Type 1 DiabetesNCT02120794
Threshold Suspend in Pediatrics at Home
A study testing 530G Insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 16 sites in United States.
Trial summary
The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- 530G Insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 16 sitesUnited States
- Study dates
- Jun 2014to 16 Jun 2017
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is age 2 to 15 at time of screening
- Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed for at least one year prior to screening
- Subject is currently transitioning from pump therapy, with or without continued glucose monitoring (CGM), to the 530G insulin pump system.
- Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
- Subject is willing to perform required sensor calibrations
- Subject is willing to wear the system (Pump, glucose sensors, meter) continuously throughout the study
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- 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 using either Humalog or Novolog at time of Screening and plans to use either of those insulins throughout the study
Who cannot join
- Subject is actively participating in an investigational study (drug or device) wherein he/she is receiving treatment from an investigational study drug or investigational study device.
- Women of child-bearing potential who have a positive pregnancy test at screening or plan 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
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- Subject is currently abusing illicit drugs
- Subject is currently abusing prescription drugs
- Subject is currently abusing alcohol
- Subject is using pramlintide (Symlin) at time of screening
- Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Subject 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
- Subject is already on a 530G system with CGM for 8 days or more.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Stony Brook Children's Hospital
East Setauket, New York, 11733
Texas Children Hospital/Baylor College of Medicine
Houston, Texas, 77030
Nemours Children's Health System
Jacksonville, Florida, 32207
The Pediatric and Endocrine Diabetes Specialists
Las Vegas, Nevada, 89148
Children's Hospital Los Angeles
Los Angeles, California, 90027
Park Nicollet Clinic - International Diabetes Center
Minneapolis, Minnesota, 55416
University of Minnesota Pediatric Endocrinology Clinic
Minneapolis, Minnesota, 55454
Yale University School of Medicine
New Haven, Connecticut, 06519
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
Sacramento, California, 95821
Children's Hospital and Clinics of Minnesota
Saint Paul, Minnesota, 55102
Madison Clinic for Pediatric Diabetes at UCSF
San Francisco, California, 94158
Stanford University
Stanford, California, 94305
SoCal Diabetes
Torrance, California, 90505
About this study
Official title: Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes
The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C.
Read the detailed description
This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1 diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the study pump.
- Conditions
- Type 1 Diabetes
- Being tested
- 530G Insulin pump
- Keywords
- Type 1 diabetes, Pediatric, Threshold Suspend, Sensor augmented pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
530G Insulin pumpDevice
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
| Study group | Role | What they receive |
|---|---|---|
| 530G insulin pump | Experimental | Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year. Receives: Device: 530G Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mean Change in A1C
The overall mean change in A1C from baseline to 1 year 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). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.
Measured: Baseline and 1 year after screening
Secondary outcomes (3)
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7%
Measured: Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9%
Measured: Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c > 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c > 9%
Measured: Baseline and 1 year after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJun 2014
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
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 Type 1 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
- single group
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Lee, M.D., Study director, Medtronic MiniMed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120794
- Sponsor's protocol ID
- CEP287
- Status last verified
- Aug 2018
- First submitted
- 21 Apr 2014
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02120794
- Acronym / sponsor ID
- CEP287
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Pediatric, Threshold Suspend, Sensor augmented pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 15 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C.
Detailed description
This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1 diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the study pump.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group
| Arm | Type | Receives |
|---|---|---|
| 530G insulin pump | Experimental | Device: 530G Insulin pumpSubjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Subject is age 2 to 15 at time of screening
- Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed for at least one year prior to screening
- Subject is currently transitioning from pump therapy, with or without continued glucose monitoring (CGM), to the 530G insulin pump system.
- Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
- Subject is willing to perform required sensor calibrations
Key exclusion criteria (16 listed)
- Subject is actively participating in an investigational study (drug or device) wherein he/she is receiving treatment from an investigational study drug or investigational study device.
- Women of child-bearing potential who have a positive pregnancy test at screening or plan 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 |
|---|---|---|
| 530G Insulin pumpSubjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year. | Device | 530G insulin pump |
Primary outcome
Overall Mean Change in A1C
Time frame: Baseline and 1 year after screening
The overall mean change in A1C from baseline to 1 year 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). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.
3 secondary outcomes
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Time frame: Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Time frame: Baseline and 1 year after screening
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Time frame: Baseline and 1 year after screening
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, M.D. study director
Medtronic MiniMed, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 530G Insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 16 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 9 inclusion and 16 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 15 Aug 2018). 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?
Overall Mean Change in A1C (time frame: Baseline and 1 year after screening). 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 11 Sep 2018.