Mechanisms for Restoration of Hypoglycemia Awareness

  • End date
    Jun 30, 2024
  • participants needed
  • sponsor
    Yale University
Updated on 21 March 2022
Accepts healthy volunteers


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.


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.

Condition Type1 Diabetes Mellitus
Treatment insulin, Continuous Glucose Monitor (CGM), insulin pump closed loop
Clinical Study IdentifierNCT03738852
SponsorYale University
Last Modified on21 March 2022


Yes No Not Sure

Inclusion Criteria

Ages > 18 years
Healthy, non-diabetic control or T1DM
BMI > 18.0

Exclusion Criteria

Creatinine > 1.5 mg/dL
Hct < 35% for females, < 39% for males
ALT > 2.5 X ULN
untreated thyroid disease
uncontrolled hypertension
neurologic disorders
untreated depression or change in antidepressant regimen in last 3 months
use of any anxiolytic medications (benzodiazepine) or antipsychotic medications
greater than 5% change in weight in last 3 months
current or recent steroid use in last 3 months
illicit drug use
significant complications related to diabetes (peripheral neuropathy, proliferative retinopathy)
inability to enter MRI (per standard MRI safety guidelines)
for women: pregnancy or breastfeeding
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