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

NCT03554486 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 46202
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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®.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Mean Sensor Glucose in mg/dl

  7 days (during 2nd half of 2-week intervention period)

Study Arms (2)

Fiasp then Novolog

EXPERIMENTAL

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; Drug: Novolog

Novolog then Fiasp

EXPERIMENTAL

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; Drug: Novolog

Interventions

Fiasp DRUG

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

Also known as: Fast Acting Insulin Aspart

Fiasp then Novolog; Novolog then Fiasp

Novolog DRUG

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

Also known as: Insulin Aspart

Fiasp then Novolog; Novolog then Fiasp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stanford University: lead
• Medtronic: collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94304, United States

Location

Stanford

Palo Alto, California, 94305, United States

Location

Related Publications (3)

• 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.

  PMID: 28918652 BACKGROUND

• 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.

  PMID: 28055230 BACKGROUND

• 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.

  PMID: 32520594 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Bruce Buckingham
• Organization: Stanford

buckingham@stanford.edu

6508040476

Study Officials

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Endocrinology

Model Details: Subjects will be randomly assigned to start with either Fiasp insulin or Novolog insulin. After 2 weeks, they will start the previously unassigned insulin and continue using it for another 2 weeks.

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 13, 2018
• Study Start: July 23, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: August 18, 2021
• Results First Posted: August 18, 2021

Record last verified: 2021-08

Locations

US (2)