Feasibility Study of Effective Methods for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness - Full Text View

Sponsored by:	Medtronic Diabetes
Information provided by:	Medtronic Diabetes
ClinicalTrials.gov Identifier:	NCT00530023

Purpose

Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus subjects continuing to administer insulin in multiple dose injections. Evaluate the educational materials and time required for training subjects naïve to continuous subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation for a large multi-center clinical trial

Condition	Intervention	Phase
Type 1 Diabetes	Device: MiniMed Paradigm REAL-Time System	Phase IV

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Pilot Study To Identify Effective Methods Of Training Pump Naïve Subjects To Use The Paradigm® 722 System And To Describe Clinical Effectiveness Compared To Subjects Continuing With Multiple Dose Injections (MDI) of Insulin

Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:

Change in A1C [ Time Frame: 15 weeks ]

Secondary Outcome Measures:

Incidence and frequency of severe hypoglycemia [ Time Frame: 15 weeks ]
Quality of Life survey analysis [ Time Frame: 15 weeks ]
Results of user evaluation questionnaires [ Time Frame: 15 weeks ]

Enrollment:	29
Study Start Date:	February 2006
Study Completion Date:	September 2006

Arms	Assigned Interventions
1. 722: Active Comparator MiniMed Paradigm REAL-Time System	Device: MiniMed Paradigm REAL-Time System MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
2. MDI: No Intervention Continue with Multiple Daily Injections

Detailed Description:

Many subjects with Type 1 diabetes continue to manage their disease utilizing multiple daily injections, but despite frequent blood glucose checks, are unable to control their glycemic variability or lower their A1C levels. The MiniMed Paradigm REAL-Time System transmits sensor glucose values to the insulin pump every 5 minutes, allowing users to view their current glucose values as well as glycemic excursions and trends over a 24-hour period. The System will also alert users of high and low glucose levels, allowing subjects and their clinicians to make carefully monitored modifications to therapy. Additionally, data can be uploaded from the monitor into a personal computer, allowing the subject and clinician to see a complete picture of trends over time.

Subjects learning this technology would require a new approach to training if they were to master operation of an insulin pump, make effective use of the sensor technology and understand the complete picture provided by the software component. Subjects will be trained to first use the insulin pump, add the sensor and then utilize the software and the effectiveness of the training methods and timing will be measured using questionnaires designed to evaluate understanding of the device, Self Efficacy and User Acceptance. The group wearing the System will also be compared to subjects that continue on their current MDI therapy over a 15-week time period.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is between 18 - 70 years of age (inclusive)
Subject is diagnosed with Type 1 Diabetes Mellitus as determined by the Investigator.
Diabetes is diagnosed > (greater or equal to) six (6) months prior to study entry.
A1C > 7.5% (greater than or equal to) as measured by the Central Laboratory at Screening Visit 1.
Subject currently requires insulin administration by injection > (greater or equal to) three (3) times daily.
Subject is currently (over past 3 months) performing an average of four (4) blood glucose measurements per day, as determined and documented by the investigator
Subject has been treated in the investigator's practice or in a referring endocrinologist's practice for at least 6 months prior to the study
Subject is fluent in speaking, understanding, and reading English.
Subject is able and willing to perform the study procedures and agrees to wear sensors at least five (5) days per week (722 Arm only) during the study period.
Subject is able to use the study devices (722 Arm only) as labeled
Subject has reviewed and signed the Informed consent, HIPPA Authorization, and California Experimental Subject's Bill of Rights (California only).
Subject has the capability to upload their insulin pumps or glucose meters every two weeks; access to the Internet and specific computer system requirements are necessary to participate in the study

Exclusion Criteria:

Subject is pregnant or planning to become pregnant during the course of the study.
Subject has a history of tape allergies that have not been resolved.
Subject self-reports any skin abnormality (i.e. psoriasis, rash, and staphylococcus infection).
Subject has any additional condition(s) (medical, social, or psychosocial) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing or complying with the study requirements.
Subject is currently or within past 4 weeks participated in an investigational study (drug or device).

Subject has a history of tape allergies that have not been resolved.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530023

Locations

United States, California
Diabetes Treatment Center, Loma Linda University
Loma Linda, California, United States, 92354
United States, Oregon
Portland Diabetes & Endocrinology
Portland, Oregon, United States, 97210

Sponsors and Collaborators

Medtronic Diabetes

Investigators

Study Director:

Alan O Marcus, MD

Medtronic Diabetes

More Information

Study ID Numbers:	CEP195/Z25
Study First Received:	September 13, 2007
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00530023
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009