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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 35 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 2
Regular treated group in the first segment and CareLink treated group in the second segment
Andet: 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.
Eksperimentel: 1. CareLink team supported group
CareLink team supported group
Andet: 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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rabin Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2009

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

23. december 2008

Først indsendt, der opfyldte QC-kriterier

23. december 2008

Først opslået (Skøn)

24. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • rmc005047ctil

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med regular home use and Medtronic CareLink Therapy Management

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    Moderat aortaklapstenose
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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner