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Completed

NCT Number: NCT00211510

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Los Angeles, Los Angeles, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paradigm 722 sensor augmented pump

Device

Subjects use the Paradigm 722 sensor augmented pump

Other names: 722 pump

Paradigm 715 insulin pump

Device

Subjects use the Paradigm 715 insulin pump

Other names: 715 pump

Primary outcomes

  1. Change in A1c From Baseline to 26 Weeks

    Time frame: 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 outcomes

  1. Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26

    Time frame: 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.

  2. Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26

    Time frame: 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

  3. Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26

    Time frame: 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

  4. Glucose Sensor Accuracy as Measured in the 722 Group

    Time frame: Baseline and 26 weeks

    Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).

  5. Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Official study 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

Acronym: STAR1

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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