Evaluering af effektiviteten og livskvalitetens indvirkning af overgang til avanceret hybrid lukket sløjfe insulinpumpeterapi hos rumænske børn med type 1 diabetes mellitus
The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).
Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Sector 1
-
Bucharest, Sector 1, Rumænien, 011461
- Elias University Emergency Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 7 years or older at baseline
- Diagnosis of type 1 diabetes
- Current use of a predictive low glucose suspend insulin pump (740G)
- At least 30% of subjects must have an HbA1c > 7,5% (58 mmol/mol)
Exclusion Criteria:
- Age < 7 years or ≥ 18 years at baseline
- Diabetes duration < 1 year at baseline
- HbA1c ≤ 7% (53 mmol/mol)
- Not meeting the Romanian national standards for closed-loop insulin pump therapy
- Other criteria deemed inappropriate by the principal investigator (to be documented)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 780G
Patients in this arm will receive a 780G for three months. |
Patients using a Medtronic 740G insulin pump will receive the 780G model for three months |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Variations in HbA1c
Tidsramme: Three months
|
Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
changes in insulin requirements
Tidsramme: Three months
|
changes in insulin requirements between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in time in range (TIR) levels
Tidsramme: Three months
|
changes in time in range (TIR) levels between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in time below range (TBR)
Tidsramme: Three months
|
changes in time below range (TBR) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in coefficient of variation (CV)
Tidsramme: Three months
|
changes in coefficient of variation (CV) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization
Tidsramme: Three months
|
changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G) |
Three months
|
|
changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores
Tidsramme: Three months
|
changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Scores are transformed on a scale from 0 to 100. Higher scores = Better Quality of Life |
Three months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 105122023-1/05.12.2023
- ERP-2023-13520 (Andet bevillings-/finansieringsnummer: Medtronic)
Plan for individuelle deltagerdata (IPD)
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