Type 1 DiabetesNCT02655666
Qingdao: Insulin Pump Follow-Up Program
An observational study of Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 1 site in China.
Trial summary
The purpose of the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 Pump in type 1 diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Sep 2016
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of approximately 100 subjects (age<18 years) will be enrolled by up to 10 investigational centers to complete 13 scheduled study visits in the study.
Who may be able to join
- Subject is age < 18 years at time of screening
- Subject has a clinical diagnosis of type 1 diabetes
- Subject is willing to perform required sensor calibrations
- Subject is willing to wear the Medtronic MiniMed Paradigm® REAL Time System continuously throughout the study
- Subject is a participant in the Qingdao project.
Who cannot join
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks
- Subject has known hypersensitivity to insulin or insulin infusion set(including tape)
- Subject has used the insulin pump and/or real time CGM/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting:
- For example, subjects who have used insulin pump and/or real time CGM/sensor in the inpatient setting will still be eligible for enrollment.
- For example, subjects who have used insulin pump and/or real time CGM/sensor for 8 days in the outpatient setting within 90 days before screening visit will still be eligible for enrollment.
- For example, subjects who have worn the insulin pump and/or real time CGM/sensor for 3 months in the outpatient setting a year before the screening visit will still be eligible for enrollment
Show all 11Show fewer
- 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 anti-diabetic agents.
- Subject has any systemic disease or medical condition found on screening 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.
- Subject is being treated for hyperthyroidism at time of screening
- 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
- Subject is currently abusing alcohol9. Any condition that either the Investigator believes would interfere with study participation or evaluation of results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qingdao: Insulin Pump Follow-up Program
The purpose of the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 Pump in type 1 diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China.
Read the detailed description
This is a prospective, multi-center, non-randomized and noninterventional post-market release study. Subjects will participate in 2 phases with each phase requiring the subject to use the continuous subcutaneous insulin infusion (CSII) pump over the course of the study. During the study, subjects and parent or legal guardian will be trained to wear the glucose sensor in the abdominal area for 3 days to transmit real-time (RT) data to the pump. The duration of each study phase is approximately 6 months.
- Conditions
- Type 1 Diabetes
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Medtronic MiniMed Paradigm® REAL-Time System | Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Hemoglobin (A1C)
The change of A1C from baseline to end of study (1 year) will be presented
Measured: Change in A1C from baseline to end of study (1 year)
Secondary outcomes (10)
Average Glucose Values Based on Continuous Glucose Monitoring Data
The average glucose value of all available glucose value of each subject for each evaluation period is calculated, and we present the mean and std of the individual average glucose value for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
The standard deviation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual standard deviation for each evaluation period.
Measured: Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
The coefficient of variation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual coefficient of variation for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
Mean Amplitude of Glycemic Excursion (which is often used to characterize glycemic variability, to know the detail of calculation, please refer to "Glucose Variability, © 2013 by the American Diabetes Association." ) of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Mean Amplitude of Glycemic Excursion for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Number of Events in the Hypoglycemic Range
Number of events in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Number of Events in the Hyperglycemic Range
Number of Events in the Hyperglycemic Range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Area Under Curve in the Hypoglycemic Range
Area under Curve in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Area Under Curve in the Hyperglycemic Range
Area under Curve in the hyperglycemic range (SG≥10.0 mmol/L) based on all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Percentage of Time in the Hypoglycemic Range
Percentage of time in the hypoglycemic range (SG ≤ 3.9 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percetage of time in that range for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Percentage of Time in the Hyperglycemic Range
Percentage of time in the hyperglycemic range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percentage of time in that range for each evaluation period.
Measured: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tang Li, Principal investigator, The Affiliated Hospital of Qingdao Universitychunbin Wang, Principal investigator, Chinese People's Liberation Army 401 HospitalYamie Zhu, Principal investigator, Qingdao Endocrine and Diabetes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655666
- Sponsor's protocol ID
- CEP303
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2015
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qingdao: Insulin Pump Follow-up Program
- ClinicalTrials.gov ID
- NCT02655666
- Acronym / sponsor ID
- CEP303
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Posted 21 Sep 2018
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 the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 Pump in type 1 diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China.
Detailed description
This is a prospective, multi-center, non-randomized and noninterventional post-market release study. Subjects will participate in 2 phases with each phase requiring the subject to use the continuous subcutaneous insulin infusion (CSII) pump over the course of the study. During the study, subjects and parent or legal guardian will be trained to wear the glucose sensor in the abdominal area for 3 days to transmit real-time (RT) data to the pump. The duration of each study phase is approximately 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medtronic MiniMed Paradigm® REAL-Time System | – | –Medtronic MiniMed Paradigm® REAL-Time System consisting of Paradigm 722 Insulin Pump (MMT-722), Medtronic MiniLink® REAL-Time Transmitter (MMT-7703) and Sof-Sensor® (MMT-7003) Glucose Sensor |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of approximately 100 subjects (age<18 years) will be enrolled by up to 10 investigational centers to complete 13 scheduled study visits in the study.
Key inclusion criteria (5 listed)
- Subject is age < 18 years at time of screening
- Subject has a clinical diagnosis of type 1 diabetes
- Subject is willing to perform required sensor calibrations
- Subject is willing to wear the Medtronic MiniMed Paradigm® REAL Time System continuously throughout the study
- Subject is a participant in the Qingdao project.
Key exclusion criteria (11 listed)
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks
- Subject has known hypersensitivity to insulin or insulin infusion set(including tape)
- Subject has used the insulin pump and/or real time CGM/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting:
- 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 anti-diabetic agents.
- Subject has any systemic disease or medical condition found on screening 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Glycosylated Hemoglobin (A1C)
Time frame: Change in A1C from baseline to end of study (1 year)
The change of A1C from baseline to end of study (1 year) will be presented
10 secondary outcomes
Average Glucose Values Based on Continuous Glucose Monitoring Data
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
Time frame: Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).
Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Number of Events in the Hypoglycemic Range
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Number of Events in the Hyperglycemic Range
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Area Under Curve in the Hypoglycemic Range
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Area Under Curve in the Hyperglycemic Range
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Percentage of Time in the Hypoglycemic Range
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Percentage of Time in the Hyperglycemic Range
Time frame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Tang Li principal investigator
The Affiliated Hospital of Qingdao University
chunbin Wang principal investigator
Chinese People's Liberation Army 401 Hospital
Yamie Zhu principal investigator
Qingdao Endocrine and Diabetes Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 1 site 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 21 Sep 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?
Change in Glycosylated Hemoglobin (A1C) (time frame: Change in A1C from baseline to end of study (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 11 Jul 2019.