DiabetesNCT02003898
Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data
A study testing Medtronic MiniMed 530G Insulin Pump in people with Diabetes, run by Medtronic MiniMed, Inc. at 43 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Medtronic MiniMed 530G Insulin Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 43 sitesUnited States
- Study dates
- 26 Nov 2013to 20 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is age 16 or older at time of screening
- Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.
- Subject is currently on pump therapy.
- Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.
- Subject is willing to complete all study related activities
- Subject is willing to upload data every 21 days from the study pump
- 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.
- 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.
Who cannot join
- 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.
- 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
- Subject is being treated for hyperthyroidism at time of screening
- Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
- 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.
- 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
Show all 14Show fewer
- Subject is currently abusing illicit drugs
- Subject is currently abusing prescription drugs
- Subject is currently abusing alcohol
- Subject has sickle cell disease or hemoglobinopathy
- 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
- Subject diagnosed with current eating disorder such as anorexia or bulimia
- Subject has been diagnosed with chronic kidney disease that results in chronic anemia
- Subject is on dialysis
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
University of Michigan Diabetes Research Center
Ann Arbor, Michigan, 48105
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center (1)
Aurora, Colorado, 80045
Barbara Davis Center (2)
Aurora, Colorado, 80045
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133
Southwestern Vermont Health Care
Bennington, Vermont, 05201
Billings Clinic
Billings, Montana, 59107
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, 48302
The University of Chicago
Chicago, Illinois, 60637
East Alabama Endocrinology PC
Columbus, Georgia, 31907
Iowa Diabetes and Endocrinology Center
Des Moines, Iowa, 50314
AMCR Institute
Escondido, California, 92026
Valley Research
Fresno, California, 93720
Spectrum Health System
Grand Rapids, Michigan, 49546
Physicians East, PA
Greenville, North Carolina, 27834
East Coast Institute for Research
Jacksonville, Florida, 32204
Glacier View Research Institute-Endocrinology
Kalispell, Montana, 59901
The Children's Mercy Hospital
Kansas City, Missouri, 64111
Imperial Health
Lake Charles, Louisiana, 70601
Endocrine Associates of Florida, P.A.
Lake Mary, Florida, 32746
Complete Endocrinology
Lincoln, Nebraska, 68506
Medical Investigations, Inc.
Little Rock, Arkansas, 72205
Winthrop University Hospital
Mineola, New York, 11501
International Diabetes Center
Minneapolis, Minnesota, 55416
TLC Diabetes Healthcare Consultants & Education Inc.
Naples, Florida, 34109
The Diabetes Center
Ocean Springs, Mississippi, 39564
Oregon Health & Science University
Portland, Oregon, 97239
Tri-Cities Diabetes and Endocrinology Center
Richland, Washington, 99352
Mayo Clinic
Rochester, Minnesota, 55902
Rochester General Hospital
Rochester, New York, 14621
Endocrine Research Solutions
Roswell, Georgia, 30076
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, 98521
Eastern Shore Diabetes and Endocrinology Center
Salisbury, Maryland, 21804
Endeavor Clinical Trials
San Antonio, Texas, 78229
Consano Clinical Research, LLC
San Antonio, Texas, 78258
Northeast Clinical Research of San Antonio, LLC
Schertz, Texas, 78154
Joslin Diabetes Center
Syracuse, New York, 13210
Pediatric Endocrine Associates
Tampa, Florida, 33607
Diabetes, Endocrinology, Metabolism Specialties
Teaneck, New Jersey, 07666-3445
Isaiah Pittman IV, MD
Terre Haute, Indiana, 47802
So Cal Diabetes
Torrance, California, 90505
Good Samaritan Hospital Physician Services
Vincennes, Indiana, 47591
University at Buffalo, The State University of New York
Williamsville, New York, 14221
About this study
Official title: Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data
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.
- Conditions
- Diabetes
- Being tested
- Medtronic MiniMed 530G Insulin Pump
- Keywords
- Diabetes, Insulin pump, Threshold Suspend
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic MiniMed 530G Insulin PumpDevice
| Study group | Role | What they receive |
|---|---|---|
| Medtronic MiniMed 530G Insulin Pump | Experimental | All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Receives: Device: Medtronic MiniMed 530G Insulin Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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%.
Measured: 1 year
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%
Measured: 1 year
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%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study start26 Nov 2013
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects are assigned to treatment with the Medtronic 530G Insulin Pump
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Lee, MD, Study director, Medtronic MiniMed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003898
- Sponsor's protocol ID
- CEP266
- Status last verified
- Feb 2019
- First submitted
- 25 Nov 2013
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data
- ClinicalTrials.gov ID
- NCT02003898
- Acronym / sponsor ID
- CEP266
- Conditions
- Diabetes
- Keywords
- Diabetes, Insulin pump, Threshold Suspend
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2013 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects are assigned to treatment with the Medtronic 530G Insulin Pump
| Arm | Type | Receives |
|---|---|---|
| Medtronic MiniMed 530G Insulin Pump | Experimental | Device: Medtronic MiniMed 530G Insulin PumpAll subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is age 16 or older at time of screening
- Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.
- Subject is currently on pump therapy.
- Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.
- Subject is willing to complete all study related activities
Key exclusion criteria (14 listed)
- 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.
- 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
- Subject is being treated for hyperthyroidism at time of screening
- Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic MiniMed 530G Insulin Pump | Device | Medtronic MiniMed 530G Insulin Pump |
Primary outcome
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.
3 secondary outcomes
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, Baseline A1c of 7% to 9%
Time frame: 1 year
Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Lee, MD study director
Medtronic MiniMed, Inc.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic MiniMed 530G Insulin Pump in people with Diabetes, run by Medtronic MiniMed, Inc. at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in A1C From Baseline to 1 Year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.