NCT03428295

Brief 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

February 5, 2018

Last Update Submit

February 9, 2019

Conditions

Glucose, Low BloodGlucose, High Blood

Keywords

artificial pancreasautomated insulin deliveryhybrid closed loopAPDSfully automated closed loop

Outcome Measures

Primary Outcomes (2)

  • Percentage of time in hypoglycemic range

    defined as \<70 mg/dL

    36 hours

  • Percentage of time in severe hyperglycemic range

    defined as \>/=250 mg/dL

    36 hours

Study Arms (1)

Experimental: Single Cohort in CRC

EXPERIMENTAL

This study is a single-arm, single-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting.

Device: Dose Safety AP system

Interventions

Dose Safety AP systemDEVICE

Device will be used to automatically dose insulin

Experimental: Single Cohort in CRC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have type 1 diabetes for greater than 1 year
  • Have a hemoglobin A1c less than 9.0%
  • Participants in the FACL arm must report that they engage in aerobic exercise at least 30 minutes three times weekly
  • If participants in the FACL arm are age \>35 OR duration of T1D \>15 years OR history of T1D complications (proliferative retinopathy, nephropathy, peripheral vascular disease, autonomic neuropathy), participant must have EKG within normal limits obtained within last 6 months of study date
  • Age 18-70
  • Fluent and literate in English
  • Use of an insulin pump for ≥ 3 months
  • Use of a CGM/sensor for ≥ 5 days/week for ≥3 months
  • Must have a diabetes care provider
  • Use of an effective birth control method for women who are sexually active and of childbearing potential
  • Willing and able to give informed consent

You may not qualify if:

  • History of ≥ 1 episode of severe hypoglycemia (defined as hypoglycemia leading to loss of consciousness, seizure, or requiring assistance) in the previous 6 months
  • History of ≥ 1 episode of DKA in the previous 6 months
  • History of cardiovascular disease, characterized by any of the following:
  • Prolonged QT or arrhythmia
  • History of myocardial infarction within the past 6 months
  • History of ischemia on functional cardiac exam within the last year
  • History of left ventricular ejection fraction \< 30%
  • Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg)
  • Current use of a beta blocker
  • Stage 3 or greater renal disease
  • Untreated thyroid disease
  • History of substance abuse
  • Current or previous use of medications for control of a seizure disorder
  • Enrolled in another clinical trial in which they received investigational drug in the last 12 weeks
  • Inability to comply with protocol
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dose Safety

Redmond, Washington, 98052, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Experimental: Single Cohort in CRC This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. Intervention: Device: Dose Safety Artificial Pancreas (AP) System
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 9, 2018

Study Start

June 22, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)