Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy

August 29, 2021 updated by: Bruce Buckingham, Stanford University
This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes

Study Overview

Status

Status

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Withdrawn

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

This study will compare use of a standard infusion set with an extended wear infusion set. Subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. The order of infusion set wear will be randomized with the first set wear. The investigators aim to see whether there is a benefit to using an extended wear infusion set.

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

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
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes for more than one year, using an insulin infusion pump for at least 6 months, and using the 670G pump for at least 3 months
  2. Age ≥18 years
  3. Using Novolog or Humalog insulin at time of enrollment
  4. For females, not currently known to be pregnant
  5. An understanding of and willingness to follow the protocol and sign the informed consent
  6. Willing to have photographs taken of their infusion sites
  7. Willing to download their 670G pump every week to a research Carelink account
  8. Willing to submit a brief online questionnaire at the time of any infusion set failure
  9. Able to understand spoken or written English
  10. Hemoglobin A1c <8.5% at the time of enrollment
  11. Willing to perform three or more fingerstick glucose measurements each day
  12. Willing to sign a consent for release of medical information at the time of enrollment
  13. Willing to change their infusion pump insulin reservoirs at least every 6 days

Exclusion Criteria:

  1. Hypoglycemic seizure or loss of consciousness in the past 6 months
  2. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
  3. A known cardiovascular disease
  4. Active proliferative diabetic retinopathy
  5. Known tape allergy
  6. Current treatment for a seizure disorder
  7. Cystic fibrosis
  8. Active infection
  9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
  10. Inpatient psychiatric treatment in the past 6 months
  11. Presence of a known adrenal disorder
  12. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the last 2 months prior to enrollment in the study
  13. Abuse of alcohol
  14. History of dialysis, renal failure or known eGFR <60 ml/min/1.73m2
  15. Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment

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: Crossover 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: Standard then Extended Infusion Set
Participants will start with wearing the standard infusion set for up to 7 days, then switch to the Extended Wear infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks
Device: Extended Wear Infusion Set
For two of the 4 weeks, the Extended Wear insulin infusion set will be used
Device: Standard Infusion Set
For two of the 4 weeks, the standard insulin infusion set will be used
Experimental: Extended then Standard Infusion Set
Participants will start with wearing the Extended Wear infusion set for up to 7 days, then switch to the standard infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks
Device: Extended Wear Infusion Set
For two of the 4 weeks, the Extended Wear insulin infusion set will be used
Device: Standard Infusion Set
For two of the 4 weeks, the standard insulin infusion set will be used

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
Number of infusion set failures due to "unexplained hyperglycemia"
Time Frame: 14 days for each type of infusion set, with each type of infusion set worn twice

Defined as:

  1. Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL
  2. Ketones ≥0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness)
  3. Evidence of infection at the infusion site (erythema or induration >1cm in diameter)
  4. Pump occlusion alarm
14 days for each type of infusion set, with each type of infusion set worn twice

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
Duration of infusion set wear
Time Frame: 14 days for each type of infusion set, with each type of infusion set worn twice
The maximum number of days that 75% of the infusion sets are still working, excluding those that kinked on insertion or were accidentally pulled out.
14 days for each type of infusion set, with each type of infusion set worn twice

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.
Stanford University

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.
Medtronic

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.
February 14, 2017

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.
November 10, 2017

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.
April 20, 2018

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 22, 2020

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 22, 2020

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 25, 2020

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.
September 2, 2021

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.
August 29, 2021

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.
August 1, 2021

More Information

Terms related to this study

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.
  • 52526

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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