ClinicalTrials.gg
Sign In
CompletedNCT02003898Updated Mar 5, 2019Results posted

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

An interventional study of Medtronic MiniMed 530G Insulin Pump in Diabetes, sponsored by Medtronic MiniMed, Inc.. Completed at 43 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Medtronic MiniMed, Inc. (part of Medtronic) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
372
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes

Browse trials for

Keywords

  • Diabetes
  • Insulin pump
  • Threshold Suspend
03

In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 372 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Medtronic MiniMed, Inc. is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

First submitted after Medtronic MiniMed, Inc. became part of Medtronic.

Browse Medtronic MiniMed, Inc. studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
372 participants (actual)

Study arms

  • Experimental
    Medtronic MiniMed 530G Insulin Pump

    All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.

    Device: Medtronic MiniMed 530G Insulin Pump

Interventions

  • DeviceMedtronic MiniMed 530G Insulin Pump
06

What researchers measure

Primary outcomes

  1. Mean Change in A1C From Baseline to 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.

    Time frame: 1 year

Secondary outcomes

  1. Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%

    Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.

    Time frame: 1 year

  2. Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%

    Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%

    Time frame: 1 year

  3. Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%

    Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c \> 9%

    Time frame: 1 year

07

Results

Posted Mar 5, 2019

Participant flow

Participant flow — Overall Study
MilestoneMedtronic MiniMed 530G Insulin Pump
Started372
Completed305
Not completed67
Withdrew: Death3
Withdrew: Lost to follow-up12
Withdrew: Withdrawal by subject52

Outcome measures

PrimaryMean Change in A1C From Baseline to 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.

Time frame:
1 year
Reported as:
Mean · percentage
Mean Change in A1C From Baseline to 1 Year
percentageMedtronic MiniMed 530G Insulin Pump
Mean Change in A1C From Baseline to 1 Year0.034 (-0.03 to 0.098)
Statistical analysis
  • Medtronic MiniMed 530G Insulin Pump · Mean difference (net): 0.034 · 95% CI -0.03 to 0.098
SecondaryMean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%

Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.

Time frame:
1 year
Reported as:
Mean · percentage
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%
percentageMedtronic MiniMed 530G Insulin Pump
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%0.32 ± 0.53
SecondaryMean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%

Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%

Time frame:
1 year
Reported as:
Mean · percentage
Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%
percentageMedtronic MiniMed 530G Insulin Pump
Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%-0.04 ± 0.67
SecondaryMean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%

Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c \> 9%

Time frame:
1 year
Reported as:
Mean · percentage
Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%
percentageMedtronic MiniMed 530G Insulin Pump
Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%-0.39 ± 0.96

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Medtronic MiniMed 530G Insulin Pump3/372 (0.8%)19/372 (5.1%)37/372 (9.9%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventMedtronic MiniMed 530G Insulin Pump
Diabetic ketoacidosisMetabolism and nutrition disorders5/372
HyperglycaemiaMetabolism and nutrition disorders4/372
Acute myocardial infarctionCardiac disorders1/372
Altered state of consciousnessNervous system disorders1/372
Bile duct obstructionHepatobiliary disorders1/372
Cellulitis staphylococcalInfections and infestations1/372
Chest painGeneral disorders1/372
DeathGeneral disorders1/372
Gastric ulcerGastrointestinal disorders1/372
HypoglycaemiaMetabolism and nutrition disorders1/372
Most frequent other events
Showing 10 of 20
Most frequent other events
EventMedtronic MiniMed 530G Insulin Pump
HyperglycaemiaMetabolism and nutrition disorders10/372
Puncture site haemorrhageGeneral disorders9/372
HypoglycaemiaMetabolism and nutrition disorders4/372
ContusionInjury, poisoning and procedural complications2/372
Skin infectionInfections and infestations2/372
Skin irritationSkin and subcutaneous tissue disorders2/372
Abscess limbInfections and infestations1/372
CellulitisInfections and infestations1/372
ConvulsionNervous system disorders1/372
DermatophytosisInfections and infestations1/372

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Medtronic MiniMed 530G Insulin Pump
Mean45.5 ± 15.9
Sex: Female, Male
Sex: Female, Male(Participants)Medtronic MiniMed 530G Insulin Pump
Female201
Male171
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Medtronic MiniMed 530G Insulin Pump
Hispanic or Latino15
Not Hispanic or Latino351
Unknown or Not Reported6
Region of Enrollment
Region of Enrollment(participants)Medtronic MiniMed 530G Insulin Pump
United States372
08

