Grant: Project Grant

In healthy individuals, blood sugar levels are tightly controlled by 2 hormones: insulin & glucagon. Secretion of insulin, a vital hormone to reduce blood sugar, is lost in type 1 diabetes (T1D). Thus, patients with T1D are treated by intensive insulin therapy using multiple daily injections or continuous insulin infusion pump. Hypoglycemia (low blood sugar) is frequent in T1D individuals. In case of hypoglycemia, patients might need glucagon, a key hormone to raise blood glucose. Hypoglycemia remains underestimated, with up to 80% of events unrecognized. Recurrent hypoglycemia leading to hypoglycemia unawareness (HU; lost ability to detect early signs of hypoglycemia) can be observed in approximately 40% of patients. These patients are exposed to a 6-fold increased risk of severe hypoglycemia (requiring assistance) and more than 10% of patients have at least 1 episode/year. These patients urgently need new therapeutic strategies. We have developed a wearable external artificial pancreas (WEAP) that regulates sugar levels for adults with T1D. Two configurations of the WEAP have been developed, one that infuses insulin & another that infuses insulin & glucagon. The WEAP with glucagon further reduces the risk of hypoglycemia. The systems are composed of three components: continuous glucose sensor (to read blood sugar changes), infusion pumps (to provide insulin with or without glucagon) & an intelligent dosing method that links the sensor with the pump (to suggest dose changes to the pump based on glucose values). In order to show the effectiveness of the 2 systems in T1D patients with HU, we aim to compare the two WEAP systems in a 3-week study. We will also assess if the WEAP can reverse HU. The WEAP has a great potential to improve patients' quality of life, improve health outcomes & reduce the burden of diabetes management for the patients and their healthcare providers. Patients with HU should largely benefit from the WEAP.