Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00530023

Acronym

STAR2

Enrollment

Registered

2007-09-17

Start date

2006-02-28

Completion date

2006-09-30

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

DEVICEMiniMed Paradigm REAL-Time System

MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in A1C From Baseline to Week 15	Baseline and 15 weeks	Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.

Secondary

Measure	Time frame	Description
Incidence of Severe Hypoglycemia Events Baseline to Week 15	Baseline and 15 weeks	The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.
Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15	Baseline and 15 weeks	Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15	Baseline and 15 weeks	Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.
Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15	Baseline and 15 weeks	Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.

Countries

United States

Participant flow

Participants by arm

Arm	Count
722 Sensor Augmented Insulin Pump 722 MiniMed Paradigm REAL-Time System	14
Multiple Daily Injections (MDI) Continue with current Multiple Daily Injection therapy	15
Total	29

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Multiple Daily Injections (MDI)	722 Sensor Augmented Insulin Pump	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	4 Participants	1 Participants	5 Participants
Age, Categorical Between 18 and 65 years	11 Participants	13 Participants	24 Participants
Age Continuous	49.7 years STANDARD_DEVIATION 13.51	45.1 years STANDARD_DEVIATION 12.59	47.4 years STANDARD_DEVIATION 13.05
Region of Enrollment United States	15 participants	14 participants	29 participants
Sex: Female, Male Female	10 Participants	6 Participants	16 Participants
Sex: Female, Male Male	5 Participants	8 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 14	0 / 15
serious Total, serious adverse events	1 / 14	3 / 15

Outcome results

Primary

Change in A1C From Baseline to Week 15

Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.