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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01073566
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : April 9, 2012
Last Update Posted : April 9, 2012
Sponsor:
Collaborators:
Nancy Bohannon, MD, Med. Corp.
Henry Ford Health System
Northwestern University
University of Texas Southwestern Medical Center
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
Calibra Medical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Finesse Device: Pen/Syringe (Usual injection device) Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Finesse
Finesse Insulin Delivery Patch
 Device: Finesse
Finesse Insulin Delivery Patch
Other Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Daily Blood Glucose [ Time Frame: 6 weeks ]
    Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073566


Locations
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United States, California
California Pacific Medical Center
San Francisco, California, United States, 94110
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
International Diabetes Center at Park Nicollet
Minneapolis, Minnesota, United States, 55416
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Calibra Medical, Inc.
Nancy Bohannon, MD, Med. Corp.
Henry Ford Health System
Northwestern University
University of Texas Southwestern Medical Center
International Diabetes Center at Park Nicollet
Investigators
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Study Director: Vice President Clinical Affairs Calibra Medical, Inc.
More Information
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Publications of Results:

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Responsible Party: Calibra Medical, Inc.
ClinicalTrials.gov Identifier: NCT01073566    
Other Study ID Numbers: VP-00007
First Posted: February 23, 2010    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: April 9, 2012
Last Verified: March 2012
Keywords provided by Calibra Medical, Inc.:
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
 Immune System Diseases
Insulin
Metabolic Diseases
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs