycemia
Hypoglycemia
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
- Trial name
- NCT01972152
- Testing
- G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg, G-Pen(TM) 0.5 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Xeris Pharmaceuticals
Hypoglycemia, Type 1 Diabetes
EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes
The aim of this study is based on recent pilot studies carried out at Odense University Hospital showing that the acute changes in electroencephalographic (EEG) signals (i.e.
- Trial name
- NCT00810420
- Where
- Denmark
- Sponsor
- UNEEG Medical A/S
Hypoglycemia Unawareness, Diabetes Mellitus, Type 1
Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo.
- Trial name
- NCT03490942
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 49 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes Mellitus, Type 1
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use…
- Trial name
- RECORD-IQ (NCT07211126)
- Testing
- t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
- Where
- 25 sites in France
- Volunteers
- 350 people
- Sponsor
- Tandem Diabetes Care, Inc.
Diabetes Mellitus Type 1
A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose.
- Trial name
- SUGR (NCT06651515)
- Testing
- Allogeneic Pancreatic Endocrine Cell Clusters
- Where
- 2 sites in United States
- Sponsor
- Seraxis
Critical Illness, Energy Supply; Deficiency, Severe
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU)
The survival and the outcomes of critically ill patients are strongly influenced by insulin-therapy and nutritional support. The GLUCOSAFE 2 pilot study, aims to test the performance and the security of the new GLUCOSAFE 2…
- Conditions
- Critical Illness, Energy Supply; Deficiency, Severe, Protein Deficiency, Hypoglycemia
- Trial name
- NCT03890432
- Testing
- GLUCOSAFE 2, Local protocol control group with routine care, Historical control group with routine care
- Where
- 2 sites in Switzerland
- Volunteers
- 213 people
- Sponsor
- HEIDEGGER CP
Hypoglycemia, Type 1 Diabetes
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use.
- Trial name
- NCT05378672
- Testing
- Dasiglucagon
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Zealand Pharma
Type 1 Diabetes, Severe Hypoglycemic Unawareness
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control.
- Trial name
- NCT01897688
- Testing
- Islet Cell Transplant
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Northwestern University
Type 1 Diabetes
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years.
- Trial name
- RescuiNGkids (NCT04992312)
- Testing
- Glucagon Nasal Powder [Baqsimi]
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company
Pregnancy, Diabetes
Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes
Background: The risk of stillbirth and preterm delivery is three times increased among pregnant women with type 1 diabetes compared with healthy pregnant women.
- Trial name
- NCT00435565
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Diabete Mellitus, Diabete Type 1
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose.
- Trial name
- NCT07581197
- Testing
- Allogeneic pancreatic endocrine cell clusters
- Volunteers
- 9 people
- Sponsor
- Seraxis
Type 1 Diabetes
Insulin Analogues and Severe Hypoglycaemia
Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated.
- Trial name
- NCT00346996
- Testing
- insulin levemir / aspart, human insulin /insulin isophane
- Where
- Denmark
- Volunteers
- 179 people
- Sponsor
- Lise Tarnow
Obesity, Hypoglycemia
Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia
With increasing rates of obesity the number of anti-obesity operations performed is increasing; one of the most common is gastric bypass.
- Conditions
- Obesity, Hypoglycemia, Surgery
- Trial name
- NCT01865760
- Testing
- Oral Glucose tolerance test (OGGT), Liquid mixed meal, Octreotide
- Where
- Denmark
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Central Line-Associated Bloodstream Infection (CLABSI), Venous Thromboembolism
Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable…
- Conditions
- Central Line-Associated Bloodstream Infection (CLABSI), Venous Thromboembolism, Patient Fall, Catheter-Associated Infection
- Trial name
- PSLL (NCT02969343)
- Testing
- Patient Safety health information technology
- Where
- United States
- Volunteers
- 21,000 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Insulin Hypoglycemia, Type 1 Diabetes Mellitus
G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus.
- Conditions
- Insulin Hypoglycemia, Type 1 Diabetes Mellitus, Severe Hypoglycemia
- Trial name
- NCT03439072
- Testing
- G-Pen, Lilly Glucagon
- Where
- 6 sites in United States, Canada
- Volunteers
- 81 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes (DM), Diabete Mellitus
Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups
Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes.
- Conditions
- Diabetes (DM), Diabete Mellitus, Diabete Type 1, Diabete Type 2
- Trial name
- TwinPeaks (NCT07212075)
- Where
- 3 sites in Germany
- Volunteers
- 1,809 people
- Sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1
Baby Detect : Genomic Newborn Screening
Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions.
- Conditions
- Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1, Phosphoglucomutase 1 Deficiency, Maturity Onset Diabetes of the Young
- Trial name
- BabyDetect (NCT05687474)
- Where
- Belgium
- Volunteers
- 6,824 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Liege
Type 1 Diabetes
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
- Trial name
- MIP310 (NCT00211536)
- Testing
- Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Medtronic MiniMed Implantable Pump System, Aventis HOE21PH U400
- Where
- 5 sites in United States
- Volunteers
- 107 people
- Sponsor
- Medtronic MiniMed, Inc.
Insulin Hypoglycemia, Type 1 Diabetes Mellitus
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus.
- Conditions
- Insulin Hypoglycemia, Type 1 Diabetes Mellitus, Severe Hypoglycemia
- Trial name
- NCT03738865
- Testing
- G-Pen, Novo Glucagon
- Where
- 7 sites in United States, Austria and 1 more
- Volunteers
- 132 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes Mellitus, Type 1, Hypoglycemia
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the…
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia, Islet Cell Transplantation, Type 1 Diabetes
- Trial name
- NCT06575426
- Testing
- OPF-310
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Factory, Inc.