Clinical trial NCT01073566: Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Insulin
Metabolic Diseases
Lead sponsor: Calibra Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nancy Bohannon, MD, Med. Corp.
name: Henry Ford Health System
name: Northwestern University
name: University of Texas Southwestern Medical Center
name: International Diabetes Center at Park Nicollet
First posted: 2010-02-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Mean Daily Blood Glucose
timeFrame: 6 weeks
Secondary outcomes:
measure: Glucose Profiles Per Day
timeFrame: 6 weeks
measure: Insulin Delivery System Rating
timeFrame: 6 weeks
measure: Self-reported Hypoglycemic Episodes
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center at Park Nicollet
state: Minnesota
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Calibra Medical, Inc.
name: Vice President Clinical Affairs
role: STUDY_DIRECTOR
References:
citation: Bohannon N, Bergenstal R, Cuddihy R, Kruger D, List S, Massaro E, Molitch M, Raskin P, Remtema H, Strowig S, Whitehouse F, Brunelle RL, Dreon D, Tan M. Comparison of a novel insulin bolus-patch with pen/syringe injection to deliver mealtime insulin for efficacy, preference, and quality of life in adults with diabetes: a randomized, crossover, multicenter study. Diabetes Technol Ther. 2011 Oct;13(10):1031-7. doi: 10.1089/dia.2011.0047. Epub 2011 Jul 6.