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Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care

8. června 2026 aktualizováno: Steno Diabetes Center Copenhagen

Inpatient Diabetes Management With Automated Insulin Delivery Systems Compared to Multiple Daily Injections With a Basal-bolus Regimen - a Randomized Controlled Trial

Aim

The investigators aim to investigate if automated insulin delivery systems (AID) improve in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard-of-care with a pen-basal-bolus insulin regimen manually titrated by general staff at Herlev-Gentofte Hospital and a clinical decision support system (GlucoTab) titrating the basal-bolus regimen automatically daily at Graz University Hospital.

Population

Hospitalized patients with type 2 diabetes in non-intensive care units (non-ICU) at medical wards at Copenhagen University Hospitals of Herley-Gentofte (affiliated with Steno Diabetes Center Copenhagen) and Medical University Hospital of Graz (N = 92).

Design

This is an investigator-initiated, two-armed, two-site, prospective, randomized, open-label, blinded endpoint (PROBE) trial.

Objectives

The objective is to determine the glycemic and clinical effects of inpatient AID systems in non-ICU patients with type 2 diabetes. Participants will be randomized in a usual-of-care and an AID arm. Diabetes management will be performed by usual care in the control arm based on a basal-bolus insulin regimen and point-of-care (POC) glucose testing. A continuous glucose monitoring (CGM) system (Abbott FreeStyle Libre 3) will be used in all groups for outcome analysis and comparison between the groups. The CGM will be blinded for the control arm, to not interfere with the usual of care because of the higher amount of glucose data. The AID-arm will be managed by an AID system with real-time CGM data transmitted to nursing stations.

Outcomes

Primary outcome: The primary outcome is the difference in CGM-recorded time in range (TIR) (70-180 mg/dl (3.9-10.0 mmol/l)) between the POC- and the CGM-arm according to the 2023 in-hospital CGM consensus during the entire hospital stay.

Secondary outcomes: Outcomes are reported according to the 2023 in-hospital CGM consensus and specified in the protocol during the entire hospital stay, including three levels of time above range (TAR) 180-250mg/dl (10.0-13.9 mmol/l), >250mg/dl (>13.9 mmol/l), and >180mg/dl (>10.0 mmol/l); three levels of time below range (TBR) 54-70mg/dl (3.0-3.9 mmol/l), <54mg/dl (<3.0 mmol/l), and <70mg/dl (<3.9 mmol/l); events of hypoglycemia in three levels, 54-68mg/dl (3.0-3.8 mmol/l), <54mg/dl (< 3.0 mmol/l), and <70mg/dl (<3.9 mmol/l), where the glucose values between the two hypoglycemic events must all be >70mg/dl (>3.9 mmol/l) for at least 15 consecutive minutes(1), including prolonged hypoglycemic events (> 120 minutes), recurrent hypoglycemic events (events preceded by another hypoglycemic event), and recurrent hypoglycemic days (percentage of days with at least one hypoglycemic event on separate days that is preceded by another in-hospital day with hypoglycemia(1)); mean glucose level; standard deviation (SD) of the CGM glucose distribution; coefficient of variation (CV); and insulin doses during hospitalization.

Clinical outcomes: The investigator assess the length of hospital stay as calculated from time of admission until discharge; in-hospital mortality; admissions to intensive care unit; any in-hospital-related complications occurring at least one day after randomization and until discharge, as documented and defined by the treating physician in the electronic health record (e.g., acute kidney injurie, sepsis, etc.)

Method

For the usual-of-care-arm, glucose assessment is done by standard POC glucose testing and insulin is manually titrated by general staff at Herlev-Gentofte Hospital and the glucose assessment is done by standard POC glucose testing and insulin is manually titrated by the GlucoTab system titrating the basal-bolus regimen automatically daily at Graz University Hospital. For the AID-arm, CGM data informs in real time the mylife Ypsopump for automated insulin delivery.

Device

The investigational device is the AID system, containing of the mylife YpsoPump and the FreeStyle Libre 3 sensor.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

92

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Dánsko
      • Copenhagen, Dánsko, 2730
        • Steno Diabetes Center Copenhagen
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Mikkel Thor Olsen, MD, PhD
  • Rakousko
    • Styria
      • Graz, Styria, Rakousko, 8036
        • University Hospital of Graz
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Julia Mader, Prof. PD Dr.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • A documented history of Type 2 diabetes mellitus (T2DM) which requires subcutaneous insulin therapy
  • acute infectious disease of any kind
  • age ≥ 18 years old
  • willingness and ability to comply with theclinical investigation plan
  • ability to communicate with the trial personal
  • an expected length of hospital stay for at least 2 days after enrolment

