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Qingdao: Insulin Pump Follow-Up Program

19 april 2019 uppdaterad av: Medtronic Diabetes

Qingdao: Insulin Pump Follow-up Program

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

16

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Shandong
      • Qingdao, Shandong, Kina
        • The Affiliated Hospital Of Qingdao University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Glycosylated Hemoglobin (A1C)
Tidsram: 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
Change in A1C from baseline to end of study (1 year)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average Glucose Values Based on Continuous Glucose Monitoring Data
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medtronic Diabetes

Utredare

  • Huvudutredare: Tang Li, The Affiliated Hospital Of Qingdao University
  • Huvudutredare: chunbin Wang, Chinese People's Liberation Army 401 Hospital
  • Huvudutredare: Yamie Zhu, Qingdao Endocrine and Diabetes Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2015

Primärt slutförande (Faktisk)

1 september 2016

Avslutad studie (Faktisk)

1 september 2016

Studieregistreringsdatum

Först inskickad

18 december 2015

Först inskickad som uppfyllde QC-kriterierna

12 januari 2016

Första postat (Uppskatta)

14 januari 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 juli 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 april 2019

Senast verifierad

1 april 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CEP303

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

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