Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections

Calibra Medical

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Device: Finesse; Device: Pen/Syringe (Usual injection device)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01073566

VP-00007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Finesse

Experimental group

Description:

Finesse Insulin Delivery Patch

Treatment:

Device: Finesse

Usual injection device

Active Comparator group

Description:

Pen/Syringe

Treatment:

Device: Pen/Syringe (Usual injection device)