Study locations

43 sites
  • Medical Investigations, Inc.
    Little Rock, Arkansas 72205, United States
  • AMCR Institute
    Escondido, California 92026, United States
  • Valley Research
    Fresno, California 93720, United States
  • Center of Excellence in Diabetes & Endocrinology
    Sacramento, California 98521, United States
  • So Cal Diabetes
    Torrance, California 90505, United States
  • Barbara Davis Center (1)
    Aurora, Colorado 80045, United States
  • Barbara Davis Center (2)
    Aurora, Colorado 80045, United States
  • East Coast Institute for Research
    Jacksonville, Florida 32204, United States
  • Endocrine Associates of Florida, P.A.
    Lake Mary, Florida 32746, United States
  • TLC Diabetes Healthcare Consultants & Education Inc.
    Naples, Florida 34109, United States
  • Pediatric Endocrine Associates
    Tampa, Florida 33607, United States
  • Atlanta Diabetes Associates
    Atlanta, Georgia 30318, United States
  • East Alabama Endocrinology PC
    Columbus, Georgia 31907, United States
  • Endocrine Research Solutions
    Roswell, Georgia 30076, United States
  • The University of Chicago
    Chicago, Illinois 60637, United States
  • Isaiah Pittman IV, MD
    Terre Haute, Indiana 47802, United States
  • Good Samaritan Hospital Physician Services
    Vincennes, Indiana 47591, United States
  • Iowa Diabetes and Endocrinology Center
    Des Moines, Iowa 50314, United States
  • Imperial Health
    Lake Charles, Louisiana 70601, United States
  • Eastern Shore Diabetes and Endocrinology Center
    Salisbury, Maryland 21804, United States
  • University of Michigan Diabetes Research Center
    Ann Arbor, Michigan 48105, United States
  • Grunberger Diabetes Institute
    Bloomfield Hills, Michigan 48302, United States
  • Spectrum Health System
    Grand Rapids, Michigan 49546, United States
  • International Diabetes Center
    Minneapolis, Minnesota 55416, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • The Diabetes Center
    Ocean Springs, Mississippi 39564, United States
  • The Children's Mercy Hospital
    Kansas City, Missouri 64111, United States
  • Billings Clinic
    Billings, Montana 59107, United States
  • Glacier View Research Institute-Endocrinology
    Kalispell, Montana 59901, United States
  • Complete Endocrinology
    Lincoln, Nebraska 68506, United States
  • Diabetes, Endocrinology, Metabolism Specialties
    Teaneck, New Jersey 07666-3445, United States
  • Winthrop University Hospital
    Mineola, New York 11501, United States
  • Rochester General Hospital
    Rochester, New York 14621, United States
  • Joslin Diabetes Center
    Syracuse, New York 13210, United States
  • University at Buffalo, The State University of New York
    Williamsville, New York 14221, United States
  • Physicians East, PA
    Greenville, North Carolina 27834, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • AM Diabetes and Endocrinology Center
    Bartlett, Tennessee 38133, United States
  • Endeavor Clinical Trials
    San Antonio, Texas 78229, United States
  • Consano Clinical Research, LLC
    San Antonio, Texas 78258, United States
  • Northeast Clinical Research of San Antonio, LLC
    Schertz, Texas 78154, United States
  • Southwestern Vermont Health Care
    Bennington, Vermont 05201, United States
  • Tri-Cities Diabetes and Endocrinology Center
    Richland, Washington 99352, United States
09

References and documents

Study documents

  • Study protocol · Oct 10, 2017
  • Statistical analysis plan · Feb 15, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2013 to primary completion in Feb 2018, 50 months.

Results were first posted in Mar 2019, 1 year after primary completion.

Of 192 industry-sponsored interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's 50 months is above that.

Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2013
First posted
Dec 6, 2013
StartActual
Nov 26, 2013
Primary completionActual
Feb 20, 2018
CompletionActual
Feb 20, 2018
Results first posted
Mar 5, 2019
Last update
Mar 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02003898
Lead sponsor
Medtronic MiniMed, Inc.
Responsible party
Sponsor
First posted
Dec 6, 2013
Start date
Nov 26, 2013
Primary completion
Feb 20, 2018
Completion
Feb 20, 2018
Results posted
Mar 5, 2019
Last update
Mar 5, 2019

Study contacts

Scott Lee, MD
study director · Medtronic MiniMed, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus →

Other studies from this sponsor

Medtronic MiniMed, Inc. →

Start the discussion