CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 55 enrolled
Drug / intervention
Insulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03738852
NCT03738852Early Ph 1Completed
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Mechanisms for Restoration of Hypoglycemia Awareness

Yale University·interventional·Posted Nov 13, 2018·Updated Feb 12, 2025

In Brief

A Early Phase 1 clinical trial evaluating Continuous Glucose Monitor (CGM) and Insulin for Type1 Diabetes Mellitus. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedNov 13, 2018
Enrollment StartNov 7, 2018
Primary CompletionAug 14, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.6 years ago

Interventions

Continuous Glucose Monitor (CGM)device

Continuous Glucose Monitor (CGM)

Insulindrug

standard insulin regimen