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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Petach-Tikva, Izrael
- Schnider children medical center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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.
|
|
Eksperymentalny: 1. CareLink team supported group
CareLink team supported group
|
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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
HbA1c
Ramy czasowe: At Baseline and every 4 month after
|
At Baseline and every 4 month after
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Hypoglycemic events
Ramy czasowe: will be recorded through the whole study period
|
will be recorded through the whole study period
|
|
DKA and ketosis events
Ramy czasowe: will be recorded through the whole study period
|
will be recorded through the whole study period
|
|
Patient's satisfaction and quality of life questionnaire
Ramy czasowe: At baseline visit and every 4 months after
|
At baseline visit and every 4 months after
|
|
7 points glucose profile
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- rmc005047ctil
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .