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

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®.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Fiasp; Drug: Novolog

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
    • Palo Alto, California, United States, 94305
      • Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Fiasp; Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system; Other Names: Fast Acting Insulin Aspart; Drug: Novolog; Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system; Other Names: Insulin Aspart
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.	Drug: Fiasp; Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system; Other Names: Fast Acting Insulin Aspart; Drug: Novolog; Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system; Other Names: Insulin Aspart

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Medtronic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 23, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): March 30, 2019

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (ACTUAL): June 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: 46202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No