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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Finesse
* Device: Pen/Syringe (Usual injection device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Finesse<br>Finesse Insulin Delivery Patch | Device: Finesse<br>* Finesse Insulin Delivery Patch<br>* Other names: Insulin Bolus Patch;|
| Active Comparator: Usual injection device<br>Pen/Syringe | Device: Pen/Syringe (Usual injection device)<br>* Pen/Syringe<br>* Other names: Insulin injection device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daily Blood Glucose | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune System Diseases, Autoimmune Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Insulin, Metabolic Diseases