Clinical trial NCT02655666: Qingdao: Insulin Pump Follow-Up Program
Official title: Qingdao: Insulin Pump Follow-up Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2016-01-14
Enrollment: 16
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (A1C)
timeFrame: Change in A1C from baseline to end of study (1 year)
Secondary outcomes:
measure: Average Glucose Values Based on Continuous Glucose Monitoring Data
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data
timeFrame: Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).
measure: Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Number of Events in the Hypoglycemic Range
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Number of Events in the Hyperglycemic Range
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Area Under Curve in the Hypoglycemic Range
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Area Under Curve in the Hyperglycemic Range
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Percentage of Time in the Hypoglycemic Range
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
measure: Percentage of Time in the Hyperglycemic Range
timeFrame: Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Tang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese People's Liberation Army 401 Hospital
name: chunbin Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Endocrine and Diabetes Hospital
name: Yamie Zhu
role: PRINCIPAL_INVESTIGATOR
References: