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

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Finesse; Device: Pen/Syringe (Usual injection device)

• Registration Number: NCT01073566
• Lead Sponsor: Calibra Medical, Inc.

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2012-02-09
• Results First Submitted QC: 2012-03-13
• Results First Posted: 2012-04-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Finesse	Finesse	Finesse Insulin Delivery Patch
Usual injection device	Pen/Syringe (Usual injection device)	Pen/Syringe

Primary Outcome Measures

Name	Time	Method
Mean Daily Blood Glucose	6 weeks	Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose

Secondary Outcome Measures

Name	Time	Method
Glucose Profiles Per Day	6 weeks	Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days
Insulin Delivery System Rating	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.
Self-reported Hypoglycemic Episodes	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.

Trial Locations

Locations (5)

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

International Diabetes Center at Park Nicollet; 🇺🇸 Minneapolis, Minnesota, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States