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

• Status: Completed
• Trial end date: 2019-03-30
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Medtronic
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

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.