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

Trial ID or NCT#

NCT03554486

Status

not recruiting iconNOT RECRUITING

Purpose

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®.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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 years4. Using Novolog or Fiasp® insulin at time of enrollment5. Willing to use Fiasp® insulin6. Total daily insulin dose is at least 0.3 units/kg/day7. Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast8. For females, not currently known to be pregnant9. An understanding of and willingness to follow the protocol and sign the informed consent10. Willing to have photographs taken of their infusion sites11. Willing to download their 670G pump every 1-2 weeks to a research Carelink account12. Willingness to answer a brief online questionnaire every 2 weeks13. Must be able to understand spoken or written English14. For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care15. Hemoglobin A1c between 6 and 10% at the time of enrollment
Exclusion Criteria:
  1. 1. Pregnant or lactating females2. No hypoglycemic seizure or loss of consciousness in the past 6 months3. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure4. No known cardiovascular events in the last 6 months5. No active proliferative diabetic retinopathy6. Known tape allergies7. Current treatment for a seizure disorder8. Cystic fibrosis9. Active infection10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol11. Inpatient psychiatric treatment in the past 6 months12. Presence of a known adrenal disorder13. 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 study14. Abuse of alcohol15. Dialysis or renal failure16. Known eGFR \<60%
    1. Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
View All Criteria
Show Less

Investigator(s)

Bruce Buckingham
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
Marina Basina
Marina Basina
Endocrinologist
Clinical Professor, Medicine - Endocrinology, Gerontology, & Metabolism

View on ClinicalTrials.gov