NCT00211510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

April 29, 2011

Completed
Last Updated

June 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

September 12, 2005

Results QC Date

April 1, 2011

Last Update Submit

May 10, 2017

Conditions

Type 1 Diabetes

Keywords

DiabetesContinuous Glucose MonitoringGlycemic Control

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26

    Baseline and 26 weeks

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

    Baseline and 26 weeks

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

    Baseline and 26 weeks

  • Glucose Sensor Accuracy as Measured in the 722 Group

    Baseline and 26 weeks

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

    Baseline and 26 weeks

Study Arms (2)

Paradigm 722 sensor augmented pump

EXPERIMENTAL

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

Device: Paradigm 722 sensor augmented pump

Paradigm 715 insulin pump

ACTIVE COMPARATOR

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

Device: Paradigm 715 insulin pump

Interventions

Paradigm 722 sensor augmented pumpDEVICE

Subjects use the Paradigm 722 sensor augmented pump

Also known as: 722 pump
Paradigm 722 sensor augmented pump
Paradigm 715 insulin pumpDEVICE

Subjects use the Paradigm 715 insulin pump

Also known as: 715 pump
Paradigm 715 insulin pump

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

The Endocrine Group

Albany, New York, 12206, United States

Location

Diabetes and Glandular Diabetes Research Associates

San Antonio, Texas, 78229, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
John Shin, PhD, MBA
Organization
Medtronic, Inc
john.shin@medtronic.com
818 576 4019

Study Officials

  • Scott W Lee, MD

    Medtronic

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2006

Study Completion

February 1, 2007

Last Updated

June 12, 2017

Results First Posted

April 29, 2011

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(7)