NCT01073566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2 diabetes-mellitus

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 9, 2012

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

February 22, 2010

Results QC Date

February 9, 2012

Last Update Submit

January 31, 2025

Conditions

Diabetes Mellitus

Keywords

Autoimmune DiseasesDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersImmune System DiseasesInsulinMetabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • Mean Daily Blood Glucose

    Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose

    6 weeks

Secondary Outcomes (3)

  • Glucose Profiles Per Day

    6 weeks

  • Insulin Delivery System Rating

    6 weeks

  • Self-reported Hypoglycemic Episodes

    6 weeks

Study Arms (2)

Finesse

EXPERIMENTAL

Finesse Insulin Delivery Patch

Device: Finesse

Usual injection device

ACTIVE COMPARATOR

Pen/Syringe

Device: Pen/Syringe (Usual injection device)

Interventions

FinesseDEVICE

Finesse Insulin Delivery Patch

Also known as: Insulin Bolus Patch
Finesse
Pen/Syringe (Usual injection device)DEVICE

Pen/Syringe

Also known as: Insulin pen, Insulin syringe, Insulin injection device
Usual injection device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus on intensive insulin therapy

You may not qualify if:

  • Insulin pump therapy
  • Current use of NPH or regular insulin
  • Severe hypoglycemic episodes in prior 6 months
  • Unstable cardiac disease, hepatic, or renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

California Pacific Medical Center

San Francisco, California, 94110, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

International Diabetes Center at Park Nicollet

Minneapolis, Minnesota, 55416, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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.

    PMID: 21732797RESULT

MeSH Terms

Conditions

Diabetes MellitusAutoimmune DiseasesEndocrine System DiseasesGlucose Metabolism DisordersImmune System DiseasesInsulin ResistanceMetabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesHyperinsulinism

Limitations and Caveats

The short duration of the study precludes comments on longer-term outcomes.

Results Point of Contact

Title
Vice President Clinical Affairs
Organization
Calibra Medical
ddreon@calibra.com
650-298-4750

Study Officials

  • Vice President Clinical Affairs

    Calibra Medical, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 4, 2025

Results First Posted

April 9, 2012

Record last verified: 2025-01

Locations

US(5)