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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554486
• Other study ID #: 46202
• Status: Completed
• Phase: Phase 4
• Start date: July 23, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: August 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
United States	Stanford	Palo Alto	California
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)