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Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

92

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2730
        • Steno Diabetes Center Copenhagen
        • Kontakt:
        • Ledende efterforsker:
          • Mikkel Thor Olsen, MD, PhD
  • Østrig
    • Styria
      • Graz, Styria, Østrig, 8036

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: automated insulin delivery system
To date, no randomized controlled trials have evaluated inpatient use - including bolus insulin - in patients with infectious disease.
Andre navne:
  • AID
  • cloosed-loop system
Placebo komparator: 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.
Procedure: 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.
Procedure: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time in range
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time above range level 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Questionnaires
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Steno Diabetes Center Copenhagen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

15. juli 2027

Studieafslutning (Anslået)

30. juli 2027

Datoer for studieregistrering

Først indsendt

6. februar 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. oktober 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Inpatient-AID

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