Qingdao: Insulin Pump Follow-Up Program

NCT ID: NCT02655666

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-09-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tang Li

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

chunbin Wang

Role: PRINCIPAL_INVESTIGATOR

Chinese People's Liberation Army 401 Hospital

Yamie Zhu

Role: PRINCIPAL_INVESTIGATOR

Qingdao Endocrine and Diabetes Hospital

Locations

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Countries

China

Other Identifiers

CEP303

Identifier Type: -

Identifier Source: org_study_id