Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

June 22, 2017 updated by: Mark DeBoer, MD, University of Virginia
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.

Study Overview

Status

Status

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

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

Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies. Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues. During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery. However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use). These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings. It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents. In this sense, young children require a device that is not user-centered as much as family-centered. A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.

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 (Actual)

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.
12

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.
  • Not Applicable

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
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Center for Diabetes Technology

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

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes,

    • The diagnosis of type 1 diabetes is based on the investigator's judgment
    • C peptide levels and antibody determinations are not required
  • Daily insulin therapy for ≥ 12 months
  • Insulin pump therapy for ≥ 3 months
  • Age ≥5 - ≤8 years old
  • Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
  • Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

  • Diabetic ketoacidosis in the past month
  • Hypoglycemic seizure or loss of consciousness in the past 3 months
  • History of seizure disorder (except for hypoglycemic seizure)
  • History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  • Cystic fibrosis
  • Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
  • History of ongoing renal disease (other than microalbuminuria).
  • Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
  • Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
  • Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.

  • Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:

    • Inpatient psychiatric treatment in the past 6 months
    • Uncontrolled adrenal insufficiency

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: Randomized
  • Interventional Model: Parallel 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: Group A
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
Device: Diabetes Assistant (DiAs) with Closed-Loop
All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
Experimental: Group B
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
Device: Diabetes Assistant (DiAs) with Closed-Loop
All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

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
Percent of Sensor Glucose Readings Between 70-180 mg/dL
Time Frame: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Time Frame: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >150 mg/dL
Time Frame: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Percent of Time Sensor Glucose Readings Are >180 mg/dL
Time Frame: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >250 mg/dL
Time Frame: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >400 mg/dL
Time Frame: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Time Frame: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Maximum)
Time Frame: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Minimum)
Time Frame: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Time Frame: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Mean BG (as Measured by CGM)
Time Frame: 68 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Hypoglycemia Area Under the Curve <60
Time Frame: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Hypoglycemia Area Under the Curve <70 mg/dL
Time Frame: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Hyperglycemia Area Under the Curve >180
Time Frame: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Hyperglycemia Area Under the Curve >250 mg/dL
Time Frame: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Time Frame: 68 hours
All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
68 hours
End of Night Blood Glucose
Time Frame: 72 hours
All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
72 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.
University of Virginia

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.
DexCom, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

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.
May 1, 2016

Primary Completion (Actual)

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.
May 1, 2016

Study Completion (Actual)

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.
May 1, 2016

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).
April 15, 2016

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.
April 20, 2016

First Posted (Estimate)

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.
April 25, 2016

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.
July 24, 2017

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.
June 22, 2017

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.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 18888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Not yet determined

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