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

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ClinicalTrials.gov Identifier: NCT01073566
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : April 9, 2012
Last Update Posted : April 9, 2012
Sponsor:
Collaborators:
Nancy Bohannon, MD, Med. Corp.
Henry Ford Health System
Northwestern University
University of Texas Southwestern Medical Center
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
Calibra Medical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus
Interventions Device: Finesse
Device: Pen/Syringe (Usual injection device)
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Finesse Then Usual Injection Device Usual Injection Device Then Finesse
Hide Arm/Group Description 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 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
Period Title: Period 1 (6 Weeks)
Started 19 19
Completed 19 19
Not Completed 0 0
Period Title: Period 2 (6 Weeks)
Started 19 19
Completed 18 19
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Finesse Then Usual Injection Device Usual Injection Device Then Finesse Total
Hide Arm/Group Description 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 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 Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  78.9%
16
  84.2%
31
  81.6%
>=65 years
4
  21.1%
3
  15.8%
7
  18.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
49.8  (15.5) 44.9  (15.3) 47.3  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
8
  42.1%
5
  26.3%
13
  34.2%
Male
11
  57.9%
14
  73.7%
25
  65.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Mean Daily Blood Glucose
Hide Description Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Finesse Usual Injection Device
Hide Arm/Group Description:
Bolus Patch
Pen/Syringe
Overall Number of Participants Analyzed 38 38
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
8.61  (0.28) 9.02  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Finesse, Usual Injection Device
Comments A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.97 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Finesse versus usual injection device.
2.Secondary Outcome
Title Glucose Profiles Per Day
Hide Description Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Finesse Usual Injection Device
Hide Arm/Group Description:
Bolus Patch
Pen/Syringe
Overall Number of Participants Analyzed 38 38
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
3.18  (0.18) 3.63  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Finesse, Usual Injection Device
Comments This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.80 to -0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments Finesse versus usual injection device
3.Secondary Outcome
Title Insulin Delivery System Rating
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Finesse Usual Injection Device
Hide Arm/Group Description:
Bolus Patch
Pen/Syringe
Overall Number of Participants Analyzed 38 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.9  (14.5) 54.9  (17.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Finesse, Usual Injection Device
Comments Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
4.Secondary Outcome
Title Self-reported Hypoglycemic Episodes
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Finesse Usual Injection Device
Hide Arm/Group Description:
Bolus Patch
Pen/Syringe
Overall Number of Participants Analyzed 38 38
Measure Type: Number
Unit of Measure: episodes
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Finesse Usual Injection Device
Hide Arm/Group Description Bolus Patch Pen/Syringe
All-Cause Mortality
Finesse Usual Injection Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Finesse Usual Injection Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/38 (2.63%)      1/38 (2.63%)    
Gastrointestinal disorders     
Acute Pancreatitis  0/38 (0.00%)  0 1/38 (2.63%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Bronchitis  1/38 (2.63%)  1 0/38 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Finesse Usual Injection Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/38 (21.05%)      9/38 (23.68%)    
Gastrointestinal disorders     
Gastroenteritis eosinophilic  1/38 (2.63%)  1 0/37 (0.00%)  0
Tooth ache  0/38 (0.00%)  0 1/37 (2.70%)  1
Tooth disorder  0/38 (0.00%)  0 2/37 (5.41%)  2
General disorders     
Medical device site reaction  1/38 (2.63%)  1 0/37 (0.00%)  0
Infections and infestations     
Acute pyelonephritis  1/38 (2.63%)  1 0/37 (0.00%)  0
Flu  1/38 (2.63%)  1 0/37 (0.00%)  0
Pharyngitis  0/38 (0.00%)  0 1/37 (2.70%)  1
Upper respiratory infection  0/38 (0.00%)  0 4/37 (10.81%)  4
Urinary tract infection  1/38 (2.63%)  1 0/37 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Knee pain  1/38 (2.63%)  1 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  0/38 (0.00%)  0 1/37 (2.70%)  1
Cough  1/38 (2.63%)  1 0/37 (0.00%)  0
Postnasal drip  1/38 (2.63%)  1 0/37 (0.00%)  0
Respiratory disorder  1/38 (2.63%)  1 0/37 (0.00%)  0
Respiratory tract congestion  1/38 (2.63%)  1 0/37 (0.00%)  0
The short duration of the study precludes comments on longer-term outcomes.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vice President Clinical Affairs
Organization: Calibra Medical
Phone: 650-298-4750
Responsible Party: Calibra Medical, Inc.
ClinicalTrials.gov Identifier: NCT01073566     History of Changes
Other Study ID Numbers: VP-00007
First Submitted: February 22, 2010
First Posted: February 23, 2010
Results First Submitted: February 9, 2012
Results First Posted: April 9, 2012
Last Update Posted: April 9, 2012