NCT03738852

Mechanisms for Restoration of Hypoglycemia Awareness

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.

Detailed description

To assess the following: 1) if these differences are driven purely by recurrent hypoglycemia or by other closely linked factors (e.g. glycemic variability); 2) the molecular and metabolic mechanisms by which unawareness leads to the suppression of central nervous system (CNS) activity in the context of hypoglycemia; and 3) whether hypoglycemia avoidance using continuous glucose monitor restores central nervous system (CNS) activation and metabolism toward normal levels and offers a therapeutic approach to more effectively combat neurocognitive dysfunction associated with intensive treatment of T1DM patients.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor (CGM)	Continuous Glucose Monitor (CGM)
DRUG	Insulin	standard insulin regimen

Timeline

• Start date: 2018-11-07
• Primary completion: 2023-08-14
• Completion: 2023-08-14
• First posted: 2018-11-13
• Last updated: 2025-02-12
• Results posted: 2025-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study