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

This study has been completed.
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.
ClinicalTrials.gov Identifier:
NCT01073566
First received: February 22, 2010
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Calibra Medical, Inc.:

Primary Outcome Measures:
  • Mean Daily Blood Glucose [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose


Secondary Outcome Measures:
  • Glucose Profiles Per Day [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days

  • Insulin Delivery System Rating [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Self-reported Hypoglycemic Episodes [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 38
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073566

Locations
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
Study Director: Vice President Clinical Affairs Calibra Medical, Inc.
  More Information

Publications:
Responsible Party: Calibra Medical, Inc.
ClinicalTrials.gov Identifier: NCT01073566     History of Changes
Other Study ID Numbers: VP-00007
Study First Received: February 22, 2010
Results First Received: February 9, 2012
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

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:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014