- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03047486
Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes (Smartguard)
The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.
The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Caen, Frankrike, 14000
- Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Type 1 diabetes ≥ 1 year
- CSII ≥ 6 months
- Previous education to flexible insulin therapy
- Patient willing to use sensors and smartguard option for 1 year
- A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes
Exclusion Criteria:
- No access to a computer and/or to the web making it impossible to follow patients through telemedicine
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Glucose TIR (time in range) from CGM recording
Tidsramme: change between baseline and after 12 month
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TIR will be calculated from the CGM recording, thanks to the medtronic carelink software
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change between baseline and after 12 month
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Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording
Tidsramme: change between baseline and after 12 month
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Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software
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change between baseline and after 12 month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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HbA1c
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Andre resultatmål
Resultatmål |
Tidsramme |
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daily insulin total dose
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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basal / bolus ratio
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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daily bolus number
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Mean daily hypoglycemic predictive-stop time
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Mean daily hypoglycemic-stop time
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Time Percentage with CGM Sensor Use Time
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Medical time at each consultation
Tidsramme: month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael JOUBERT, MD, University Hospital, Caen
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 16-106
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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Kliniske studier på Type 1 diabetes mellitus begynner å modne
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McGill University Health Centre/Research Institute...RekrutteringDiabetes mellitus, type 1 | Wolfram syndrom | Neonatal diabetes | Monogen diabetes | Maturity-debut diabetes in the Young (MODY) | Wolcott-Rallison syndrom | Mitokondriell diabetesCanada