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The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System. (CareLink)

9. juli 2013 oppdatert av: Rabin Medical Center

The Efficacy, Short and Long Term Effects of Regular Home Use Vs Diabetic Team - Supported Use of the Medtronic CareLink Therapy Management System in Patients With Diabetes

Randomized, two arms, controlled, open study comprised of two consecutive segments. At the first segment that will last during the first 4 months of the study, patients will be randomized to the Care link treated group or non Care link treated group. At this segment of the study the usage of the Care link system will be accompanied by the diabetic team, through at least monthly contact via the Internet initiated by the diabetic team. At the second segment of the study, during the following 4 months, both groups will use the Care link System, home-use, without support initiated by the diabetic team.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A randomized, two arms, controlled, open study in order to compare the efficacy, short and long term effects of regular home-use Vs diabetic team- supported use of the Medtronic CareLink therapy management system in patients with diabetes.

Primary objective:

To assess the efficacy, short term (4 months) and long term (8 months) effects of using the Medtronic CareLink® Therapy Management System for Diabetes on the following parameters:

  1. Metabolic control as expressed by HbA1c.
  2. Hypoglycemic events- number and severity of episodes.
  3. DKA and ketosis events- number and severity of episodes.
  4. Patient's satisfaction and quality of life measured by treatment satisfaction and quality of life questionnaires.
  5. 7 points glucose profile.

Secondary objective:

To compare the efficacy of 4 months treatment using the CareLink® Therapy Management System, accompanied with intensive contact (at least once a month) initiated by diabetic team via the internet/electronic mail Vs home use treatment - without monthly contact initiated by the diabetic team

Study design:

The study will be comprised of two consecutive segments. At the first segment that will last during the first 4 months of the study, patients will be randomized to the CareLink treated group or non CareLink treated group. At this segment of the study the usage of the CareLink system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. At the second segment of the study, during the following 4 months, both groups will use the CareLink system, home-use, without support initiated by the diabetic team.

Studietype

Intervensjonell

Registrering (Faktiske)

70

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

  • Israel
      • Petach-Tikva, Israel
        • Schnider children medical center

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 35 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Type 1 diabetes diagnosed at least 6 months prior to study entry
  2. Current treatment with Medtronic 722 /712 external insulin pump systems
  3. Treatment with insulin pump at least 3 month prior to study entry
  4. An internet access from patient's home
  5. Age 0-35 years old
  6. HbA1c>7.8
  7. Signing inform consent forms

Exclusion Criteria:

  1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study
  2. Patients participating in other device or drug studies

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 2
Regular treated group in the first segment and CareLink treated group in the second segment
Annen: regular home use and Medtronic CareLink Therapy Management
At the first 4 months patients will continue at their regular treatment and contacts initiated by the study team via internet/electronic mail will be made once a month. At the second segment of the study patients there will be home use of the CareLink System until the end of the study. No further contact will be initiated by the study team.
Eksperimentell: 1. CareLink team supported group
CareLink team supported group
Annen: Medtronic CareLink therapy management system
At the first segment, the usage of the CareLink system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. In the second phase of the study,during the following 4 months, there will be regular home use of the CareLink system, without support initiated by the diabetic team

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
HbA1c
Tidsramme: At Baseline and every 4 month after
At Baseline and every 4 month after

Sekundære resultatmål

Resultatmål
Tidsramme
Hypoglycemic events
Tidsramme: will be recorded through the whole study period
will be recorded through the whole study period
DKA and ketosis events
Tidsramme: will be recorded through the whole study period
will be recorded through the whole study period
Patient's satisfaction and quality of life questionnaire
Tidsramme: At baseline visit and every 4 months after
At baseline visit and every 4 months after
7 points glucose profile
Tidsramme: Will be recorded 2 days before baseline visit and every 4 months after
Will be recorded 2 days before baseline visit and every 4 months after

Samarbeidspartnere og etterforskere

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

Sponsor

Rabin Medical Center

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. januar 2009

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

23. desember 2008

Først innsendt som oppfylte QC-kriteriene

23. desember 2008

Først lagt ut (Anslag)

24. desember 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. juli 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2013

Sist bekreftet

1. juli 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • rmc005047ctil

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