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Phase COVID-NA

Mechanisms for restoration of hypoglycemia awareness

  • Study HIC#:2000023189
  • Last Updated:07/15/2021

Determine the impact of frequent hypoglycemia and hypoglycemia unawareness on brain responses to visual food cues as well as brain functional connectivity in T1DM patients. Aim 2: Assess the impact of antecedent bouts of hypoglycemia on brain glucose transport/metabolism during hyperglycemia in T1DM Unaware, T1DM Aware as well as healthy controls using 1H, 13C magnetic resonance spectroscopy (MRS). Aim 3: Determine if reducing hypoglycemia and glycemic variability using closed loop insulin delivery reverses altered brain glucose transport/metabolism and functional connectivity in hypoglycemia unaware T1DM patients.

  • Start Date11/07/2018
  • End Date04/30/2023

Trial Purpose and Description

Aim 1: Determine the impact of frequent hypoglycemia and hypoglycemia unawareness on brain responses to visual food cues as well as brain functional connectivity in T1DM patients. 

Aim 2: Assess the impact of antecedent bouts of hypoglycemia on brain glucose transport/metabolism during hyperglycemia in T1DM Unaware, T1DM Aware as well as healthy controls using 1H, 13C magnetic resonance spectroscopy (MRS).

Aim 3: Determine if reducing hypoglycemia and glycemic variability using closed loop insulin delivery reverses altered brain glucose transport/metabolism and functional connectivity in hypoglycemia unaware T1DM patients. 

Eligibility Criteria

Inclusion Criteria:

 Ages > 18 years

Healthy, non-diabetic control or T1DM (with HbA1C < 8%)

BMI > 18.0

Exclusion Criteria:

 Creatinine > 1.5 mg/dL

 Hgb < 10 mg/dL

 ALT > 2.5 X ULN

 untreated thyroid disease

 uncontrolled hypertension

 neurologic disorders

psychiatric disorders

 use of psychiatric medication

 greater than 5% change in weight in last 3 months

 malignancy

smoking

current or recent steroid use in last 3 months

Principal Investigator

Sub-Investigators

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