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Trial record 3 of 4 for:    "MiniMed Paradigm REAL-Time System"

Qingdao: Insulin Pump Follow-Up Program

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ClinicalTrials.gov Identifier: NCT02655666
Recruitment Status : Terminated
First Posted : January 14, 2016
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
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.

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. Standard Deviation Based on Continuous Glucose Monitoring Data [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate the Standard Deviation based on Continuous Glucose Monitoring data every 3 month until end of study (1 year).

  2. Coefficient of Variation Based on Continuous Glucose Monitoring Data [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate the Coefficient of Variation based on Continuous Glucose Monitoring data every 3 month until end of study (1 year).

  3. Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate Mean Amplitude of Glycemic Excursion based on Continuous Glucose Monitoring data every 3 month until end of study (1 year).

  4. Number of Events in the Hypoglycemic Range [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate number of Events in the hypoglycemic range (Sensor Glucose (SG) ≤ 2.2, 2.8, 3.3, 3.6, and 3.9 mmol/L) every 3 month until end of study (1 year).

  5. Number of Events in the Hyperglycemic Range [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate number of events in hypoglycemic range (SG ≥ 10.0, 13.9, 16.7, 19.4, and 22.2 mmol/L) every 3 month until end of study (1 year).

  6. Area Under Curve in the Hypoglycemic Range [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate area under Curve in the hypoglycemic range (Sensor Glucose (SG) ≤ 2.2, 2.8, 3.3, 3.6, and 3.9 mmol/L) every 3 month until end of study (1 year).

  7. Area Under Curve in the Hyperglycemic Range [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate area under Curve in the hyperglycemic range (SG ≥ 10.0, 13.9, 16.7, 19.4, and 22.2 mmol/L) every 3 month until end of study (1 year).

  8. Time Spent in the Hypoglycemic Range [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    calculate time Spent in the hypoglycemic range (SG ≤ 2.2, 2.8, 3.3, 3.6, and 3.9 mmol/L) every 3 month until end of study (1 year).

  9. Time Spent in the Hyperglycemic Range [ Time Frame: Calculated every 3 month until end of study (1 year) ]
    Calculate time spent in hyperglycemic range (SG ≥ 10.0, 13.9, 16.7, 19.4, and 22.2 mmol/L) every 3 month until end of study (1 year).



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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
China, Shandong
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Sponsors and Collaborators
Medtronic Diabetes
Investigators
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

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02655666     History of Changes
Other Study ID Numbers: CEP303
First Posted: January 14, 2016    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: September 21, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs