The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this investigator-initiated trial is to compare the efficacy in terms of time to recovery from hyperglycemia as measured by time to arrest of hyperglycemic excursion ("glucose plateau point", primary endpoint) and return to premeal glucose target if feasible (secondary endpoint) between Fiasp and conventional insulin aspart when used as a correction bolus. These endpoints will be determined by CGM (Dexcom) from data exported from the Dexcom Clarity program.

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

Details

• Lead Sponsor: Mountain Diabetes and Endocrine Center
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

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