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Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy | Clinical Trials | Clareo Health

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Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy

Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy: To Assess How the 670G System Adapts to the Introduction of Fiasp® Insulin

NCT03554486•Stanford University

View on ClinicalTrials.gov

Summary

This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.

Detailed Description

This will be a randomized cross-over blinded study and to see how the 670G pump responds to the introduction of Fiasp® insulin. Subjects enrolled in the study will have a 2 week period of optimization with weekly assessments of their Carelink download before entering the blinded phase of the study. They will use their usual home insulin during the optimization phase. They will then be started on their first blinded insulin (aspart or Fiasp®) which they will use for 2 weeks, before they cross-over to the other insulin.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Clinical diagnosis of type 1 diabetes and using 670G pump for at least 1 month, and willing to have the 670G pump downloaded into a Carelink Clinical research database.
•2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
•3. Age ≥18 years
•4. Using Novolog or Fiasp® insulin at time of enrollment
•5. Willing to use Fiasp® insulin
•6. Total daily insulin dose is at least 0.3 units/kg/day
•7. Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast
•8. For females, not currently known to be pregnant
•9. An understanding of and willingness to follow the protocol and sign the informed consent
•10. Willing to have photographs taken of their infusion sites
+5 more criteria

Exclusion Criteria

•1. Pregnant or lactating females
•2. No hypoglycemic seizure or loss of consciousness in the past 6 months
•3. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
•4. No known cardiovascular events in the last 6 months
•5. No active proliferative diabetic retinopathy
•6. Known tape allergies
•7. Current treatment for a seizure disorder
•8. Cystic fibrosis
•9. Active infection
•10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
+7 more criteria

Locations (2)

Stanford University

Palo Alto, California, United States

Stanford

Palo Alto, California, United States

Key Dates

Start Date

July 23, 2018

Primary Completion Date

March 30, 2019

Completion Date

March 30, 2019

Last Updated

August 18, 2021

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1

Interventions

Fiasp

DRUG

Novolog

DRUG

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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: August 18, 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 Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy

Inclusion Criteria

Exclusion Criteria

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