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

• Sponsor: Stanford University
• Collaborator: Medtronic
• Information provided by (Responsible Party): Bruce A. Buckingham, Stanford University

Study Description

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®.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1	Drug: Fiasp; Drug: Novolog	Phase 4

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Intervention Model Description:	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.
Masking:	Double (Participant, Investigator)
Masking Description:	Double-blinded
Primary Purpose:	Treatment
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
Actual Study Start Date :	July 23, 2018
Estimated Primary Completion Date :	November 2018
Estimated Study Completion Date :	May 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1; Group 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 Name: Fast Acting Insulin Aspart; Drug: Novolog; Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system; Other Name: Insulin Aspart
Experimental: Group 2; Group 2 will use Novolog insulin for 2 weeks, followed by Fiasp 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 Name: Fast Acting Insulin Aspart; Drug: Novolog; Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system; Other Name: Insulin Aspart

Outcome Measures

Primary Outcome Measures :

1. Percent of sensor glucose values between 70-180 mg/dl [ Time Frame: Seven Days - Last week of values for each arm of the study ]
   Measure of time in range
2. Percent of sensor glucose readings <70 mg/dl [ Time Frame: Seven Days - Last week of values for each arm of the study ]
   Measure of hypoglycemia

Secondary Outcome Measures :

1. Mean sensor glucose in mg/dl [ Time Frame: Seven days - last week of values for each arm of the study ]
   Mean sensor glucose

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Locations

Layout table for location information

United States, California
Stanford University	Recruiting
Palo Alto, California, United States, 94304
Contact: Liana Hsu, BS 650-725-3939 rkingman@stanford.edu
Contact: Ryan Kingman, BS 650-736-4417 rkingman@stanford.edu
Principal Investigator: Bruce Buckingham, MD
Sub-Investigator: Marina Basina, MD
Sub-Investigator: Rayhan Lal, MD

Sponsors and Collaborators

Stanford University

Medtronic

More Information

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.

Layout table for additonal information

Responsible Party:	Bruce A. Buckingham, Professor of Pediatric Endocrinology, Stanford University
ClinicalTrials.gov Identifier:	NCT03554486 History of Changes
Other Study ID Numbers:	46202
First Posted:	June 13, 2018
Last Update Posted:	August 24, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Layout table for MeSH terms

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases	Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Hypoglycemic Agents; Physiological Effects of Drugs