Clinical Research Directory

Umbilical Cord Glucose

Congenital hyperinsulinism (HI) causes persistent neonatal hypoglycemia that, if untreated, can lead to neurodevelopmental impairments (NDI) such as cognitive delays, cerebral palsy, epilepsy, and blindness. Despite being preventable with early diagnosis and treatment, 30-50% of affected infants still suffer NDI. Transient HI occurs in about 1 in 1,200 births, while persistent forms are rarer. Current screening focuses on high-risk groups but misses many infants with HI, resulting in delayed diagnosis and brain injury. Our pilot research suggests that measuring umbilical cord blood glucose (UCBG), already routinely collected for other purposes, can serve as a timely, non-invasive screening test for HI. Arterial UCBG below 3.5 mmol/L showed excellent accuracy in predicting pathological HI. This project aims to validate UCBG screening for neonatal HI, implement a national screening program, and assess the neurological outcomes of screen-positive infants. Planned studies: 1. A review will analyze current screening strategies and the impact of delayed diagnosis on brain outcomes 2. A nationwide, prospective study in Denmark will implement UCBG screening in all newborns. Infants with arterial UCBG below 3.5 mmol/L will undergo hypoglycemia monitoring and diagnostic testing. Diagnostic accuracy and optimal thresholds will be evaluated. 3. Neurological follow-up at 6 months will assess development using standardized cognitive and motor tests, EEG, and MRI. 4. A retrospective observational study to investigate whether UCBG can provide improved risk stratification for hypoglycaemia in infants born to mothers with diabetes.

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 disorders (IMDs), such as glycogen storage disorders (GSDs) and congenital hyperinsulinism (CH). The main questions it aims to answer are: Does a CGM with predictive alerts lower the time spent with low blood sugar compared to a CGM with standard alerts? Do participants feel better and behave differently when using a CGM with predictive alerts? How accurate are the two CGM devices in this group of people? Researchers will compare two CGM devices - Dexcom G7 (with predictive and standard alerts) and Dexcom ONE+ (with standard alerts only) - to see if predictive alerts help reduce low blood sugar episodes and improve quality of life. Participants will: Wear each CGM device for 30 days Have a 30-day break between the two devices Check blood sugar levels and record food intake Complete questionnaires about their experience with each device