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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Finesse

Finesse Insulin Delivery Patch

Group Type EXPERIMENTAL

Finesse

Intervention Type DEVICE

Finesse Insulin Delivery Patch

Usual injection device

Pen/Syringe

Group Type ACTIVE_COMPARATOR

Pen/Syringe (Usual injection device)

Intervention Type DEVICE

Pen/Syringe

Interventions

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Finesse

Finesse Insulin Delivery Patch

Intervention Type DEVICE

Pen/Syringe (Usual injection device)

Pen/Syringe

Intervention Type DEVICE

Other Intervention Names

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Insulin Bolus Patch Insulin pen Insulin syringe Insulin injection device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No