Type 2 DiabetesNCT01921322
Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy
A study testing Pump and CGMS Gold in people with Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 2 sites in China.
Trial summary
This is a prospective, randomized (open label), multi-center and post-market study. The study is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in China Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pump and CGMS Gold
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2013to May 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 to 65 years old at time of screening
- A clinical diagnosis of type 2 diabetes > 6 months prior to the screening as determined by the Investigator,
- Treating with insulin at least one injection per day prior to participate in the study
- Glycosylated hemoglobin (A1C) > 8% at screening
- Subject needs to be hospitalized to receive treatment for glucose management according to Endocrinologists' discretion
- Subject is willing to follow protocol and underdo all study procedures
- Subject is willing and able to provide informed written consent personally or by legal proxy
Who cannot join
- Subject has known hypersensitivity to insulin or insulin infusion set
- Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral agents.
- random blood glucose is above 33 mmol/L
- Subject is currently using real time CGM therapy prior to screening
- Subject is currently using insulin pump therapy prior to screening
- Female subject who is pregnant, or plans to become pregnant during the course of the study
Show all 14Show fewer
- Patients who are critically ill that must go to intensive critical care unit per Investigator discretion
- Subject has any systemic disease or medical condition found on the screening tests that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study. The following includes, but not limited to, those conditions:
- Female subject has a positive serum pregnancy screening test
- Subject has visually impaired or disability limits the use of RT-CGM.
- Subject has any unresolved adverse skin condition in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject has disease with a known effect on BG such as Active Graves' disease
- Subject has a history of alcohol abuse
- Any other condition, which may not be suitable for the study at physician's discretion.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chinese PLA General Hospital
Beijing
The Second Hospital of Jilin University
Changchun, Jilin
About this study
Official title: Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target
This is a prospective, randomized (open label), multi-center and post-market study. The study is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in China
Read the detailed description
Primary objective:
To compare the length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus MDI
Secondary Objectives:
To compare glycemic variability (using CGM as reference method) with the 722 Paradigm Real-Time insulin pump versus MDI
This is a prospective, randomized (open label), multi-center study. The clinical study staff will conduct screening tests according to inclusion/exclusion criteria in order to verify the subject's eligibility for the study.
Inpatient Period A patient is admitted into hospital for treatment of diabetes
Randomization
Subjects are randomized (at a 1:1 ratio) to group A or B in the study database. A total of 80 subjects will be randomized into 2 study groups:
- Group A will wear 722 Paradigm Real-Time System (treated with 24h per day insulin infusion)
- Group B will be on MDI and wear the CGMS-Gold (treated with 4 insulin injections).
It is anticipated that the total duration for the study will be within one year from site initiation to finalization of all data entry and monitoring.
Each subject will participate in the study approximately 2 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- Pump, CGMS Gold
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumpDevice
722 Paradigm Real-Time System
CGMS GoldOther
Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Pump | Experimental | Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring Receives: Device: Pump |
| MDI | Active comparator | Multiple daily insulin injections used for treatment Receives: Other: CGMS Gold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Target
length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection
Measured: Up to 14 days in hospital
Secondary outcomes (1)
Glycemic Variability
Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method
Measured: Up to 14 days in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
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 2 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomly assigned to undergo treatment using either the Paradigm 722 insulin pump or multiple daily insulin injections.
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921322
- Sponsor's protocol ID
- CEP270
- Status last verified
- Jun 2017
- First submitted
- 9 Aug 2013
- Last updated
- 6 Jul 2017
- 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 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target
- ClinicalTrials.gov ID
- NCT01921322
- Acronym / sponsor ID
- CEP270
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Posted 6 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized (open label), multi-center and post-market study. The study is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in China
Detailed description
Primary objective:
To compare the length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus MDI
Secondary Objectives:
To compare glycemic variability (using CGM as reference method) with the 722 Paradigm Real-Time insulin pump versus MDI
This is a prospective, randomized (open label), multi-center study. The clinical study staff will conduct screening tests according to inclusion/exclusion criteria in order to verify the subject's eligibility for the study.
Inpatient Period A patient is admitted into hospital for treatment of diabetes
Randomization
Subjects are randomized (at a 1:1 ratio) to group A or B in the study database. A total of 80 subjects will be randomized into 2 study groups:
- Group A will wear 722 Paradigm Real-Time System (treated with 24h per day insulin infusion)
- Group B will be on MDI and wear the CGMS-Gold (treated with 4 insulin injections).
It is anticipated that the total duration for the study will be within one year from site initiation to finalization of all data entry and monitoring.
Each subject will participate in the study approximately 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects randomly assigned to undergo treatment using either the Paradigm 722 insulin pump or multiple daily insulin injections.
| Arm | Type | Receives |
|---|---|---|
| Pump | Experimental | Device: PumpParadigm 722 insulin pump used for insulin infusion and continuous glucose monitoring |
| MDI | Active comparator | Other: CGMS GoldMultiple daily insulin injections used for treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18 to 65 years old at time of screening
- A clinical diagnosis of type 2 diabetes > 6 months prior to the screening as determined by the Investigator,
- Treating with insulin at least one injection per day prior to participate in the study
- Glycosylated hemoglobin (A1C) > 8% at screening
- Subject needs to be hospitalized to receive treatment for glucose management according to Endocrinologists' discretion
Key exclusion criteria (14 listed)
- Subject has known hypersensitivity to insulin or insulin infusion set
- Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral agents.
- random blood glucose is above 33 mmol/L
- Subject is currently using real time CGM therapy prior to screening
- Subject is currently using insulin pump therapy prior to screening
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 |
|---|---|---|
| Pump722 Paradigm Real-Time System | Device | Pump |
| CGMS GoldDevice used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm | Other | MDI |
Primary outcome
Time to Target
Time frame: Up to 14 days in hospital
length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection
1 secondary outcome
Glycemic Variability
Time frame: Up to 14 days in hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pump and CGMS Gold in people with Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 2 sites in China.
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 7 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 6 Jul 2017). 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?
Time to Target (time frame: Up to 14 days in hospital). 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 6 Jul 2017.