Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    "MiniMed Paradigm REAL-Time System"

Qingdao: Insulin Pump Follow-Up Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655666
Recruitment Status : Terminated
First Posted : January 14, 2016
Results First Posted : September 21, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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.

Condition or disease
Type 1 Diabetes

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qingdao: Insulin Pump Follow-up Program
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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). ]
    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.

  2. 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.). ]
    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.

  3. 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). ]
    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.

  4. 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). ]
    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.

  5. 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 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.

  6. 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). ]
    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.

  7. 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 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.

  8. 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). ]
    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.

  9. 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 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.

  10. 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). ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655666


Locations
Layout table for location information
China, Shandong
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Layout table for investigator information
Principal Investigator: Tang Li The Affiliated Hospital of Qingdao University
Principal Investigator: chunbin Wang Chinese People's Liberation Army 401 Hospital
Principal Investigator: Yamie Zhu Qingdao Endocrine and Diabetes Hospital
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02655666    
Other Study ID Numbers: CEP303
First Posted: January 14, 2016    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: July 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases