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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00211510

Acronym

STAR1

Enrollment

146

Registered

2005-09-21

Start date

2005-06-30

Completion date

2007-02-28

Last updated

2017-06-12

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

Conditions

Type 1 Diabetes

Keywords

Diabetes, Continuous Glucose Monitoring, Glycemic Control

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).

Interventions

DEVICEParadigm 722 sensor augmented pump

Subjects use the Paradigm 722 sensor augmented pump

DEVICEParadigm 715 insulin pump

Subjects use the Paradigm 715 insulin pump

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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).
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Paradigm 722 Sensor Augmented Pump subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	72
Paradigm 715 Insulin Pump subjects will use the Paradigm 715 insulin pump for insulin infusion	74
Total	146

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Physician Decision	3	1
Overall Study	Withdrawal by Subject	3	1

Baseline characteristics

Characteristic	Paradigm 715 Insulin Pump	Paradigm 722 Sensor Augmented Pump	Total
Age, Categorical <=18 years	23 Participants	20 Participants	43 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	51 Participants	52 Participants	103 Participants
Age, Continuous	32.9 years STANDARD_DEVIATION 16.3	32 years STANDARD_DEVIATION 14.6	32.4 years STANDARD_DEVIATION 15.4
Region of Enrollment United States	74 participants	72 participants	146 participants
Sex: Female, Male Female	46 Participants	38 Participants	84 Participants
Sex: Female, Male Male	28 Participants	34 Participants	62 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	25 / 72	7 / 74
serious Total, serious adverse events	14 / 72	8 / 74

Outcome results

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.