Also known as: low blood sugar, severe hypoglycemia
Rezolute's Phase 3 sunRIZE trial for ersodetug failed to meet primary and key secondary endpoints in congenital hyperinsulinism. Shares collapsed about 85-90% on December 11, 2025, and a securities law firm is investigating potential claims.
The FDA approved Tzield for stage 3 type 1 diabetes, and the therapy was given to children in Canada for the first time. Research also advanced on engineered islets and stem-cell treatments.
Nationwide FDA recalls include generic Adderall XR (mix-up), levothyroxine (subpotent), Gas-X (coolant contamination), and several prescription drugs classed as Class II. Moringa dietary supplements are under Class I recall due to serious health risks. Consumers are advised to check lot numbers and consult pharmacists.
Sequel Med Tech reported positive pivotal trial results for its twiist Automated Insulin Delivery System in adults with type 2 diabetes. The 13-week study showed meaningful improvements in HbA1c and time in range with no severe hypoglycemia events. Separately, Sequel and Senseonics launched the twiist system integrated with Eversense 365 CGM across the U.S.
FDA approves MannKind's Afrezza inhaled insulin for children aged 6+ with type 1 and type 2 diabetes. Separately, an updated label provides new starting dose guidance for adults switching from injections or insulin pumps.
A case report details a 63-year-old woman with insulin autoimmune syndrome and Hashimoto thyroiditis, presenting with hypoglycemia as low as 27 mg/dL. Elevated insulin and autoantibody titers confirmed the diagnosis. Prednisolone therapy rapidly improved glycemic stability, and the patient remained euglycemic after tapering.
GLP-1 drugs used for type 2 diabetes and obesity are seeing rising demand for weight loss as safety concerns also draw attention. A 2025 WHO guideline said long-term safety data remains limited.
C-peptide is described as a key biomarker for beta cell function in type 1 diabetes and a potential surrogate endpoint for drug approval. Current trial endpoints remain difficult for disease-modifying therapies.
A multicenter retrospective cohort study of 17 patients with type 2 diabetes and end-stage renal disease found injectable semaglutide was associated with descriptive changes in glycemic control and body weight. No cardiovascular deaths, nonfatal myocardial infarctions, or nonfatal strokes were observed during follow-up.
The congenital hyperinsulinism pipeline includes 4+ active companies and 4+ therapies across clinical and nonclinical stages. Zealand Pharma advanced dasiglucagon in January 2026, while RZ358 is in Phase III evaluation.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07696910 |
Perioperative Hypoglycemia in Diabetic Patients Undergoing Vitrectomy: a Masked CGM Prospective Observational Study |
NOT_YET_RECRUITING | |
| NCT07614139 |
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders |
COMPLETED | NA |
| NCT07375615 |
Continous Glucose Monitoring in Neonates at Risk of Hypoglycaemia- a Feasibility Study |
COMPLETED | |
| NCT07329985 |
FEAR of HYPOGLYCEMIA in PATIENTS WITH DIABETES |
NOT_YET_RECRUITING | |
| NCT07286500 |
"Sexual Activity and Hypoglycemia Risk in Adults With Type 1 or Type 2 Diabetes Using Insulin Therapy and Continuous Glucose Monitoring" |
RECRUITING | |
| NCT07233421 |
Frequency of Hypoglycemia in Children With Beta-blocker Treated Long QT-syndrome |
ENROLLING_BY_INVITATION | NA |
| NCT07132476 |
The Construction and Validation of a Risk Prediction Model for Perioperative Hypoglycemia in Digestive Endoscopy |
COMPLETED | |
| NCT07082478 |
External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia |
RECRUITING | |
| NCT06986603 |
Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia |
ACTIVE_NOT_RECRUITING | PHASE4 |
| NCT06893341 |
Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events |
RECRUITING | NA |
