Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy - Study Results

Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy (STAR3)

This study has been completed.

Study NCT00417989 Information provided by Medtronic Diabetes

First Received on January 2, 2007. Last Updated on December 6, 2011 History of Changes

Results First Received: December 24, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 1 Diabetes
Intervention:	Device: MiniMed Paradigm REAL-Time System

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
722 Sensor Augmented Pump	722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
Multiple Daily Injection (MDI)	MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year

Participant Flow: Overall Study

	722 Sensor Augmented Pump	Multiple Daily Injection (MDI)
STARTED	244 ^[1]	241
COMPLETED	224	219
NOT COMPLETED	20	22
Withdrawal by Subject	13	13
Lost to Follow-up	1	6
Protocol Violation	1	0
Death	0	1
Physician Decision	5	2

[1]	Intent to Treat include safety population & subjects with baseline & 1 post baseline A1C measurement

Baseline Characteristics

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Reporting Groups

	Description
722 Sensor Augmented Pump	722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
Multiple Daily Injection (MDI)	MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year

Baseline Measures

	722 Sensor Augmented Pump	Multiple Daily Injection (MDI)	Total
Number of Participants [units: participants]	244	241	485
Age [units: years] Mean ± Standard Deviation	32.2 ± 17.47	31.50 ± 16.50	31.90 ± 16.98
Age, Customized [units: participants]
<=18 years	77	72	149
Between 19 and 70 years	167	169	336
Gender [units: participants]
Female	104	107	211
Male	140	134	274
Region of Enrollment [units: participants]
United States	216	211	427
Canada	28	30	58

Outcome Measures

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1. Primary:

Change in A1c From Baseline to 52 Weeks [ Time Frame: Baseline and 52 weeks ]

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2. Secondary:

Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52; [ Time Frame: Baseline and 52 weeks ]

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3. Secondary:

Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52 [ Time Frame: Baseline and 52 weeks ]

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4. Secondary:

Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52; [ Time Frame: Baseline and 52 weeks ]

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5. Secondary:

Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52 [ Time Frame: Baseline and 52 weeks ]

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6. Secondary:

Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score [ Time Frame: Baseline and 52 weeks ]

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7. Secondary:

Quality of Life - Short Form-36 (SF-36v2™), General Health [ Time Frame: Baseline and 52 Weeks ]

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8. Secondary:

Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy [ Time Frame: Baseline and 52 Weeks ]

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9. Secondary:

Health Economic Outcomes (MRU) [ Time Frame: Baseline and 52 weeks ]

Results not yet posted. Anticipated Posting Date: 07/2011 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Scott Lee, M.D.
Organization: Medtronic
phone: 8185764204
e-mail: scott.w.lee@medtronic.com

No publications provided by Medtronic Diabetes

Publications automatically indexed to this study:

Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul 22;363(4):311-20. Epub 2010 Jun 29.

Responsible Party:	Medtronic Diabetes
ClinicalTrials.gov Identifier:	NCT00417989 History of Changes
Other Study ID Numbers:	CEP179/Z25
Study First Received:	January 2, 2007
Results First Received:	December 24, 2010
Last Updated:	December 6, 2011
Health Authority:	United States: Food and Drug Administration