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| Name | Class |
|---|---|
| Nancy Bohannon, MD, Med. Corp. | UNKNOWN |
| Henry Ford Health System | OTHER |
| Northwestern University | OTHER |
| University of Texas Southwestern Medical Center |
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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.
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 (Finesseâ„¢; 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finesse | Experimental | Finesse Insulin Delivery Patch |
|
| Usual injection device | Active Comparator | Pen/Syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finesse | Device | Finesse Insulin Delivery Patch |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Blood Glucose | Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose | 6 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vice President Clinical Affairs | Calibra Medical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94110 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21732797 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Finesse Then Usual Injection Device | Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks |
| FG001 | Usual Injection Device Then Finesse | Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (6 Weeks) |
| |||||||||||||
| Period 2 (6 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Finesse Then Usual Injection Device | Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks |
| BG001 | Usual Injection Device Then Finesse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Daily Blood Glucose | Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose | Intent to treat | Posted | Least Squares Mean | Standard Error | mmol/L | 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Finesse | Bolus Patch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis eosinophilic | Gastrointestinal disorders |
The short duration of the study precludes comments on longer-term outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical Affairs | Calibra Medical | 650-298-4750 | ddreon@calibra.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D001327 | Autoimmune Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D007154 | Immune System Diseases |
| D007333 | Insulin Resistance |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
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| OTHER |
| International Diabetes Center at Park Nicollet | OTHER |
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| Pen/Syringe (Usual injection device) | Device | Pen/Syringe |
|
|
| 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| International Diabetes Center at Park Nicollet | Minneapolis | Minnesota | 55416 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| NOT COMPLETED |
|
|
Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Glucose Profiles Per Day | Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days | Intent to Treat | Posted | Least Squares Mean | Standard Error | mmol/L | 6 weeks |
|
|
|
|
| Secondary | 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. | Per Protocol | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Secondary | 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. | Intent to treat | Posted | Number | episodes | 6 weeks |
|
|
|
| 1 |
| 38 |
| 8 |
| 38 |
| EG001 | Usual Injection Device | Pen/Syringe | 1 | 38 | 9 | 38 |
| Acute Pancreatitis | Gastrointestinal disorders |
|
| Tooth ache | Gastrointestinal disorders |
|
| Tooth disorder | Gastrointestinal disorders |
|
| Medical device site reaction | General disorders |
|
| Acute pyelonephritis | Infections and infestations |
|
| Flu | Infections and infestations |
|
| Pharyngitis | Infections and infestations |
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| Upper respiratory infection | Infections and infestations |
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| Urinary tract infection | Infections and infestations |
|
| Knee pain | Musculoskeletal and connective tissue disorders |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Postnasal drip | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders |
|
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