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Diabetes Mellitus Type 2NCT07645079

Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care

A study testing automated insulin delivery system and GlucoTab in people with Diabetes Mellitus Type 2 and Infection, run by Steno Diabetes Center Copenhagen at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2, Infection, CGM
What is being tested?
automated insulin delivery system and GlucoTab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
2 sitesin 2 countries
Study dates
1 Jul 2026to 30 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

2 sites in 2 countries

Austria1 site

  • University Hospital of Graz

    Graz, Styria, 8036

    Julia Mader, Prof. PD Dr., +43 318 385 80254, julia.mader@medunigraz.at

    Paul Klopf, +4331638526176, paul.klopf@stud.medunigraz.at

Other trials in Austria

Denmark1 site

  • Steno Diabetes Center Copenhagen

    Copenhagen, 2730

    Mikkel Thor Olsen, MD, PhD, +45 31 49 72 95, mikkel.thor.olsen@regionh.dk

    Mikkel Thor Olsen, MD, PhD

Other trials in Denmark

About this study

Official title: 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.

Read more

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.

Being tested
automated insulin delivery system, GlucoTab, Control-arm
Keywords
automated insulin delivery systems, AID, CGM, continouse glucose monitoring, infectiouse disease, type 2 diabetes mellitus, diabetes mellitus type 2, GlucoTab
Medical subject headings
Diabetes Mellitus, Type 2, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • automated insulin delivery systemDevice

    Also called AID, cloosed-loop system

    To date, no randomized controlled trials have evaluated inpatient use - including bolus insulin - in patients with infectious disease.

  • GlucoTabProcedure or surgery

    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.

  • Control-armProcedure or surgery

    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

Study groups in NCT07645079
Study groupRoleWhat they receive
AID-armExperimentalIn 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.
Receives: Device: automated insulin delivery system
Control-ArmPlacebo comparatorIn 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.
Receives: Procedure: GlucoTab; Procedure: Control-arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in range

    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

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

Secondary outcomes (18)

  1. Time above range level 1

    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

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  2. Time above range level 2

    The difference in CGM-recorded time in range of > 250 mg/dl (> 13.9 mmol/l between the control-arm and the AID-arm

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  3. Time below range level 1

    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

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  4. Time below range level 2

    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

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  5. Hypoglycemic events level 1

    Hypoglycemic events (defined as three consecutive CGM measures) in the range of 54-70 mg/dl (3.0-3.9 mmol/l).

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  6. Hypoglycemic event level 2

    Hypoglycemic events (defined as three consecutive CGM measures) in the range of <54 mg/dl (<3.0 mmol/l).

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  7. Recurrent hypoglycemic event

    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.

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  8. Time at High Risk for Hypoglycemia

    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

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  9. Glycemia risk index

    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)].

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  10. Prolonged hypoglycemic events level 1

    A hypoglycaemic event 54 - 70 mg/dl (3.0 - 3.9 mmol/l) continuously for at least 120 minutes.

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  11. Prolonged hypoglycemic event level 2

    A hypoglycaemic event <54 mg/dl (<3.0 mmol/l) continuously for at least 120 minutes.

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  12. Severe hypoglycemia

    Patient requires assistance to correct hypoglycemia.

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  13. Mean sensor glucose

    Mean sensor glucose from the CGM in mg/dl (mmol/l).

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  14. Standard deviation of the glucose distribution

    The standard deviation mg/dl (mmol/l) from the CGM glucose measurements.

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  15. Coefficient of variation

    The standard deviation of the glucose distribution divided by the mean glucose level.

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

  16. Length of stay

    The amount of time spent in the hospital from admission untill discharge from the hospital

    Measured: From admission untill discharge from the hospital (up to 30 days)

  17. In-hospital complications

    Any in-hospital related complications occurring at least one day after randomization (e.g. acute kidney injury, sepsis, etc.)

    Measured: One day after randomisation until discharge from the hospital (up to 30 days)

  18. Total daily insulin doses

    The amoun of daily insulin given.

    Measured: From inclusion in the trial until discharge from hospital (up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is an investigator-initiated, two-armed, two-site, prospective, randomized, open-label, blindedendpoint (PROBE) trial. The trial is conducted in general medical wards of Herlev-Gentofte Hospital (affiliated with Steno Diabetes Center Copenhagen) and Graz University Hospital (MUG), Austria.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07645079
Sponsor's protocol ID
Inpatient-AID
Status last verified
Oct 2025
First submitted
6 Feb 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bally L, Thabit H, Hartnell S, Andereggen E, Ruan Y, Wilinska ME, Evans ML, Wertli MM, Coll AP, Stettler C, Hovorka R. Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. N Engl J Med. 2018 Aug 9;379(6):547-556. doi: 10.1056/NEJMoa1805233. Epub 2018 Jun 25.

    PubMed 29940126

  • Olsen MT, Klarskov CK, Jensen SH, Rasmussen LM, Lindegaard B, Andersen JA, Gottlieb H, Lunding S, Pedersen-Bjergaard U, Hansen KB, Kristensen PL. In-Hospital Diabetes Management by a Diabetes Team and Insulin Titration Algorithms Based on Continuous Glucose Monitoring or Point-of-Care Glucose Testing in Patients With Type 2 Diabetes (DIATEC): A Randomized Controlled Trial. Diabetes Care. 2025 Apr 1;48(4):569-578. doi: 10.2337/dc24-2222.

