The Effects of Finesse on Glycemic Control in Adults With Diabetes Using MDI: Finesse vs. Pen or Syringe and Vial as Bolus Prandial Insulin Device
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Calibra Medical, Inc.
- Enrollment
- 38
- Locations
- 5
- Primary Endpoint
- Mean Daily Blood Glucose
Study Overview
Brief Summary
The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.
Detailed Description
The aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin using their current pen/syringe.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetes mellitus on intensive insulin therapy
Exclusion Criteria
- •Insulin pump therapy
- •Current use of NPH or regular insulin
- •Severe hypoglycemic episodes in prior 6 months
- •Unstable cardiac disease, hepatic, or renal function
Arms & Interventions
Finesse
Finesse Insulin Delivery Patch
Intervention: Finesse (Device)
Usual injection device
Pen/Syringe
Intervention: Pen/Syringe (Usual injection device) (Device)
Outcomes
Primary Outcomes
Mean Daily Blood Glucose
Time Frame: 6 weeks
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
Secondary Outcomes
- Glucose Profiles Per Day(6 weeks)
- Insulin Delivery System Rating(6 weeks)
- Self-reported Hypoglycemic Episodes(6 weeks)