Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Device: Bolus Insulin Patch (Calibra Finesse)Device: Insulin Pen (Novo-Nordisk FlexPen®)
- Registration Number
- NCT02542631
- Lead Sponsor
- Calibra Medical, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- Clinical diagnosis of T2DM
- Treated with basal insulin for ≥ 6 months, with current dose stable for ≥ 6 weeks of ≥ 0.3 U/kg/day, with or without anti-hyperglycemic agents and in whom the Investigator feels advancement from basal to basal and bolus therapy is needed for the patient
- A1C 7.5-11.0% by central lab value at screening visit
- Already perform self-monitoring of blood glucose (SMBG) and willing to test blood glucose (BG) over the course of the study
- Body Mass Index of ≤ 40 kg/m2
- Currently on or has been treated in the past year with insulin regimens that include bolus insulins except the need for insulins in the settings of acute illness or hospitalization
- History of type 1 diabetes mellitus (T1DM), or diabetic ketoacidosis (DKA), or secondary forms of diabetes such as cystic fibrosis
- Known hypersensitivity or allergy to insulin-glargine or its excipients or any other insulins
- Two or more severe hypoglycemic episodes within the prior year
- Hypoglycemia unawareness defined by history
- History of proliferative diabetic retinopathy
- Is currently unstable and/or has moderate-to-severe medical illness in the Investigator's judgment
- Uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 100 mmHg at screening
- History of recent major surgery within 6 months, or minor surgery within 3 months (such as appendectomy) prior to screening visit, or a planned surgery during the study period
- History of bariatric surgery
- Active chronic infections
- Women of child-bearing age who are pregnant, planning pregnancy, breast-feeding, or, if capable of pregnancy, are not practicing contraception if heterosexually active
- Known hypersensitivity to plastics/polymers/adhesives
- Known difficulties with adherence of adhesives, bandages, or dressings
- Participated in any research study within the past 30 days
- Currently participating in another investigational trial
- Use of short term or chronic systemic steroids within three months of entry into the study or likelihood that same might be required during the conduct of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bolus Insulin Patch (Calibra Finesse) Bolus Insulin Patch (Calibra Finesse) Use of the wearable patch to deliver meal-related bolus insulin dose Insulin Pen (Novo-Nordisk FlexPen®) Insulin Pen (Novo-Nordisk FlexPen®) Use of the pen device to deliver meal-related bolus insulin dose
- Primary Outcome Measures
Name Time Method Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy 24 weeks Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy
- Secondary Outcome Measures
Name Time Method Number of Patients With A1C ≤7.0% at Week 24 24 weeks Number of patients with A1C ≤7.0% at week 24
Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24 24 weeks Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients)
Change in A1C From Baseline to Week 44 44 weeks Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy
Number of Patients With A1C ≤7.0% at Week 44 44 weeks Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy
Change in A1C From Week 24 to Week 44 44 weeks Change in A1C from week 24 to week 44 after basal and bolus insulin therapy
Number of Participants With Severe Hypoglycemic Event 44 weeks An event requiring the assistance of another person to actively administer carbohydrate (including IV dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Trial Locations
- Locations (52)
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Physicians Research Associates
🇺🇸Lawrenceville, Georgia, United States
BAG Unterm Heilig Kreuz Unterm Heilig Kreuz
🇩🇪Fulda, Germany
Lapeyronie Hospital, University Hospital Montpellier
🇫🇷Montpellier cedex 5, France
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Royal United Hospital, Diabetes & Lipid Research Wolfson Centre
🇬🇧Bath, United Kingdom
Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.
🇩🇪Mainz, Germany
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center PA
🇺🇸Idaho Falls, Idaho, United States
Northwestern University The Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County Diabetes Center
🇺🇸Chicago, Illinois, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Park Nicollet Institute International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
University Diabetes and Endocrine Consultants
🇺🇸Chattanooga, Tennessee, United States
Forth Valley Royal Hospital Dept. of Diabetes
🇬🇧Larbert, United Kingdom
CHU de Nantes-Hospital Nord Laennec
🇫🇷Saint-Herblain, France
Denver VA Medical Center
🇺🇸Denver, Colorado, United States
Diabetes Research Institute Mills-Peninsula Health Service
🇺🇸San Mateo, California, United States
Marin Endocrine Care and Research
🇺🇸Greenbrae, California, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
National Research Institute - Wilshire
🇺🇸Los Angeles, California, United States
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
🇺🇸Escondido, California, United States
Endocrine Research Solutions, Inc
🇺🇸Roswell, Georgia, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸Des Moines, Iowa, United States
VA Medical Center Cleveland
🇺🇸Cleveland, Ohio, United States
Diabeteszentrum DO-Diabetologisch
🇩🇪Dortmund, Germany
Great Plains Diabetes
🇺🇸Wichita, Kansas, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Kentucky Diabetes Endocrinology Center
🇺🇸Lexington, Kentucky, United States
Medstar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
South Texas Veterans Health Care System
🇺🇸San Antonio, Texas, United States
Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust
🇬🇧Blackburn, United Kingdom
Chorley and South Ribble Hospital
🇬🇧Chorley, United Kingdom
Private Practice-Larry Stonesifer
🇺🇸Federal Way, Washington, United States
Texas Diabetes & Endocrinology, P.A.- Austin
🇺🇸Austin, Texas, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Baylor Endocrine Center
🇺🇸Dallas, Texas, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Ninewells Hospital & Medical School Diabetes Support Unit
🇬🇧Dundee, United Kingdom
Leicester General Hospital Leicester Diabetes Centre
🇬🇧Leicester, United Kingdom
Progressive Clinical Research
🇺🇸Bountiful, Utah, United States
Danville Internal Medicine
🇺🇸Danville, Virginia, United States
GHMP les Portes du Sud
🇫🇷Venissieux, France
Hopital Avicenne
🇫🇷Bobigny, France
Hopital Saint-Andre
🇫🇷Bordeaux, France
Diabetes & Glandular Disease Clinic, P.A.
🇺🇸San Antonio, Texas, United States
Consano Clinical Research
🇺🇸San Antonio, Texas, United States
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications
🇫🇷Paris, France
Hopital Hotel-Dieu Site Harfleur
🇫🇷Le Creusot, France
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom