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Continuous Glucose Monitor

Masked CGM Wear (Phase 1) for 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

No Placebo-Only Group

Summary

This trial tests if a continuous glucose monitor (CGM) can help people who have low blood sugar after gastric surgery. The CGM tracks blood sugar levels all day and night, alerting users to low levels so they can take action. This could reduce the number and severity of low blood sugar episodes. Continuous glucose monitoring (CGM) has become widely available and has been shown to improve blood sugar control in patients with diabetes.

Eligible Conditions

Hypoglycemia
Reactive Hypoglycemia
Low Blood Sugar

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days for those participants wearing dexcom g4, and 20 days for participants wearing dexcom g6.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase

Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear

Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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