NCT03428295 is a Phase 1, PHASE2 clinical trial of Dose Safety AP system in Glucose, Low Blood, sponsored by Dose Safety Inc..

Who is sponsoring NCT03428295?

NCT03428295 is sponsored by Dose Safety Inc..

What drugs are being tested in NCT03428295?

Interventions in NCT03428295: Dose Safety AP system.

What condition does NCT03428295 study?

NCT03428295 studies Glucose, Low Blood, Glucose, High Blood.

Is NCT03428295 still recruiting?

NCT03428295 is currently suspended. Last updated 12 February 2019.

Last reviewed 2019-02-12 · How we verify

NCT03428295

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

Dose Safety Hybrid Closed Loop and Fully Automated Closed Loop Artificial Pancreas Device in CRC

Suspended Phase 1, PHASE2 Last updated 12 February 2019

What this trial tests

Phase 1, PHASE2 trial testing Dose Safety AP system in Glucose, Low Blood in 20 participants. Suspended.

Timeline

22 June 2017

Primary endpoint
31 August 2019

31 August 2019

Quick facts

Lead sponsor	Dose Safety Inc.
Phase	Phase 1, PHASE2
Status	Suspended
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	22 June 2017
Primary completion	31 August 2019
Estimated completion	31 August 2019
Sites	1 location across United States

Drugs / interventions tested

Dose Safety AP system

Conditions studied

Glucose, Low Blood — all drugs for Glucose, Low Blood →
Glucose, High Blood — all drugs for Glucose, High Blood →

Sponsor

Dose Safety Inc.

Who can join

Adults 18 to 70, any sex, with Glucose, Low Blood or Glucose, High Blood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to test two different operating modes of the latest version of the Dose Safety artificial pancreas system (APS), the Dose Safety Controller (DSC version 2.3), in a population of subjects with type 1 diabetes (TID) in a hospital CRC setting. The first mode is the Fully Automated Closed Loop (FACL) mode, in which all insulin delivery is directed by the controller and the second mode is the Hybrid Closed Loop (HCL) mode, in which insulin delivery is a hybrid between controller directed delivery and user directed insulin delivery. There will be two study arms: HCL and FACL. No comparisons will be made between the two arms.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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 NCT03428295 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dose Safety Inc.
Last refreshed: 12 February 2019

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/NCT03428295.

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