Phase 4
N=29
Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00530023 ↗Enrolled (actual)
29
Serious AEs
13.8%
Results posted
Jun 2011
Primary outcome: Primary: Change in A1C From Baseline to Week 15 — -1.7; -1.0 percent glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MiniMed Paradigm REAL-Time System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic MiniMed, Inc.
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in A1C From Baseline to Week 15 |
-1.7; -1.0 | — |
| SECONDARY Incidence of Severe Hypoglycemia Events Baseline to Week 15 |
0; 1 | — |
| SECONDARY Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15 |
73.8; 41.0 | — |
| SECONDARY Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15 |
83.3; 33.3 | — |
| SECONDARY Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15 |
-10.57; -17.79 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT00530023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.