Indigo Diabetes enrolls first subject in multi-metabolite sensor trial was published by MedicalDevice-Network.com, 30 September 2022.
Belgian diabetes device company Indigo Diabetes has enrolled the first participant in the Shine (multi-center, open-label, prospective, interventional feasibility study that aims to assess the safety of implantation and preliminary performance of the CMM sensor) clinical trial. The trial’s first participant was enrolled at Antwerp University Hospital (UZA) in Belgium.
The CMM sensor is a small spectrometer-on a-chip designed for monitoring multiple metabolites in-vivo simultaneously and continuously. It is currently being developed to measure ketone, glucose, and lactate levels continuously in diabetes patients. The device works by measuring the absorption of light in the interstitial fluid to simultaneously quantify the concentration of multiple metabolites without using enzymes or fluorophores.
Indigo Diabetes inventor, co-founder, and CEO Danaë Delbeke said: “The start of the Shine trial is an important milestone for Indigo and follows the successful conclusion of the Glow (the first-in-human clinical study of the sensor) trial earlier this year, the results of which we’ve submitted to a peer-reviewed journal for publication. “Many multi-metabolite monitoring devices under development sit on the skin and are highly visible, which some people do not like because they can feel self-conscious, stigmatized, and uncomfortable. Indigo’s continuous multi-metabolite monitor is subcutaneously inserted and is designed to be inconspicuous. We look forward to seeing how it performs in this longer-term stability trial.”
Founded in 2016, the company aims to provide ‘innovative, high-tech solutions for advanced biomarker sensing in diabetes monitoring.
Type 1 Diabetes is More Difficult and Dangerous for Girls was reported by Ross Wollen for DiabetesDaily.com, 3 October 2022.
A major new analysis has found that girls with type 1 diabetes have it much tougher than boys. The work, which reviewed many previous studies with data from tens of thousands of patients, showed that young girls with the condition tend to have poorer metabolic control and experience more diabetic complications. The differences are stunningly comprehensive, and will hopefully spur the development of targeted treatment efforts to erase sex-based inequities.
The study has not yet been published; results were shared in a presentation at the recent European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden.
Multiple studies of type 1 diabetes and life expectancy have found that women experience premature death earlier than men. And a 2015 review referenced in the EASD presentation found that women with T1D had a 40 percent higher risk of all-cause mortality, most notably a nearly doubled risk of fatal cardiovascular disease.
But it wasn’t known if the difference in metabolic health reached all the way back to childhood. Silvia de Vries of Amsterdam University Medical Centers, who presented the study at the conference, partnered with colleagues to find out as they combed through the medical literature, identifying 90 studies with data that could help illuminate the answer.
The results are jaw-dropping:
- Girls with T1D had higher average blood sugar (6.4 mmol/mol, about 0.5 percent on the A1C scale more familiar to Americans), both at diagnosis and later, during treatment.
- Girls were more likely to experience diabetic ketoacidosis (DKA), both during and after diagnosis. DKA incidents were also more severe, on average.
- Girls used more insulin.
- Girls experienced a higher rate of vascular complications, such as nephropathy.
- Most studies showed that girls with T1D had a higher body mass index (BMI) than boys.
- Most studies showed that adolescent girls were more likely to have unhealthy cholesterol levels.
- Girls experienced a higher rate of co-morbidities, including thyroid disease and celiac, two autoimmune disorders common in people with T1D.
- Girls reported a lower quality of life, and greater rates of diabetes distress.
The analysis also showed that boys were more likely to experience hypoglycemia than girls, a likely consequence of their lower overall blood sugars.