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

Type 1 Diabetes Clinical Trial

— STAR1  

Official title:

Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-center, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211510
• Other study ID #: CEP 178/Z25/A2
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 28, 2011
• Start date: June 2005
• Est. completion date: February 2007

Study information

• Verified date: April 2011
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Paradigm 722 Sensor-augmented pump
Subjects transferred from current insulin pump to use the Paradigm 722 sensor augmented pump
• Paradigm 715 insulin pump
Subjects transferred from their current insulin pump to use the paradigm 715 insulin pump

Locations

Country	Name	City	State
United States	The Endocrine Group	Albany	New York
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Diabetes and Glandular Diabetes Research Associates	San Antonio	Texas
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1c From Baseline to 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.	Baseline and 26 weeks	No
Secondary	Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26	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.	Baseline and 26 weeks	Yes
Secondary	Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26	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	Baseline and 26 weeks	No
Secondary	Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26	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	Baseline and 26 weeks	No
Secondary	Glucose Sensor Accuracy as Measured in the 722 Group	Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).	Baseline and 26 weeks	No
Secondary	Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups	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.	Baseline and 26 weeks	No