Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Qingdao: Insulin Pump Follow-Up Program

19. april 2019 oppdatert 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.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

16

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Glycosylated Hemoglobin (A1C)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Average Glucose Values Based on Continuous Glucose Monitoring Data
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medtronic Diabetes

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2015

Primær fullføring (Faktiske)

1. september 2016

Studiet fullført (Faktiske)

1. september 2016

Datoer for studieregistrering

Først innsendt

18. desember 2015

Først innsendt som oppfylte QC-kriteriene

12. januar 2016

Først lagt ut (Anslag)

14. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CEP303

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Type 1 diabetes

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Georgia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere