Status:
UNKNOWN
The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus
Lead Sponsor:
Mountain Diabetes and Endocrine Center
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 p...
Detailed Description
Patients with type 1 DM using CSII require bolus insulin for two purposes: first, to cover carbohydrate intake to control postprandial glucose, and second, to correct episodes of hyperglycemia. The la...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04414579
Start Date
March 27 2019
End Date
March 1 2021
Last Update
November 24 2020
Active Locations (1)
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1
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803