NCT03353415 is a NA clinical trial of Dexcom CGM masked in Hypoglycemia, Reactive, sponsored by Joslin Diabetes Center.

Who is sponsoring NCT03353415?

NCT03353415 is sponsored by Joslin Diabetes Center.

What drugs are being tested in NCT03353415?

Interventions in NCT03353415: Dexcom CGM masked, Dexcom CGM unmasked.

What condition does NCT03353415 study?

NCT03353415 studies Hypoglycemia, Reactive, Hypoglycemia.

Is NCT03353415 still recruiting?

NCT03353415 is currently completed. Last updated 28 August 2023.

Are results published for NCT03353415?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-08-28 · How we verify

NCT03353415

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery

Completed NA Results posted Last updated 28 August 2023

What this trial tests

NA trial testing Dexcom CGM masked in Hypoglycemia, Reactive in 26 participants. Completed in 12 April 2023.

Timeline

7 February 2019

Primary endpoint
11 November 2021

12 April 2023

Quick facts

Lead sponsor	Joslin Diabetes Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	7 February 2019
Primary completion	11 November 2021
Estimated completion	12 April 2023
Sites	1 location across United States

Drugs / interventions tested

Dexcom CGM masked
Dexcom CGM unmasked

Conditions studied

Hypoglycemia, Reactive — all drugs for Hypoglycemia, Reactive →
Hypoglycemia — all drugs for Hypoglycemia →

Sponsor

Joslin Diabetes Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Hypoglycemia, Reactive or Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase. Primary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<70 mg/dl, comparing the masked versus the unmasked phases.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	4.7	± 4.8
Unmasked CGM Wear (Phase 2)	2.9	± 2.5

Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase Primary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<60 mg/dl, comparing the masked versus the unmasked phases.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	1.4	± 1.7
Unmasked CGM Wear (Phase 2)	0.7	± 0.8

Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase Primary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<60 mg/dl, comparing the masked versus the unmasked phases.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	0.6	± 0.8
Unmasked CGM Wear (Phase 2)	0.2	± 0.3

Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	97.5	87.0 – 113.5
Unmasked CGM Wear (Phase 2)	97.0	87.0 – 113.0

Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	103.8	± 12.3
Unmasked CGM Wear (Phase 2)	104.1	± 7.4

Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

expressed as median and median standard deviation

Group	Value	95% CI
Masked CGM Wear (Phase 1)	263.0	± 51.9
Unmasked CGM Wear (Phase 2)	256.0	± 42.3

Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

The sensor glucose level range is derived from the difference between the highest sensor glucose levels minus the lowest sensor glucose level (mg/dL).

Group	Value	95% CI
Masked CGM Wear (Phase 1)	221.5	± 52.6
Unmasked CGM Wear (Phase 2)	209.5	± 50.4

Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	40.0	± 0.0
Unmasked CGM Wear (Phase 2)	42.0	± 3.0

Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	90.8	± 5.2
Unmasked CGM Wear (Phase 2)	94.8	± 3.9

Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	3.1	± 2.8
Unmasked CGM Wear (Phase 2)	1.7	± 1.6

Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	0.1	± 0.2
Unmasked CGM Wear (Phase 2)	0.1	± 0.1

Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase Secondary · 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Group	Value	95% CI
Masked CGM Wear (Phase 1)	29.8	± 7.1
Unmasked CGM Wear (Phase 2)	26.6	± 5.2

Adverse events — posted to ClinicalTrials.gov

Time frame: For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 28 days. For participants using a Dexcom G4 sensor, adverse event data were collected over a period of 20 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Masked CGM Wear (Phase 1)

Serious: 1/25 (4%)

Deaths: 0/25

Unmasked CGM Wear (Phase 2)

Serious: 0/23 (0%)

Deaths: 0/23

Serious adverse events (1 terms)

Reaction	System	Masked CGM Wear (Phase 1)	Unmasked CGM Wear (Phase 2)
Depressive episode	General disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Masked CGM Wear (Phase 1)	Unmasked CGM Wear (Phase 2)
Skin irritation under Dexcom G4 sensor site	Skin and subcutaneous tissue disorders	—	—
Hypoglycemia requiring emergency department evaluation	Metabolism and nutrition disorders	—	—
Mild erythema under dexcom G4 sensor adhesive	Skin and subcutaneous tissue disorders	—	—
Discomfort at site of Dexcom G4 sensor	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Depressive episode.

Data from ClinicalTrials.gov NCT03353415 adverse events section.

Sponsor's own description

The purpose of this study is to see if the use of a continuous glucose monitor (CGM) by people who experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number and severity of low blood sugar episodes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Cognition in patients with post-bariatric hypoglycemia.
Puleio A, Sheehan A, Musen G, Patti ME. · · 2024 · cited 3× · PMID 37667837 · DOI 10.1002/oby.23862

Verify or expand the search:

Other recruiting trials for Hypoglycemia, Reactive

Currently open trials in the same condition.

NCT06986603 — Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia · Phase 4 · active not recruiting

Other Joslin Diabetes Center trials

Trials by the same sponsor.

NCT07271043 — Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incre · NA · recruiting
NCT07467694 — Postnatal Exercise to Activate Baby's Brown Fat · NA · recruiting
NCT06511310 — Exercise, Brain Activity, and Weight Maintenance · NA · recruiting
NCT07082478 — External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia · recruiting
NCT07468188 — Diabetes Body Project 2 · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03353415 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Joslin Diabetes Center
Last refreshed: 28 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03353415.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing