The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System. (CareLink)
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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:
- Metabolic control as expressed by HbA1c.
- Hypoglycemic events- number and severity of episodes.
- DKA and ketosis events- number and severity of episodes.
- Patient's satisfaction and quality of life measured by treatment satisfaction and quality of life questionnaires.
- 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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Petach-Tikva, Israël
- Schnider children medical center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Type 1 diabetes diagnosed at least 6 months prior to study entry
- Current treatment with Medtronic 722 /712 external insulin pump systems
- Treatment with insulin pump at least 3 month prior to study entry
- An internet access from patient's home
- Age 0-35 years old
- HbA1c>7.8
- Signing inform consent forms
Exclusion Criteria:
- 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
- Patients participating in other device or drug studies
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 2
Regular treated group in the first segment and CareLink treated group in the second segment
|
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.
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Expérimental: 1. CareLink team supported group
CareLink team supported group
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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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
HbA1c
Délai: At Baseline and every 4 month after
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At Baseline and every 4 month after
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Hypoglycemic events
Délai: will be recorded through the whole study period
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will be recorded through the whole study period
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DKA and ketosis events
Délai: will be recorded through the whole study period
|
will be recorded through the whole study period
|
|
Patient's satisfaction and quality of life questionnaire
Délai: At baseline visit and every 4 months after
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At baseline visit and every 4 months after
|
|
7 points glucose profile
Délai: Will be recorded 2 days before baseline visit and every 4 months after
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Will be recorded 2 days before baseline visit and every 4 months after
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- rmc005047ctil
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