Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Paradigm 722 sensor augmented pump; Device: Paradigm 715 insulin pump

• Registration Number: NCT00211510
• Lead Sponsor: Medtronic Diabetes

Brief Summary

The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.

Detailed Description

Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.

Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-08
• Study Completion: 2007-02
• Results First Submitted: 2011-04-01
• Results First Submitted QC: 2011-04-04
• Results First Posted: 2011-04-29
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Age 12 - 80 years
• Type 1 Diabetes Mellitus diagnosed at least 1 year ago
• Using insulin infusion pump for past 6 months minimum
• Performing minimum 4 blood glucose tests per day
• Agree to treat to A1c targets
• Read and understand English

Exclusion Criteria

• Pregnant or planning pregnancy
• History of unresolved tape allergy or skin conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paradigm 722 sensor augmented pump	Paradigm 722 sensor augmented pump	subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring
Paradigm 715 insulin pump	Paradigm 715 insulin pump	subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin

Primary Outcome Measures

Name	Time	Method
Change in A1c From Baseline to 26 Weeks	Baseline and 26 weeks	Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.

Secondary Outcome Measures

Name	Time	Method
Glucose Sensor Accuracy as Measured in the 722 Group	Baseline and 26 weeks	Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26	Baseline and 26 weeks	Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26	Baseline and 26 weeks	Hypoglycemia is defined as a recorded blood glucose event \<70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26
Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups	Baseline and 26 weeks	Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.
Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26	Baseline and 26 weeks	Hyperglycemia is defined as a recorded blood glucose event \> 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26

Trial Locations

Locations (7)

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

The Endocrine Group; 🇺🇸 Albany, New York, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Diabetes and Glandular Diabetes Research Associates; 🇺🇸 San Antonio, Texas, United States

Stanford University; 🇺🇸 Stanford, California, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States