The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus (PLATEAU)
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring continuous glucose monitoring, continuous subcutaneous insulin infusion, hyperglycemia, correction bolus
Eligibility Criteria
Inclusion Criteria:
- Male and female patients > 18 years of age
- Type 1 DM of > 1 year duration
- Use of any open loop insulin pump, Tandem T-Slim with Basal IQ, Insulet Omnipod Dash, or any other investigator-approved insulin pumps with Dexcom CGM G5, G6, or newer version for > 6 months
- Good baseline glycemic control (HbA1c < 7.5%; low risk of hypoglycemia by CGM as defined by Dexcom Clarity report)
- No episodes of severe hypoglycemia in the previous 3 months
- Pump download shows regular meal bolusing, accurate carbohydrate counting ability, and willingness to use exercise markers in Dexcom
- CGM download shows regular use (>85% of time) and regular calibration if using G5 sensor (G6 requires no calibration)
- Females using adequate contraception
Exclusion Criteria:
- Use of CGM other than Dexcom G5 or G6 or a newer Dexcom CGM version
- Suboptimal baseline glycemic control (HbA1c > 7.5%)
- Pump or CGM download shows suboptimal use of devices (lack of meal boluses, frequent overrides of pump, excessive pump suspension, inadequate calibration or inconsistent usage of CGM)
- Serious comorbidities including CVD with recent event, actively treated malignancy, renal dysfunction with eGFR < 45 ml/min, or any other condition which in the opinion of the investigator would preclude subject's ability to participate in trial
- Females unwilling to use contraception, planning pregnancy or breastfeeding
- Use of any other glucose-lowering agents than insulin
- Hypersensitivity to insulin aspart or one of the excipients in faster insulin aspart
- Known diabetic gastroparesis
Sites / Locations
- Mountain Diabetes and Endocrine CenterRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
No Intervention: Conventional Insulin Aspart (NovoLog®)
Faster Insulin Aspart (Fiasp®)
In the aspart group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Aspart is put into their pump and delivered to their body through a small tube placed under your skin. In this NovoLog®-only treatment group, the subject will take aspart with each meal while your pump also gives you a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study.
In the Fiasp group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Fiasp is put into their pump and delivered to their body through a small tube placed under their skin. In this Fiasp treatment group, the subject will take fiasp with each meal while their pump also gives them a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study.