Exclusion Criteria:

  • Patients already using AID for their glycemic management
  • Patients in use of an insulin pump
  • Skin pathologies that hinder application of a FreeStyle Libre-3 CGM and mylife YpsoPump
  • Participation in another trial, which could influence the outcome of the trial
  • Any mental condition rendering the patient incapable of giving informed consent
  • Known or suspected allergy to adhesive material/tape of the Libre-3-sensor and/or YpsoPump
  • Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient

  • Diagnoses/treatments/clinical parameters prohibiting use of Insulin/AID such as

    • Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 OR
    • Treated with hydroxyurea/hydroxycarbamide OR
    • Nutritional therapy (continuous enteral or parenteral feeding) OR
    • Clinically relevant pancreatic disease OR
    • Aystemic glucocorticoid treatment with prednisone equivalent dose >5 mg/day OR
    • Expected to require admission to the intensive-care unit OR > Patients in dialysis

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: AID-arm
In the AID-arm, participants will be equipped with a Freestyle libre-3 CGM to collect the glucose data and communicated with the mylife YpsoPump for insulin application. As part of the AID system, the participants will also be equipped with the CE-marked mylife Ypsopump to administer the needed insulin dose during the day. The insulin used for the pump for the glycaemic control of the participants will be insulin aspart.(6) The Freestyle libre-3 CGM and the YpsoPump will be coupled together in an AID system via the the mylife CamAPS HX app on a smartphone.
Přístroj: automated insulin delivery system
To date, no randomized controlled trials have evaluated inpatient use - including bolus insulin - in patients with infectious disease.
Ostatní jména:
  • AID
  • cloosed-loop system
Komparátor placeba: Control-Arm

In the control-arm, glucose levels are assessed with POC glucose testing at 03:00 h, pre-prandial at breakfast, lunch, and dinner, and before bedtime (22:00 h) or for subjects not eating at 03:00 h., 08:00 h., 12:00 h., 17:00 h., and 22:00 h as per standard of care. A blinded CGM is mounted for outcome analysis.

At admission, non-insulin antidiabetic medications will be paused, and the control-arm participants will be treated by usual-of-care with a pen based a basal-bolus regimen

Participants at Graz University Hospital are ordered the same basal-bolus insulin regimen as in the usual-of-care arm at Steno Diabetes center Copenhagen, however, insulin is not manually titrated, but titration is based daily on the GlucoTab system, a clinical decision support validated for the inpatient setting in titrating insulin for patients with type 2 diabetes as this is the usual of care at Graz University hospital.
Postup: GlucoTab
Participants at Graz University Hospital are basal-bolus insulin regimen , however, insulin is not manually titrated, but titration is based daily on the GlucoTab system, a clinical decision support validated for the inpatient setting in titrating insulin for patients with type 2 diabetes as this is the usual of care at MUG. The GlucoTab-arm will be titrated initially by the principal Investigator or sub principal investigator and afterwards by the general ward nurses of MUG.
Postup: Control-arm

In the control-arm, glucose levels are assessed with POC glucose testing at 03:00 h, pre-prandial at breakfast, lunch, and dinner, and before bedtime (22:00 h) or for participants not eating at 03:00 h, 08:00 h, 12:00 h, 17:00 h, and 22:00 h. Those collected glucose levels will be automatically transferred to the EHR. If POC glucose testing is not prescribed or performed five times daily as standard of care, the research staff may encourage usual ward nurses to do so. The investigat will also mount a FreeStyle Libre-3 CGM on each participant like descripted in the section above to be able to have a better comparison of the glucose levels throughout the day in both arms. This glucose data will be blinded and as such only be available for the diabetes research team in the end of the trial and not for the general wards.

At admission, non-insulin antidiabetic medications will be paused, and the control-arm participants will be treated by usual-of-care with a pen based a basal-bolus regimen

