Easy Diabetes Treatment Study 1 (EASY-1)
A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Halland, Sverige
- Region Halland
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Skåne, Sverige
- Region Skane
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Västra Götaland, Sverige
- Västra Götalandsregionen
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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:
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- ≥ 18 years of age at the time of signing informed consent
- Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening
- HbA1c ≥ 7.0 [58 mmol/mol] by central laboratory analysis
- Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)
Exclusion Criteria:
- Previous participation in this trial. Participation is defined as informed consent.
- Currently participating in other clinical trials for diabetes
- Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
- Corticosteroid-induced or pancreatitis-induced diabetes
- History of chronic or acute pancreatitis
- Known or suspected substance abuse
- Pregnancy
- Anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins)
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
- Renal failure stage 5, defined as (estimated or exact) glomerular filtration rate < 15 mL/min/1.73m2
- Recent or planned major surgery (such as gastric bypass operation)
- Major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel
- Life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Standard of Care with DSS
Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients. Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
|
Aktiv komparator: Standard of Care without DSS
Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c
Tidsramme: 26 weeks
|
Change from baseline HbA1c
|
26 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fasting plasma glucose
Tidsramme: 26 weeks
|
Change from baseline in fasting plasma glucose (FPG)
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26 weeks
|
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Achieving treatment target
Tidsramme: 26 weeks
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Meeting treatment target of HbA1c < 7% (53 mmol/mol)
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26 weeks
|
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Hypoglycemia
Tidsramme: 26 weeks
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Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes
|
26 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Damon Tojjar, MD, Lund University
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 (Faktiske)
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
- EASY-1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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