Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes (STAR1)

Medtronic

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Paradigm 722 sensor augmented pump; Device: Paradigm 715 insulin pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT00211510

CEP 178/Z25/A2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 146 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

146 participants in 2 patient groups

Paradigm 722 sensor augmented pump

Experimental group

Description:

subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring

Treatment:

Device: Paradigm 722 sensor augmented pump

Paradigm 715 insulin pump

Active Comparator group

Description:

subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin

Treatment:

Device: Paradigm 715 insulin pump