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Continuous Glucose Monitor

Masked CGM Wear (Phase 1) for Reactive Hypoglycemia

N/A
Waitlist Available
Led By Mary Elizabeth Patti, MD
Research Sponsored by Joslin Diabetes Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days for those participants wearing dexcom g4, and 20 days for participants wearing dexcom g6.
Awards & highlights

Study Summary

This trial will test if a continuous glucose monitor can help reduce low blood sugar episodes for people who have gastric surgery.

Eligible Conditions
  • Reactive Hypoglycemia
  • Low Blood Sugar

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days for those participants wearing dexcom g4, and 20 days for participants wearing dexcom g6.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for those participants wearing dexcom g4, and 20 days for participants wearing dexcom g6. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase
Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase
Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase.
Secondary outcome measures
1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Unmasked CGM Wear (Phase 2)Experimental Treatment1 Intervention
In the second phase, participants will be able to read the sensor glucose levels (unmasked). Frequency of hypoglycemia will be compared between the two phases of the study.
Group II: Masked CGM Wear (Phase 1)Experimental Treatment1 Intervention
Each participant will wear the Dexcom CGM for two sequential phases. During the first phase, participants will not be able to read the sensor glucose levels (masked).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexcom CGM masked
2019
N/A
~30
Dexcom CGM unmasked
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Joslin Diabetes CenterLead Sponsor
96 Previous Clinical Trials
26,547 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,824 Total Patients Enrolled
Mary Elizabeth Patti, MDPrincipal InvestigatorJoslin Diabetes Center
4 Previous Clinical Trials
258 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
South Carolina
Tennessee
Other
Arizona
How old are they?
18 - 65
What site did they apply to?
Joslin Diabetes Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
1

Why did patients apply to this trial?

To control my reactive hypoglycaemia.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Joslin Diabetes Center: < 48 hours
Recent research and studies
The Lancet Diabetes & EndocrinologyJournal
The Rollercoaster of Post-bariatric Hypoglycaemia
Patti, Mary-Elizabeth, and Allison B Goldfine. 2016. “The Rollercoaster of Post-bariatric Hypoglycaemia”. The Lancet Diabetes & Endocrinology. Elsevier BV. doi:10.1016/s2213-8587(15)00460-x.
clinicaltrials.govStudy
Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery
2019. "Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03353415.
~4 spots leftby Apr 2025
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