- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01137058
Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus
Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus
Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time glycemic monitoring and glucose control implemented by clinical decision support system (CDSS) using wire and wireless communication and information technology.
To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life among three study groups: control, self glucose monitoring, and U-healthcare group.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Recently, the application of internet-based glucose control system showed better long term glucose control compared to the conventional treatment. This study has become the foundation of web-based methodology in the glucose control. In addition, the combined application of mobile device and web-based monitoring system for chronic diseases showed improvement in various metabolic parameters in obese patients with diabetes and hypertension.
Thus, the application of U-healthcare based on advanced information technology would be helpful in the diabetes management. We plan to provide an individualized U-healthcare service using advanced information technology that enables more effective glucose control.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Seongnam, Korea, Republikken
- Seoul National University Bundang Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes
- age: 60 ~ 85 yrs
- HbA1c: 6.5%-11.0%
- duration of diabetes: less than 30 years
- BMI: 20-35
Exclusion Criteria:
- systemic corticosteroid administered within previous 6 months
- history of myocardial ischemia
- Heart failure, NYHA Class II-IV
- Thyroid disease with abnormal TFT
- Anti-obesity drugs or slimming products within previous 3 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: styring
konventionel behandling
|
|
Eksperimentel: U-healthcare
glucose meter and U-healthcare
|
Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.
Andre navne:
|
Aktiv komparator: SMBG group
Diabetic patients who do self monitoring of blood glucose only were categorized into self monitoring of blood glucose (SMBG) group.
|
Glucose control with self monitoring of blood glucose.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Target goal of HbA1c (< 7.0%) without hypoglycemia
Tidsramme: 24 weeks
|
Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
quality of life
Tidsramme: 24 weeks
|
24 weeks
|
|
amount of exercise
Tidsramme: 24 weeks
|
24 weeks
|
|
Body mass index (BMI) changes
Tidsramme: Body mass index
|
Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups
|
Body mass index
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Soo Lim, MD, MPH, PhD, Seoul National University Bundang Hospital
Publikationer og nyttige links
Generelle publikationer
- Lim S, Kang SM, Kim KM, Moon JH, Choi SH, Hwang H, Jung HS, Park KS, Ryu JO, Jang HC. Multifactorial intervention in diabetes care using real-time monitoring and tailored feedback in type 2 diabetes. Acta Diabetol. 2016 Apr;53(2):189-98. doi: 10.1007/s00592-015-0754-8. Epub 2015 May 5.
- Lim S, Kang SM, Shin H, Lee HJ, Won Yoon J, Yu SH, Kim SY, Yoo SY, Jung HS, Park KS, Ryu JO, Jang HC. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system. Diabetes Care. 2011 Feb;34(2):308-13. doi: 10.2337/dc10-1447.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SNUBH_UH1
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