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

Overview

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®.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 30, 2019

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.

Interventions

  • Drug: Fiasp
    • Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system
  • Drug: Novolog
    • Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system

Arms, Groups and Cohorts

  • Experimental: Fiasp then Novolog
    • Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.
  • Experimental: Novolog then Fiasp
    • Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
    • Time Frame: 7 days (during 2nd half of 2-week intervention period)
    • Measured as percentage of time in range (days).
  • Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
    • Time Frame: 7 days (during 2nd half of 2-week intervention period)
    • Percentage of time in range (days) as a measure of hypoglycemia.

Secondary Measures

  • Mean Sensor Glucose in mg/dl
    • Time Frame: 7 days (during 2nd half of 2-week intervention period)
    • Mean sensor data over the second week of using a randomized, blinded insulin.

Participating in This Clinical Trial

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 11. Willing to download their 670G pump every 1-2 weeks to a research Carelink account 12. Willingness to answer a brief online questionnaire every 2 weeks 13. Must be able to understand spoken or written English 14. For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care 15. Hemoglobin A1c between 6 and 10% at the time of enrollment 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 11. Inpatient psychiatric treatment in the past 6 months 12. Presence of a known adrenal disorder 13. 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 14. Abuse of alcohol 15. Dialysis or renal failure 16. Known eGFR <60% Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Collaborator
    • Medtronic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bruce Buckingham, Professor of Pediatric Endocrinology – Stanford University
  • Overall Official(s)
    • Bruce Buckingham, MD, Principal Investigator, Stanford University

References

Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.

Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.

Hsu L, Buckingham B, Basina M, Ekhlaspour L, von Eyben R, Wang J, Lal RA. Fast-Acting Insulin Aspart Use with the MiniMedTM 670G System. Diabetes Technol Ther. 2021 Jan;23(1):1-7. doi: 10.1089/dia.2020.0083.

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