NCT03977727

FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump

An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Texas Diabetes & Endocrinology, P.A. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.

Detailed description

This study is being performed to compare Fiasp® in terms of glycemic control with a focus on post-prandial 1-hour plasma glucose level and system-based outcomes to NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period. Subjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period. After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Fiasp®	Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
DRUG	Novolog®	Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
DEVICE	670G hybrid closed loop continuous subcutaneous insulin infusion system	CSII

Timeline

• Start date: 2019-06-11
• Primary completion: 2020-03-09
• Completion: 2020-04-20
• First posted: 2019-06-06
• Last updated: 2020-09-29
• Results posted: 2020-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study