- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01073566
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
-
-
California
-
San Francisco, California, United States, 94110
- California Pacific Medical Center
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55416
- International Diabetes Center at Park Nicollet
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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-
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
|
Finesse Insulin Delivery Patch
Other Names:
|
Active Comparator: Usual injection device
Pen/Syringe
|
Pen/Syringe
Other Names:
|
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
Collaborators
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.
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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