Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Fiasp; Novolog
Intervention description: Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system; Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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®.
    

Eligibility 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.