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

Withdrawn before enrolling · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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

Key facts

Study ID

NCT04284033

Run by

Stanford University

People needed

0

Starts

2017-02-14

Expected to finish

2018-04-20

Last updated by the study team

2021-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Age ≥18 years
• Using Novolog or Humalog insulin at time of enrollment
• For females, not currently known to be pregnant
• An understanding of and willingness to follow the protocol and sign the informed consent
• Willing to have photographs taken of their infusion sites
• Willing to download their 670G pump every week to a research Carelink account
• Willing to submit a brief online questionnaire at the time of any infusion set failure
• Able to understand spoken or written English
• Hemoglobin A1c <8.5% at the time of enrollment
• Willing to perform three or more fingerstick glucose measurements each day
• Willing to sign a consent for release of medical information at the time of enrollment
• Willing to change their infusion pump insulin reservoirs at least every 6 days

You may not qualify if…

• Hypoglycemic seizure or loss of consciousness in the past 6 months
• Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
• A known cardiovascular disease
• Active proliferative diabetic retinopathy
• Known tape allergy
• Current treatment for a seizure disorder
• Cystic fibrosis
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
• Inpatient psychiatric treatment in the past 6 months
• Presence of a known adrenal disorder
• 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
• Abuse of alcohol
• History of dialysis, renal failure or known eGFR <60 ml/min/1.73m2
• Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment

Where it is running

• Stanford University — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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