Clinical trials: Severe Hypoglycemia, open to volunteers
T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus
An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events
This study is an open-label, single-arm, non-randomized trial designed to evaluate the safety and preliminary efficacy of CRG-002 administered via portal vein infusion or transplantation beneath the anterior rectus sheath in…
- Trial name
- NCT07503028
- Testing
- CRG002
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Celregen Therapeutics
Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia
Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
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
- Trial name
- Pilot'Ex (NCT05221359)
- Testing
- ExOlin®, Insulin aspart
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Defymed
Severe Hypoglycemia, Type1diabetes
Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes
The GLUREDIA study investigates the counter-regulatory response (CRR) during hypoglycemia in children with type 1 diabetes (T1D).
- Trial name
- GLUREDIA (NCT06770621)
- Testing
- Insulin-induced hypoglycemia test, Glucagon profile, Biological sample once
- Where
- Belgium
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
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.
Obesity (Disorder)
Continuous Glucose Monitoring in Metabolic Surgery
We will recruit 20 severely obese participants at Metamor Institute. Participants with obesity who are eligible for MBS will be randomized to either CGM group or self-monitoring of blood glucose (SMBG) group before the surgery…
- Trial name
- NCT07095972
- Testing
- Abbot Freestyle Libre CGM
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Pennington Biomedical Research Center
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
- Conditions
- Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
- Trial name
- NCT04786262
- Testing
- VX-880, VX-017
- Where
- 29 sites in United States, Canada and 8 more
- Volunteers
- 57 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness
A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia
- Conditions
- Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
- Trial name
- NCT07126873
- Testing
- Allogeneic Human E-islet (E-islet 01)
- Where
- China
- Volunteers
- 21 people
- Sponsor
- EndoCell Therapeutics, Inc.
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
The goal of this observational study is to better understand how the amount of insulin people with type 1 diabetes are using relates to blood glucose control and the risk of complications.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD), Severe Albuminuria, Estimated Glomerular Filtration Rate (eGFR)
- Trial name
- iDose-EDC (NCT07911033)
- Testing
- Routine/prescribed exogenous insulin dose
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Rachel Miller
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 (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