Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care

NCT07645079 | Not Yet Recruiting DMC

• 1 other identifier: Inpatient-AID
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 2

Brief 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 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.

Conditions

CGM; Diabetes Mellitus Type 2; Infection

Keywords

automated insulin delivery systems; AID; CGM; continouse glucose monitoring; infectiouse disease; type 2 diabetes mellitus; diabetes mellitus type 2; GlucoTab

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (18)

• Time above range level 1

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

• Time above range level 2

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

• Time below range level 1

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

• Time below range level 2

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

• Hypoglycemic events level 1

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

Other Outcomes (2)

• Questionnaires

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

• Time management

  From inclusion until discharge from hospital (up to 30 days)

Study Arms (2)

AID-arm

EXPERIMENTAL

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.

Device: automated insulin delivery system

Control-Arm

PLACEBO COMPARATOR

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; Procedure: Control-arm

Interventions

automated insulin delivery system DEVICE

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

Also known as: AID, cloosed-loop system

AID-arm

GlucoTab PROCEDURE

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-Arm

Control-arm PROCEDURE

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

Control-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (2)

University Hospital of Graz

Graz, Styria, 8036, Austria

Location

Steno Diabetes Center Copenhagen

Copenhagen, 2730, Denmark

Location

Related Publications (16)

• 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.

  PMID: 29940126 BACKGROUND

• 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.

  PMID: 39887698 BACKGROUND

• 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.

  PMID: 19573123 BACKGROUND

• 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.

  PMID: 17187246 BACKGROUND

• 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.

  PMID: 12547890 BACKGROUND

• 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.

  PMID: 11375368 BACKGROUND

• 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

  BACKGROUND

• 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/

  PMID: 29763206 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 37592726 BACKGROUND

• 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.

  PMID: 36947090 BACKGROUND

• 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.

  PMID: 30935872 BACKGROUND

• 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.

  PMID: 38953925 BACKGROUND

• 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.

  PMID: 34081386 BACKGROUND

• 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.

  PMID: 37578778 BACKGROUND

• Thabit H, Hartnell S, Allen JM, Lake A, Wilinska ME, Ruan Y, Evans ML, Coll AP, Hovorka R. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):117-124. doi: 10.1016/S2213-8587(16)30280-7. Epub 2016 Nov 9.

  PMID: 27836235 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Infections

Interventions

Pancreas, Artificial; Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies; Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The CGM-arm will be masked, the AID-arm will be open-label.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2025-10

Locations

AU (1); DK (1)