Qingdao: Insulin Pump Follow-Up Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Qingdao: Insulin Pump Follow-up Program

Conditions
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Type 1 Diabetes

Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medtronic MiniMed Paradigm® REAL-Time System<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Hemoglobin (A1C) | The change of A1C from baseline to end of study (1 year) will be presented | Change in A1C from baseline to end of study (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected). |