Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

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

2026. július 8. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

300

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Time in Range (70-180 mg/dL)
Időkeret: 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.

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in HbA1c (mmol/mol or %)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Papa Giovanni XXIII Hospital

Nyomozók

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

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. január 7.

Elsődleges befejezés (Tényleges)

2026. június 30.

A tanulmány befejezése (Tényleges)

2026. június 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 1.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 8.

Első közzététel (Tényleges)

2026. július 10.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. július 10.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 8.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • Tubeless AID systems

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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.

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Iratkozz fel