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Real-world Effectiveness and Safety of Omnipod 5 in Adults With Type 1 Diabetes: a 12-month Observational Study.

8 lipca 2026 zaktualizowane przez: Giuseppe Lepore, Papa Giovanni XXIII Hospital
This retrospective observational cohort study aims to evaluate the real-world effectiveness and safety of the Omnipod® 5 Automated Insulin Delivery System in adults with type 1 diabetes receiving routine clinical care at a tertiary diabetes center. Continuous glucose monitoring metrics and glycated hemoglobin values obtained before initiation of Omnipod 5 and approximately after six, twelve and eighteen months of use will be compared to assess changes in glycemic control.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

Automated insulin delivery systems have demonstrated significant improvements in glycemic outcomes in randomized clinical trials. However, evidence from routine clinical practice remains essential to evaluate effectiveness across broader patient populations and routine care settings.

This retrospective observational cohort study will include consecutive adults with type 1 diabetes who initiated treatment with the Omnipod® 5 Automated Insulin Delivery System during routine clinical practice at ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.

Clinical and continuous glucose monitoring (CGM) data routinely collected during clinical follow-up will be extracted from medical records. Glycemic outcomes obtained before initiation of Omnipod 5 will be compared with those recorded after approximately six, twelve and eighteen months of system use.

The primary objective is to evaluate changes in Time in Range (70-180 mg/dL). Secondary objectives include assessment of HbA1c, Time Above Range, Time Below Range, glycemic variability, the proportion of participants achieving recommended international CGM targets; the prevalence of acute diabetes complications (severe hypoglycemia, diabetic ketoacidosis); and rates and causes of system dropout.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

300

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Włochy
    • Italy
      • Bergamo, Italy, Włochy, 20126
        • ASST Papa Giovanni XXIII Bergamo

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Adult individuals with type 1 diabetes treated at the Diabetes Unit of ASST Papa Giovanni XXIII Hospital who initiated Omnipod® 5 as part of routine clinical care.

Opis

Inclusion Criteria:

  • Adults aged ≥18 years
  • Diagnosis of type 1 diabetes
  • Initiation of Omnipod® 5 during routine clinical care
  • Availability of baseline CGM data
  • Availability of at least six-month follow-up CGM data

Exclusion Criteria

  • Missing baseline CGM data
  • Missing follow-up CGM data
  • Discontinuation of Omnipod® 5 before outcome assessment
  • Other conditions judged by investigators to preclude reliable evaluation

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Time in Range (70-180 mg/dL)
Ramy czasowe: Baseline, approximately 6 months. approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in Time in Range (70-180 mg/dL), defined as the percentage of time spent with glucose values within the target glucose range (70-180 mg/dL), as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
Baseline, approximately 6 months. approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in HbA1c (mmol/mol or %)
Ramy czasowe: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change in glycated hemoglobin (HbA1c) from baseline to approximately 6, 12, and 18 months after starting therapy with the Omnipod 5 system.
Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change in Time Below Range Level 1 (54-69 mg/dL)
Ramy czasowe: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in Time Below Range Level 1 (54-69 mg/dL), defined as the percentage of time spent in the glucose range 54-69 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change in Time Below Range Level 2 (<54 mg/dL)
Ramy czasowe: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in Time Below Range Level 2 (<54 mg/dL), defined as the percentage of time spent with glucose values <54 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change in Time Above Range Level 1 (>180 mg/dL)
Ramy czasowe: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in Time Above Range Level 1 (181-250 mg/dL), defined as the percentage of time spent in the glucose range181-250 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of the therapy with the Omnipod 5 system.
Baseline, approximately 6 months, approximately 12 months, and approximately 18 months Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change in Time Above Range Level 2 (>250 mg/dL)
Ramy czasowe: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in Time Above Range Level 2 (<250 mg/dL), defined as the percentage of time spent with glucose values >250 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.
Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in the number of participants experiencing at least one episode of severe hypoglycemia
Ramy czasowe: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
Change from baseline in the number of participants experiencing at least one episode of severe hypoglycemia during each follow-up period. Severe hypoglycemia is defined according to the American Diabetes Association as an event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
Change from baseline in the total number of severe hypoglycemia episodes
Ramy czasowe: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in the total number of severe hypoglycemic episodes occurring during each follow-up period. Severe hypoglycemia is defined according to the American Diabetes Association as an event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
Change from baseline in the number of participants experiencing at least one episode of diabetic ketoacidosis
Ramy czasowe: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
Change from baseline in the number of participants experiencing at least one episode of diabetic ketoacidosis during each follow-up period. Diabetic ketoacidosis will be identified according to the diagnosis documented in the medical record and standard clinical diagnostic criteria.
Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
Change from baseline in the total number of diabetic ketoacidosis episodes
Ramy czasowe: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
Change from baseline in the total number of diabetic ketoacidosis episodes occurring during each follow-up period. Diabetic ketoacidosis will be identified according to the diagnosis documented in the medical record and standard clinical diagnostic criteria.
Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Papa Giovanni XXIII Hospital

Śledczy

  • Dyrektor Studium: Nicolò Borella, MD, Endocrine Disease and Diabetes Unit, ASST Papa Giovanni XXIII Bergamo, Italy

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 stycznia 2026

Zakończenie podstawowe (Rzeczywisty)

30 czerwca 2026

Ukończenie studiów (Rzeczywisty)

30 czerwca 2026

Daty rejestracji na studia

Pierwszy przesłany

1 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 lipca 2026

Pierwszy wysłany (Rzeczywisty)

10 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Tubeless AID systems

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

No individual participant data will be shared because this is a retrospective observational study based on routinely collected clinical data. The dataset may contain potentially identifiable health information, and the informed consent/ethics approval does not specifically include permission for public sharing of individual-level data.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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