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time in range
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The difference in CGM-recorded time in range of 70-180 mg/dl (3.9-10.0 mmol/l) between the control-arm and the AID-arm
From inclusion in the trial until discharge from hospital (up to 30 days)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time above range level 1
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The difference in CGM-recorded time in range of 181 - 250 mg/dl (10.1 - 13.9 mmol/L) between the control-arm and the AID-arm
From inclusion in the trial until discharge from hospital (up to 30 days)
Time above range level 2
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The difference in CGM-recorded time in range of > 250 mg/dl (> 13.9 mmol/l between the control-arm and the AID-arm
From inclusion in the trial until discharge from hospital (up to 30 days)
Time below range level 1
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The difference in CGM-recorded time in the range of 54 - 70 mg/dl (3.0 - 3.9 mmol/L) between the control-arm and the AID-arm
From inclusion in the trial until discharge from hospital (up to 30 days)
Time below range level 2
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The difference in CGM-recorded time in the range of < 54 mg/dl (< 3.0 mmol/l) between the control-arm and the AID-arm
From inclusion in the trial until discharge from hospital (up to 30 days)
Hypoglycemic events level 1
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
Hypoglycemic events (defined as three consecutive CGM measures) in the range of 54-70 mg/dl (3.0-3.9 mmol/l).
From inclusion in the trial until discharge from hospital (up to 30 days)
Hypoglycemic event level 2
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
Hypoglycemic events (defined as three consecutive CGM measures) in the range of <54 mg/dl (<3.0 mmol/l).
From inclusion in the trial until discharge from hospital (up to 30 days)
Recurrent hypoglycemic event
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
Recurrent hypoglycemic events, defined as events preceded by another hypoglycemic event. The glucose values between the two episodes must all be > 70mg/dl (>3.9 mmol/l) for at least 15 consecutive minutes between the sentinel and recurrent hypoglycemic events to count.
From inclusion in the trial until discharge from hospital (up to 30 days)
Time at High Risk for Hypoglycemia
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The difference in CGM-recorded time in range of 70 - 100 mg/dl (3.9 - 5.6 mmol/l) between the control-arm and the AID-arm
From inclusion in the trial until discharge from hospital (up to 30 days)
Glycemia risk index
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
Defined by the formula [3.0 × % time below 54mg/dl (3.0 mmol/l)] +[2.4 × % time below 70mg/dl (3.9 mmol/l)] + [1.6 × % time above 180mg/dl (10.0 mmol/l)] + [0.8 × % time above 250mg/dl (13.9 mmol/l)].
From inclusion in the trial until discharge from hospital (up to 30 days)
Prolonged hypoglycemic events level 1
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
A hypoglycaemic event 54 - 70 mg/dl (3.0 - 3.9 mmol/l) continuously for at least 120 minutes.
From inclusion in the trial until discharge from hospital (up to 30 days)
Prolonged hypoglycemic event level 2
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
A hypoglycaemic event <54 mg/dl (<3.0 mmol/l) continuously for at least 120 minutes.
From inclusion in the trial until discharge from hospital (up to 30 days)
Severe hypoglycemia
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
Patient requires assistance to correct hypoglycemia.
From inclusion in the trial until discharge from hospital (up to 30 days)
Mean sensor glucose
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
Mean sensor glucose from the CGM in mg/dl (mmol/l).
From inclusion in the trial until discharge from hospital (up to 30 days)
Standard deviation of the glucose distribution
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The standard deviation mg/dl (mmol/l) from the CGM glucose measurements.
From inclusion in the trial until discharge from hospital (up to 30 days)
Coefficient of variation
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The standard deviation of the glucose distribution divided by the mean glucose level.
From inclusion in the trial until discharge from hospital (up to 30 days)
Length of stay
Časové okno: From admission untill discharge from the hospital (up to 30 days)
The amount of time spent in the hospital from admission untill discharge from the hospital
From admission untill discharge from the hospital (up to 30 days)
In-hospital complications
Časové okno: One day after randomisation until discharge from the hospital (up to 30 days)
Any in-hospital related complications occurring at least one day after randomization (e.g. acute kidney injury, sepsis, etc.)
One day after randomisation until discharge from the hospital (up to 30 days)
Total daily insulin doses
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The amoun of daily insulin given.
From inclusion in the trial until discharge from hospital (up to 30 days)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Questionnaires
Časové okno: From inclusion in the trial until discharge from hospital (up to 30 days)
The validated Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP) will be used. The questionnaires will assess the patient satisfaction level and staff satisfaction level in managing patients on either control-arm patients vs AID systems. Exploratory, the investigators will identify which patients might benefit from AID and in-hospital diabetes teams by heterogeneity of treatment effect analyses.
From inclusion in the trial until discharge from hospital (up to 30 days)
Time management
Časové okno: From inclusion until discharge from hospital (up to 30 days)
Time management for setting up the AID system and maintaining it is compared to usual-of-care (time spent monitoring POC glucose testing and administering basal-bolus regimen insulin daily).
From inclusion until discharge from hospital (up to 30 days)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Steno Diabetes Center Copenhagen

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

15. července 2027

Dokončení studie (Odhadovaný)

30. července 2027

Termíny zápisu do studia

První předloženo

6. února 2026

První předloženo, které splnilo kritéria kontroly kvality

8. června 2026

První zveřejněno (Aktuální)

12. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. června 2026

Naposledy ověřeno

1. října 2025

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Inpatient-AID

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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