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Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents
To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.
Patients sub-optimally controlled on basal insulin (with/without other antihyperglycemic agents (AHAs)) will be randomized 1:1 to either Finesse or pen to initiate bolus insulin dosing and followed for a 44-week intervention period. Patients will have both basal and bolus doses of insulin adjusted throughout the trial, as is clinically indicated, based on an easy to follow insulin dosing algorithm. After the final endpoint evaluation at week 44, patients will crossover to the alternate bolus insulin delivery device for 4 weeks and complete a patient preference survey at week 48.
Age
22 - 75 years
Sex
ALL
Healthy Volunteers
No
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
Escondido, California, United States
Marin Endocrine Care and Research
Greenbrae, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
Diabetes Research Institute Mills-Peninsula Health Service
San Mateo, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Denver VA Medical Center
Denver, Colorado, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Physicians Research Associates
Lawrenceville, Georgia, United States
Start Date
August 1, 2015
Primary Completion Date
August 31, 2017
Completion Date
August 31, 2017
Last Updated
February 4, 2025
278
ACTUAL participants
Bolus Insulin Patch (Calibra Finesse)
DEVICE
Insulin Pen (Novo-Nordisk FlexPen®)
DEVICE
Lead Sponsor
Calibra Medical, Inc.
Collaborators
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062