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

March 13, 2012 updated by: Calibra Medical, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • California Pacific Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center at Park Nicollet
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Finesse
Finesse Insulin Delivery Patch
Device: Finesse
Finesse Insulin Delivery Patch
Other Names:
  • Insulin Bolus Patch
Active Comparator: Usual injection device
Pen/Syringe
Device: Pen/Syringe (Usual injection device)
Pen/Syringe
Other Names:
  • Insulin pen
  • Insulin syringe
  • Insulin injection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Daily Blood Glucose
Time Frame: 6 weeks
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Profiles Per Day
Time Frame: 6 weeks
Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days
6 weeks
Insulin Delivery System Rating
Time Frame: 6 weeks
Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.
6 weeks
Self-reported Hypoglycemic Episodes
Time Frame: 6 weeks
Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calibra Medical, Inc.

Collaborators

Northwestern University
University of Texas Southwestern Medical Center
Henry Ford Health System
International Diabetes Center at Park Nicollet
Nancy Bohannon, MD, Med. Corp.

Investigators

  • Study Director: Vice President Clinical Affairs, Calibra Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

April 9, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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