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NCT03840278 · ClinicalTrials.gov registry record · Phase 2

The Bihormonal iLet Bionic Pancreas Feasibility Study

A Phase 2 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 2
Development phase
12
Enrollment target

NCT03840278: Completed Phase 2 study, sponsored by Massachusetts General Hospital.

NCT03840278 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03840278, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target

Study Summary

Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.

Primary Outcome

Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.

Interventions

  • DRUG Dasiglucagon
  • DEVICE Bihormonal iLet Bionic Pancreas
  • DEVICE Insulin-only Bionic Pancreas

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2019-05-15
Est. Completion 2019-07-03
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

What the finished NCT03840278 record still lists

NCT03840278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 3 interventions - of which Dasiglucagon is the first listed.

NCT03840278 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03840278 about?

NCT03840278 is a clinical study titled "The Bihormonal iLet Bionic Pancreas Feasibility Study". Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.

What is the current status of trial NCT03840278?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2019-05-15. Estimated completion is 2019-07-03.

What interventions are being tested in trial NCT03840278?

The interventions under investigation include: Dasiglucagon (DRUG), Bihormonal iLet Bionic Pancreas (DEVICE), Insulin-only Bionic Pancreas (DEVICE).

Who is sponsoring clinical trial NCT03840278?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03840278's enrollment target sits among peer trials

12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03840278, the US trial registry maintained by the National Library of Medicine. NCT03840278 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.