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

NCT03428295 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Glucose, Low Blood
  • Glucose, High Blood

Interventions

DEVICE

Dose Safety AP system

Device will be used to automatically dose insulin

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Benaroya Research Institute

    collaborator OTHER

  • Dose Safety Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-08-31
Completion
2019-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428295 on ClinicalTrials.gov