Early Phase 1 N=33 Randomized Single-blind Treatment

Mechanisms for Restoration of Hypoglycemia Awareness

Type1 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT03738852 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Brain Glucose Levels — 2.45; 2.16 Mmol/L — p=0.907

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Continuous Glucose Monitor (CGM) (Device); Insulin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Brain Glucose Levels	2.45; 2.16	0.907

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Creatinine > 1.5 mg/dL
Hct 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
malignancy
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03738852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.