    PubMed 39887698

  • Sampson MJ, Singh H, Dhatariya KK, Jones C, Walden E, Bradley C. Psychometric validation and use of a novel diabetes in-patient treatment satisfaction questionnaire. Diabet Med. 2009 Jul;26(7):729-35. doi: 10.1111/j.1464-5491.2009.02754.x.

    PubMed 19573123

  • Benfield T, Jensen JS, Nordestgaard BG. Influence of diabetes and hyperglycaemia on infectious disease hospitalisation and outcome. Diabetologia. 2007 Mar;50(3):549-54. doi: 10.1007/s00125-006-0570-3. Epub 2006 Dec 23.

    PubMed 17187246

  • Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care. 2003 Feb;26(2):510-3. doi: 10.2337/diacare.26.2.510.

    PubMed 12547890

  • Bertoni AG, Saydah S, Brancati FL. Diabetes and the risk of infection-related mortality in the U.S. Diabetes Care. 2001 Jun;24(6):1044-9. doi: 10.2337/diacare.24.6.1044.

    PubMed 11375368

  • YPU_eIFU_REF_700009439_BE-de_V01.pdf [Internet]. [cited 2024 Nov 23]. Available from: https://www.mylife-diabetescare.com/files/media/03_Documents/01_YpsoPump/IFU/1.5/YPU_eIFU_REF_700009439_BE-de_V01.pdf

  • Rubin R, Khanna NR, McIver LA. Aspart Insulin. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK500030/

    PubMed 29763206

  • ART41641-001_rev-A-web.pdf [Internet]. [cited 2024 Nov 23]. Available from: https://freestyleserver.com/payloads/ifu/2023/q3/ART41641-001_rev-A-web.pdf

  • Spanakis EK, Cook CB, Kulasa K, Aloi JA, Bally L, Davis G, Dungan KM, Galindo RJ, Mendez CE, Pasquel FJ, Shah VN, Umpierrez GE, Aaron RE, Tian T, Yeung AM, Huang J, Klonoff DC. A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials. J Diabetes Sci Technol. 2023 Nov;17(6):1527-1552. doi: 10.1177/19322968231191104. Epub 2023 Aug 17.

    PubMed 37592726

  • Boughton CK, Hartnell S, Hobday N, Lake A, Davenport K, Daly A, Ward C, Taylor C, Hovorka R, Bansiya V. Implementation of fully closed-loop insulin delivery for inpatients with diabetes: Real-world outcomes. Diabet Med. 2023 Jun;40(6):e15092. doi: 10.1111/dme.15092. Epub 2023 Mar 28.

    PubMed 36947090

  • Boughton CK, Bally L, Martignoni F, Hartnell S, Herzig D, Vogt A, Wertli MM, Wilinska ME, Evans ML, Coll AP, Stettler C, Hovorka R. Fully closed-loop insulin delivery in inpatients receiving nutritional support: a two-centre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 May;7(5):368-377. doi: 10.1016/S2213-8587(19)30061-0. Epub 2019 Mar 29.

    PubMed 30935872

  • Thabit H, Schofield J. Technology in the management of diabetes in hospitalised adults. Diabetologia. 2024 Oct;67(10):2114-2128. doi: 10.1007/s00125-024-06206-4. Epub 2024 Jul 2.

    PubMed 38953925

  • Hochfellner DA, Rainer R, Ziko H, Aberer F, Simic A, Lichtenegger KM, Beck P, Donsa K, Pieber TR, Fruhwald FM, Rosenkranz AR, Kamolz LP, Baumann PM, Mader JK, Plank J. Efficient and safe glycaemic control with basal-bolus insulin therapy during fasting periods in hospitalized patients with type 2 diabetes using decision support technology: A post hoc analysis. Diabetes Obes Metab. 2021 Sep;23(9):2161-2169. doi: 10.1111/dom.14458. Epub 2021 Jun 22.

    PubMed 34081386

  • Davis GM, Hughes MS, Brown SA, Sibayan J, Perez-Guzman MC, Stumpf M, Thompson Z, Basina M, Patel RM, Hester J, Abraham A, Ly TT, Chaney C, Tan M, Hsu L, Kollman C, Beck RW, Lal R, Buckingham B, Pasquel FJ. Automated Insulin Delivery with Remote Real-Time Continuous Glucose Monitoring for Hospitalized Patients with Diabetes: A Multicenter, Single-Arm, Feasibility Trial. Diabetes Technol Ther. 2023 Oct;25(10):677-688. doi: 10.1089/dia.2023.0304. Epub 2023 Aug 28.

    PubMed 37578778

Questions about this trial

What is this clinical trial studying?

A study testing automated insulin delivery system and GlucoTab in people with Diabetes Mellitus Type 2 and Infection, run by Steno Diabetes Center Copenhagen at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in range (time frame: From inclusion in the trial until discharge from hospital (up to 30 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07645079, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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