Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Known eGFR <60%
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Sites / Locations
- Stanford University
- Stanford
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Fiasp then Novolog
Novolog then Fiasp
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.
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.