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

February 9, 2019 updated by: Dose Safety Inc.

Assessments of Hybrid Closed Loop and Fully Automated Closed Loop Dose Safety Artificial Pancreas Device in Type 1 Diabetes in a Hospital Clinical Research Setting

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

3.1 Overview Two independent questions will be addressed in this study. For evaluation of the safety and efficacy of the hybrid closed loop (HCL), participants will use the hybrid closed loop during and after a standardized meal on the clinical research center. For evaluation of the safety and efficacy of the fully automated closed loop (FACL), participants will use the system for a 24 hour clinical research center stay incorporating meals and standardized exercise. Safety and efficacy will be evaluated by descriptive outcomes including number of completed studies and glycemic control.

3.2 Eligibility. Participants will be recruited from the Diabetes Registry at the Benaroya Research Institute. Eligibile participants may enroll in the HCL, the FACL, or both studies.

HCL Study visit, Day 1 (~7 hours total): The below times are approximate and may be adjusted to accommodate the CRC schedule. Prior to arrival at the CRC, participants will be asked to eat their normal breakfast and take their usual amount of insulin based on BG and carbohydrate content before 8am. Once at the CRC, participants will be able to drink water ad lib, but no food other than the prescribed meals can be eaten, unless hypoglycemia intervention is necessary. Participants will be required to check FSBG before the meal and calibrate if the FSBG value varies by >30% from CGM value.

FACL Study visit, Day 1 (~ 23 hours total): The below times are approximate and may be adjusted to accommodate the CRC schedule. Prior to arrival at the CRC, participants will be asked to eat their normal breakfast and take their usual amount of insulin based on BG and carbohydrate content before 8 am. Once arrived at the CRC, participants will be able to drink water, but no food other than the prescribed meals can be eaten, unless hypoglycemia intervention is necessary. Participants will be required to check FSBG before meals, at bedtime and at 0300. They will calibrate if the FSBG value varies by >30% from the CGM value. They will calibrate the CGM every 12 hours as recommended by Dexcom.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Redmond, Washington, United States, 98052
        • Dose Safety

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pregnant or breast feeding
  • Use of medications other than insulin to control glucose
  • Chronic corticosteroid use
  • Pre-existing medical conditions deemed by study investigator to interfere with the study or increase risks of study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Single Cohort in CRC
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
Device will be used to automatically dose insulin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of time in hypoglycemic range
Time Frame: 36 hours
defined as <70 mg/dL
36 hours
Percentage of time in severe hyperglycemic range
Time Frame: 36 hours
defined as >/=250 mg/dL
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dose Safety Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Benaroya Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APS4
  • 2R44DK104317-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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