- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01044368
Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus (DM) on Monotherapy
Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus on Monotherapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Purpose: To determine whether use of an Internet-based glucose monitoring system (ALR Technologies Inc.) improves Hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus treated with only 1 oral anti-diabetic medication.
Hypothesis: The investigators propose that the standardized encounters using the Internet will improve the outcome of treatment for patients with type 2 DM.
Justification: An important aspect of diabetes care is the self-monitoring of blood glucose (SMBG) levels in order to assess the effectiveness of treatment and to modify the treatment to achieve the desirable glucose levels. All patients with type 2 DM are recommended to perform SMBG. However, it often requires intervention by health professionals in order to prevent the immediate and serious complications of hyper or hypoglycemia. The frequent SMBG and effective interventions by the health professionals may eventually allow tighter control of blood glucose levels and delay or prevent the complications associated with diabetes.
Objectives: The investigators propose to measure HbA1c levels at the beginning of the study and compare this with HbA1c levels at three and six months after initiating Internet-based blood glucose monitoring system (IBMS).
Research Method: Fifty patients will be randomized equally (a 50/50 chance) to either conventional therapy or the use of the Internet blood glucose monitoring system.
Conventional therapy (Control group) will consist of general care comprising of SMBG 3 or more times per day and visits to the endocrinologist at 3-month intervals with HbA1c, cholesterols, and serum creatinine determinations at 3-month intervals for 6 months.
Those patients randomized to the Internet system (Intervention group) will be required to perform SMBG 3 or more times per day and to upload their metered glucose values online every 2 weeks to be reviewed by the doctor. As well, there will be visits to the endocrinologist every 3 months with HbA1c, cholesterols, and serum creatinine measurements at 3-month intervals for 6 months.
Statistical Analysis: The primary endpoint is the HbA1c level or the change in A1c level. The secondary endpoints include severe hypoglycemia defined as requiring external aid, hospital admissions for any CVD related intervention, and adverse events such as unplanned hospitalizations for any cause that last more than 24 hours. For each group, A1C levels before the start of study will be compared to A1C levels 3 and 6 months after the start of the study. Paired t-tests and random effects models (longitudinal analyses) will examine differences in A1C values before and after the study duration. Unpaired, independent t-tests will be done to examine the difference in A1C values between the two groups before and after the interventions. Planned sample size is 50.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes patients treated with only 1 oral anti-diabetic medication
- A1C 7-11%
- >25 years of age
- Willingness to test blood glucose levels a minimum of 3 times daily
- Willingness to be randomized
- Trained in self blood glucose monitoring
- Internet Access
Exclusion Criteria:
- Patients who do not meet the inclusion criteria or are not willing to participate will not be included in the study.
- In addition patients with the potential to become pregnant or patients using medications known to influence control of diabetes (eg steroids systemic or inhaled) are excluded from the study.
Studieplan
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 |
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Eksperimentel: Internetintervention
De forsøgspersoner, der er tilmeldt Internet Therapeutic Intervention-armen, modtager standardbehandling ved at teste deres blodsukker mindst 3 gange dagligt og besøge endokrinologen hver 3. måned; de bliver dog også bedt om at uploade deres blodsukkermålinger online hver anden uge, så lægen kan se og kommentere.
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De forsøgspersoner, der er tilmeldt Internet Therapeutic Intervention-armen, modtager standardbehandling ved at teste deres blodsukker mindst 3 gange dagligt og besøge endokrinologen hver 3. måned; de bliver dog også bedt om at uploade deres blodsukkermålinger online hver anden uge, så lægen kan se og kommentere.
Andre navne:
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Ingen indgriben: Standardpleje
Denne arm vil modtage standardbehandling, som inkluderer selvblodsukkermonitorering mindst 3 gange dagligt og besøg hos endokrinologen mindst en gang hver 3. måned.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Det primære endepunkt er A1c-niveauet eller ændringen i A1c-niveau
Tidsramme: 6 måneder
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6 måneder
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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De sekundære endepunkter omfatter alvorlig hypoglykæmi defineret som at kræve ekstern hjælp, hospitalsindlæggelser for enhver CVD-relateret intervention og uønskede hændelser såsom uplanlagte hospitalsindlæggelser af enhver årsag, der varer mere end 24 timer
Tidsramme: 6 måneder
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6 måneder
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Hugh D Tildesley, MD, Providence Health Care, University of British Columbia
Publikationer og nyttige links
Generelle publikationer
- Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.
- Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.
- Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
- Klonoff DC, Bergenstal R, Blonde L, Boren SA, Church TS, Gaffaney J, Jovanovic L, Kendall DM, Kollman C, Kovatchev BP, Leippert C, Owens DR, Polonsky WH, Reach G, Renard E, Riddell MC, Rubin RR, Schnell O, Siminiero LM, Vigersky RA, Wilson DM, Wollitzer AO. Consensus report of the coalition for clinical research-self-monitoring of blood glucose. J Diabetes Sci Technol. 2008 Nov;2(6):1030-53. doi: 10.1177/193229680800200612.
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- T2D Monotherapy-Internet BGM
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