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Insulin

CGM + Insulin for Hypoglycemia Awareness in Type 1 Diabetes

Phase < 1
Waitlist Available
Led By Janice Hwang, Hwang
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy, non-diabetic control or T1DM
Ages > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial assessed whether there are distinct differences in patterns of brain responses to hypoglycemia between type 1 diabetes patients who are aware of hypoglycemia (T1DM-Aware) and those who are unaware of it (T1DM-Unaware), and healthy controls. T1DM-Aware patients showed greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas T1DM-Unaware patients showed no detectable changes in brain reward regions during hypoglycemia.

Who is the study for?
This trial is for adults over 18 with Type 1 Diabetes (T1DM), either aware or unaware of low blood sugar episodes, and healthy individuals as controls. Participants must have a BMI over 18.0 but cannot have severe anemia, untreated thyroid disease, uncontrolled high blood pressure, significant kidney issues, neurological disorders, recent weight fluctuations or steroid use, drug abuse history, diabetes complications like neuropathy or retinopathy, MRI incompatibility issues (like metal implants), current pregnancy/breastfeeding women or those with untreated depression.Check my eligibility
What is being tested?
The study tests how continuous glucose monitoring (CGM) and insulin treatments affect brain responses to low blood sugar in people with T1DM who are either aware or unaware of their hypoglycemia compared to healthy controls. It involves measuring brain activity using fMRI scans during controlled hypoglycemic events.See study design
What are the potential side effects?
Potential side effects from the CGM may include skin irritation at the sensor site. Insulin therapy can cause low blood sugar levels if not managed correctly which might lead to shakiness, sweating, confusion and in severe cases seizures or unconsciousness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy, do not have diabetes, or I have type 1 diabetes.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glucose

Trial Design

3Treatment groups
Experimental Treatment
Group I: Aim 3: Type 1 diabetes mellitus user unaware subjects 3 monthsExperimental Treatment2 Interventions
Continuous Glucose Monitor for 3 months duration
Group II: Aim 2: Impact of hypoglycemia on brain glucose transports in Type 1Experimental Treatment1 Intervention
Healthy controls, T1 aware, and T1 unawares
Group III: Aim 1: Impact of hypoglycemia on brain connectivity Type 1Experimental Treatment1 Intervention
Healthy controls, T1 aware, and T1 unawares
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitor (CGM)
2017
Completed Phase 3
~650
Insulin
2000
Completed Phase 4
~4280

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,146 Total Patients Enrolled
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,628 Total Patients Enrolled
Janice Hwang, HwangPrincipal InvestigatorYale University

Media Library

Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT03738852 — Phase < 1
Type 1 Diabetes Research Study Groups: 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
Type 1 Diabetes Clinical Trial 2023: Insulin Highlights & Side Effects. Trial Name: NCT03738852 — Phase < 1
Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03738852 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently available for this clinical trial?

"The clinical trial is still recruiting participants, according to the details available on clinicaltrials.gov. This medical research was first posted on November 7th 2018 and last updated February 1st 2022."

Answered by AI

What earlier experiments have been conducted regarding Insulin's therapeutic potential?

"Currently, there are 72 active trials studying Insulin with 13 of them in their final phase. Of these studies, many are based out of Cincinnati, Ohio but they span over 248 different sites across the country."

Answered by AI

What is the present pool of participants in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research project is actively seeking subjects to enroll in the trial - first advertised on November 7th 2018 and last updated February 1st 2022. The team is hoping to recruit 54 individuals from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Massachusetts
New York
How old are they?
18 - 65
What site did they apply to?
Yale Center for Clinical Investigation (YCCI) Church Street Research Unit (CSRU)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Mechanisms for Restoration of Hypoglycemia Awareness
2018. "Mechanisms for Restoration of Hypoglycemia Awareness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03738852.
~6 spots leftby Apr 2025
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