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Mechanisms for Restoration of Hypoglycemia Awareness

Primary Purpose

Type1 Diabetes Mellitus

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Continuous Glucose Monitor (CGM)

Insulin

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
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

Sites / Locations

Yale Center for Clinical Investigation (YCCI) Church Street Research Unit (CSRU)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Aim 3: Type 1 diabetes mellitus user unaware subjects 3 months

Aim 1: Impact of hypoglycemia on brain connectivity Type 1

Aim 2: Impact of hypoglycemia on brain glucose transports in Type 1

Arm Description

Continuous Glucose Monitor for 3 months duration

Healthy controls, T1 aware, and T1 unawares

Outcomes

Primary Outcome Measures

Brain glucose levels

Brain glucose will be lower and brain activation higher in those receiving continuous glucose monitor Rx.

Secondary Outcome Measures

Full Information

NCT ID

NCT03738852

First Posted

November 8, 2018

Last Updated

February 10, 2023

Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT03738852

Brief Title

Mechanisms for Restoration of Hypoglycemia Awareness

Official Title

Mechanisms for Restoration of Hypoglycemia Awareness

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 7, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

blinded

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aim 3: Type 1 diabetes mellitus user unaware subjects 3 months

Arm Type

Experimental

Arm Description

Continuous Glucose Monitor for 3 months duration

Arm Title

Aim 1: Impact of hypoglycemia on brain connectivity Type 1

Arm Type

Experimental

Arm Description

Healthy controls, T1 aware, and T1 unawares

Arm Title

Aim 2: Impact of hypoglycemia on brain glucose transports in Type 1

Arm Type

Experimental

Arm Description

Healthy controls, T1 aware, and T1 unawares

Intervention Type

Device

Intervention Name(s)

Continuous Glucose Monitor (CGM)

Other Intervention Name(s)

Dexcom G6

Intervention Description

Continuous Glucose Monitor (CGM)

Intervention Type

Drug

Intervention Name(s)

Insulin

Intervention Description

standard insulin regimen

Primary Outcome Measure Information:

Title

Brain glucose levels

Description

Brain glucose will be lower and brain activation higher in those receiving continuous glucose monitor Rx.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Janice Hwang, MD

Phone

203-785-6222

janice.hwang@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janice Hwang, Hwang

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale Center for Clinical Investigation (YCCI) Church Street Research Unit (CSRU)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

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Mechanisms for Restoration of Hypoglycemia Awareness

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