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Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy | Clinical Trials | Clareo Health

WITHDRAWNNA

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

NCT04284033•Stanford University

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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
+5 more criteria

Locations (1)

Stanford University

Palo Alto, California, United States

Key Dates

Start Date

February 14, 2017

Primary Completion Date

November 10, 2017

Completion Date

April 20, 2018

Last Updated

September 2, 2021

Conditions

Type 1 Diabetes

Interventions

Extended Wear Infusion Set

DEVICE

Standard Infusion Set

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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