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Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003898
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Device: Medtronic MiniMed 530G Insulin Pump Not Applicable

Detailed Description:
Multi-center trial is initiated to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump (Medtronic MiniMed® 530G insulin pump) in patients 16 and older with insulin requiring diabetes over a period of one year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects are assigned to treatment with the Medtronic 530G Insulin Pump
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data
Actual Study Start Date : November 26, 2013
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medtronic MiniMed 530G Insulin Pump
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Device: Medtronic MiniMed 530G Insulin Pump



Primary Outcome Measures :
  1. Mean Change in A1C From Baseline to 1 Year [ Time Frame: 1 year ]

    Comparison of A1C measurement from baseline to end of study in the CEP266 study population.

    The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.



Secondary Outcome Measures :
  1. Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7% [ Time Frame: 1 year ]
    Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.

  2. Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9% [ Time Frame: 1 year ]
    Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%

  3. Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9% [ Time Frame: 1 year ]
    Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c > 9%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is age 16 or older at time of screening
  2. Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.
  3. Subject is currently on pump therapy.
  4. Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.
  5. Subject is willing to complete all study related activities
  6. Subject is willing to upload data every 21 days from the study pump
  7. Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend's computer system with Internet access.
  8. Subject is able (by insurance or financial means) to cover the initial investment and ongoing cost of the 530G insulin pump and consumables, CGM, Bayer CONTOUR Next Link RF enabled meter and supplies for the length of the study- 1 year.

Exclusion Criteria:

  1. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks.
  2. Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study
  3. Subject is being treated for hyperthyroidism at time of screening
  4. Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
  5. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. If TSH is out of range, Free T3 and Free T4 will be tested. Subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range.
  6. Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
  7. Subject is currently abusing illicit drugs
  8. Subject is currently abusing prescription drugs
  9. Subject is currently abusing alcohol
  10. Subject has sickle cell disease or hemoglobinopathy
  11. Subject has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  12. Subject diagnosed with current eating disorder such as anorexia or bulimia
  13. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
  14. Subject is on dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003898


Locations
Show Show 43 study locations
Sponsors and Collaborators
Medtronic Diabetes
Investigators
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Study Director: Scott Lee, MD Medtronic Diabetes
  Study Documents (Full-Text)

Documents provided by Medtronic Diabetes:
Study Protocol  [PDF] October 10, 2017
Statistical Analysis Plan  [PDF] February 15, 2018

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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02003898    
Other Study ID Numbers: CEP266
First Posted: December 6, 2013    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medtronic Diabetes:
Diabetes
Insulin pump
Threshold Suspend
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs