- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00598663
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c (SWITCH)
Randomized, Cross Over, Controlled, Multi-centric Study to Assess Whether Type 1 Diabetic Patients in Sub-optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Paradigm Insulin Pump
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Copenhagen, Danmark
- Steno Diabetes center
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Glostrup, Danmark
- Glostrup Hospital
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Rome, Italia
- Clinica Pediatrica, Policlinico Umberto I
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Luxembourg, Luxembourg
- Center Hospitalier de Luxembourg
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Gouda, Nederland
- Groene Hart Ziekenhuis
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Ljubljana, Slovenia
- University Children's Hospital
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Barcelona, Spania
- Hospital Clinic i Universitari
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Vienna, Østerrike
- Hospital Hietzing
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
- Sub-optimal glycemic control (7.5%<HbA1c<9.5%).
- Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
- Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
- Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.
Exclusion Criteria:
- Existing pregnancy or intention to conceive (as assessed by investigator).
- Hearing or vision impairment so that glucose display and alarms cannot be recognized.
- Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
- History of hypoglycemic unawareness as assessed by the investigator.
- Alcohol or drug abuse, other than nicotine.
- Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
- Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index >35 and children Body Mass Index > 2 standard deviations. for age) as assessed by the investigator.
- Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
- For pediatric subjects: does not have a reliable support person.
- Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
- Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Off/On
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] 4 month wash out period 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] |
6 months of pump plus continuous glucose sensing in conjunction to SMBG
Andre navn:
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Eksperimentell: On/Off
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously] 4 month wash out period 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature] |
insulin pump with smbg to be worn for 6 months.
15 days in each 6 week period blinded continuous glucose sensing will be conducted.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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HbA1c at 6 Month
Tidsramme: 6 months
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The end of period difference in HbA1c after 6 months of treatment
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Glycemic Variability
Tidsramme: 6 months
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24 h SD of glucose values (mg/dl)
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6 months
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Number of Severe Hypoglycemia Events
Tidsramme: 6 months
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6 months
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Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
Tidsramme: 6 months
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6 months
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Postprandial Glycaemia
Tidsramme: 6 months
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Breakfast Postprandial glycaemia
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6 months
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Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
Tidsramme: 6 months
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This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998). Scores are transformed on a scale from 0 to 100. higher values represent a better outcome |
6 months
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Diabetic Ketoacidosis Events
Tidsramme: 6 months
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A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose >250 mg/dL) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Dr. T Battelino, University Children's Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EUR03
- ISRCTN09806152
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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