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

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 1

In brief

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®.

Key facts

Study ID

NCT03554486

Run by

Stanford University

People needed

27

Starts

2018-07-23

Expected to finish

2019-03-30

Last updated by the study team

2021-08-18

Who can join

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

You may qualify if…

• 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.
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
• Age ≥18 years
• Using Novolog or Fiasp® insulin at time of enrollment
• Willing to use Fiasp® insulin
• Total daily insulin dose is at least 0.3 units/kg/day
• Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast
• 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 1-2 weeks to a research Carelink account
• Willingness to answer a brief online questionnaire every 2 weeks
• Must be able to understand spoken or written English
• For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care
• Hemoglobin A1c between 6 and 10% at the time of enrollment

You may not qualify if…

• Pregnant or lactating females
• No 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
• No known cardiovascular events in the last 6 months
• No active proliferative diabetic retinopathy
• Known tape allergies
• 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, with lack of stability on the medication for the past 2 months prior to enrollment in the study
• Abuse of alcohol
• Dialysis or renal failure
• Known eGFR <60%
• Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.

Where it is running

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

Full record on ClinicalTrials.gov

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