TerminatedNCT02655666Updated Jul 11, 2019Results posted

Qingdao: Insulin Pump Follow-Up Program

An observational study in Type 1 Diabetes, sponsored by Medtronic Diabetes. Terminated at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-07-11.

Sponsored by Medtronic Diabetes · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 16
Ages: Up to 18 Years
Sex: All

Study 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 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 studied

Type 1 Diabetes

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Diabetes Mellitus, Type 1 3,522

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.

This study's enrollment of 16 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

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Lead sponsor

Medtronic Diabetes is the lead sponsor of 61 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 21 (95%) have results posted.

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

Who can participate

Ages eligible: Up to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

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.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 16 participants (actual)
Patient registry: No

Groups and cohorts

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 researchers measure

Primary outcomes

Change in Glycosylated Hemoglobin (A1C)
The change of A1C from baseline to end of study (1 year) will be presented
Time frame: Change in A1C from baseline to end of study (1 year)

Secondary outcomes

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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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

Posted Sep 21, 2018

Participant flow

Participant flow — Overall Study
Milestone	Medtronic MiniMed Paradigm® REAL-Time System
Started	16
Completed	4
Not completed	12
Withdrew: Sponsor stopped this clinical research.	12

Outcome measures

PrimaryChange in Glycosylated Hemoglobin (A1C)

The change of A1C from baseline to end of study (1 year) will be presented

Time frame:: Change in A1C from baseline to end of study (1 year)
Reported as:: Mean · percent Glycosylated Hemoglobin

Change in Glycosylated Hemoglobin (A1C)
percent Glycosylated Hemoglobin	Medtronic MiniMed Paradigm® REAL-Time System
Change in Glycosylated Hemoglobin (A1C)	0.9 ± 2.22

SecondaryAverage 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.

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).
Reported as:: Mean · mmol/L

Average Glucose Values Based on Continuous Glucose Monitoring Data
mmol/L	Medtronic MiniMed Paradigm® REAL-Time System
Baseline	9.8 ± 2.87
Month 6	10.4 ± 3.01
Month 9	9.5 ± 2.16
Month 12	8.0 ± 0.39

SecondaryStandard 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.

Time frame:: Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).
Reported as:: Mean · mmol/L

Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
mmol/L	Medtronic MiniMed Paradigm® REAL-Time System
Baseline	3.5 ± 0.91
Month 6	3.0 ± 0.67
Month 9	3.0 ± 1.28
Month 12	2.0 ± 1.37

SecondaryCoefficient 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.

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).
Reported as:: Mean · percentage

Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
percentage	Medtronic MiniMed Paradigm® REAL-Time System
Baseline	36.3 ± 6.49
Month 6	30.5 ± 8.43
Month 9	31.0 ± 7.33
Month 12	24.3 ± 16.45

SecondaryMean 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.

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).
Reported as:: Mean · mmol/L

Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
mmol/L	Medtronic MiniMed Paradigm® REAL-Time System
Baseline	6.9 ± 2.51
Month 6	6.8 ± 1.79
Month 9	6.7 ± 3.22
Month 12	5.5 ± 0.46

SecondaryNumber 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.

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).
Reported as:: Mean · events

Number of Events in the Hypoglycemic Range
events	Medtronic MiniMed Paradigm® REAL-Time System
Baseline SG≤3.9mmol/L	0.5 ± 0.60
Month 6 SG≤3.9mmol/L	0.3 ± 0.54
Month 9 SG≤3.9mmol/L	0.1 ± 0.21
Month 12 SG≤3.9mmol/L	0.2 ± 0.17

SecondaryNumber 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.

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).
Reported as:: Mean · events

Number of Events in the Hyperglycemic Range
events	Medtronic MiniMed Paradigm® REAL-Time System
Baseline SG≥10.0 mmol/L	1.4 ± 0.73
Month 6 SG≥10.0 mmol/L	1.4 ± 0.46
Month 9 SG≥10.0 mmol/L/L	1.8 ± 0.83
Month 12 SG≥10.0 mmol/L	1.1 ± 0.92

SecondaryArea 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.

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).
Reported as:: Mean · mmol/L*min

Area Under Curve in the Hypoglycemic Range
mmol/L*min	Medtronic MiniMed Paradigm® REAL-Time System
Baseline SG≤3.9 mmol/L	0.03 ± 0.04
Month 6 SG≤3.9 mmol/L	0.01 ± 0.03
Month 9 SG≤3.9 mmol/L	0.00 ± 0.01
Month 12 SG≤3.9 mmol/L	0.00 ± 0.00

SecondaryArea 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.

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).
Reported as:: Mean · mmol/L*min

Area Under Curve in the Hyperglycemic Range
mmol/L*min	Medtronic MiniMed Paradigm® REAL-Time System
Baseline SG≥10.0 mmol/L	1.80 ± 1.55
Month 6 SG≥10.0 mmol/L	1.94 ± 1.85
Month 9 SG≥10.0 mmol/L	1.30 ± 1.36
Month 12 SG≥10.0 mmol/L	0.32 ± 0.33

SecondaryPercentage 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.

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).
Reported as:: Mean · percentage of time

Percentage of Time in the Hypoglycemic Range
percentage of time	Medtronic MiniMed Paradigm® REAL-Time System
Baseline SG ≤ 3.9 mmol/L	5.4 ± 6.87
Month 6 SG ≤ 3.9 mmol/L	1.8 ± 4.31
Month 9 SG ≤ 3.9 mmol/L	0.6 ± 1.26
Month 12 SG ≤ 3.9 mmol/L	0.6 ± 0.65

SecondaryPercentage 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.

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).
Reported as:: Mean · percentage of time

Percentage of Time in the Hyperglycemic Range
percentage of time	Medtronic MiniMed Paradigm® REAL-Time System
Baseline SG ≥ 10.0 mmol/L	44.1 ± 29.38
Month 6 SG ≥ 10.0 mmol/L	47.5 ± 32.87
Month 9 SG ≥ 10.0 mmol/L	36.6 ± 24.50
Month 12 SG ≥ 10.0 mmol/L	16.0 ± 14.77

Adverse events

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

Adverse event summary by group
Group	Deaths	Serious	Other
Medtronic MiniMed Paradigm® REAL-Time System	0/16 (0%)	2/16 (12.5%)	0/16 (0%)

Most frequent serious events

Most frequent serious events
Event	Medtronic MiniMed Paradigm® REAL-Time System
Severe HyperglycemiaMetabolism and nutrition disorders	1/16
hyperglycemiaMetabolism and nutrition disorders	1/16

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Medtronic MiniMed Paradigm® REAL-Time System
Mean	11.3 ± 2.85

Sex: Female, Male
Sex: Female, Male(Participants)	Medtronic MiniMed Paradigm® REAL-Time System
Female	11
Male	5

Region of Enrollment
Region of Enrollment(participants)	Medtronic MiniMed Paradigm® REAL-Time System
China	16

Study locations

1 site

The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02655666
Lead sponsor: Medtronic Diabetes
Responsible party: Sponsor
First posted: Jan 14, 2016
Start date: Apr 2015
Primary completion: Sep 2016
Completion: Sep 2016
Results posted: Sep 21, 2018
Last update: Jul 11, 2019

Study contacts

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

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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