Diabetes MellitusPhase 2NCT01073566
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
A Phase 2 study testing Finesse and Pen/Syringe (Usual injection device) in people with Diabetes Mellitus, run by Calibra Medical, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Finesse and Pen/Syringe (Usual injection device)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2010to Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus on intensive insulin therapy
Who cannot join
- Insulin pump therapy
- Current use of NPH or regular insulin
- Severe hypoglycemic episodes in prior 6 months
- Unstable cardiac disease, hepatic, or renal function
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University
Chicago, Illinois, 60611
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
International Diabetes Center at Park Nicollet
Minneapolis, Minnesota, 55416
California Pacific Medical Center
San Francisco, California, 94110
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Finesse, Pen/Syringe (Usual injection device)
- Keywords
- Autoimmune Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases, Insulin, Metabolic Diseases
- Medical subject headings
- Diabetes Mellitus, Autoimmune Diseases, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases, Insulin Resistance, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinesseDevice
Also called Insulin Bolus Patch
Finesse Insulin Delivery Patch
Pen/Syringe (Usual injection device)Device
Also called Insulin pen, Insulin syringe, Insulin injection device
Pen/Syringe
| Study group | Role | What they receive |
|---|---|---|
| Finesse | Experimental | Finesse Insulin Delivery Patch Receives: Device: Finesse |
| Usual injection device | Active comparator | Pen/Syringe Receives: Device: Pen/Syringe (Usual injection device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily Blood Glucose
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
Measured: 6 weeks
Secondary outcomes (3)
Glucose Profiles Per Day
Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calibra Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nancy Bohannon, MD, Med. Corp., Henry Ford Health System, Northwestern University, University of Texas Southwestern Medical Center, International Diabetes Center at Park Nicollet
- Responsible party
- Sponsor
- Investigators
- Vice President Clinical Affairs, Study director, Calibra Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073566
- Sponsor's protocol ID
- VP-00007
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2010
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21732797
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01073566
- Acronym / sponsor ID
- VP-00007
- Conditions
- Diabetes Mellitus
- Keywords
- Autoimmune Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases, Insulin, Metabolic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Calibra Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nancy Bohannon, MD, Med. Corp., Henry Ford Health System, Northwestern University, University of Texas Southwestern Medical Center, International Diabetes Center at Park Nicollet
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Posted 9 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finesse | Experimental | Device: FinesseFinesse Insulin Delivery Patch |
| Usual injection device | Active comparator | Device: Pen/Syringe (Usual injection device)Pen/Syringe |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes mellitus on intensive insulin therapy
Key exclusion criteria (4 listed)
- Insulin pump therapy
- Current use of NPH or regular insulin
- Severe hypoglycemic episodes in prior 6 months
- Unstable cardiac disease, hepatic, or renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinesseAlso: Insulin Bolus PatchFinesse Insulin Delivery Patch | Device | Finesse |
| Pen/Syringe (Usual injection device)Also: Insulin pen, Insulin syringe, Insulin injection devicePen/Syringe | Device | Usual injection device |
Primary outcome
Mean Daily Blood Glucose
Time frame: 6 weeks
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
3 secondary outcomes
Glucose Profiles Per Day
Time frame: 6 weeks
Insulin Delivery System Rating
Time frame: 6 weeks
Self-reported Hypoglycemic Episodes
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21732797Bohannon 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vice President Clinical Affairs study director
Calibra Medical, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finesse and Pen/Syringe (Usual injection device) in people with Diabetes Mellitus, run by Calibra Medical, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Daily Blood Glucose (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.