Clinical trial NCT00530023: Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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.

Primary outcomes:
measure: Change in A1C From Baseline to Week 15
timeFrame: Baseline and 15 weeks
Secondary outcomes:
measure: Incidence of Severe Hypoglycemia Events Baseline to Week 15
timeFrame: Baseline and 15 weeks
measure: Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15
timeFrame: Baseline and 15 weeks
measure: Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15
timeFrame: Baseline and 15 weeks
measure: Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15
timeFrame: Baseline and 15 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Diabetes Treatment Center, Loma Linda University
state: California
city: Portland
country: United States
facility: Portland Diabetes & Endocrinology
state: Oregon
Study officials:
affiliation: Medtronic Diabetes
name: Scott W Lee, MD
role: STUDY_DIRECTOR
References: