An interventional study of automated insulin delivery system and GlucoTab in Diabetes Mellitus Type 2, Infection and CGM, sponsored by Steno Diabetes Center Copenhagen. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment
Among 30 studies in Diabetes Mellitus, Type 2 by Steno Diabetes Center Copenhagen — 8 open to participants now, 9 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Steno Diabetes Center Copenhagen.
Among the 30 studies in Diabetes Mellitus, Type 2 by Steno Diabetes Center Copenhagen, this one is the 12th largest by planned enrollment of the 23 interventional ones, is one of 4 that started in 2026, is one of 16 with no phase, and was the 27th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 92 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →8 of the 30 studies in Diabetes Mellitus, Type 2 by Steno Diabetes Center Copenhagen are open now, in 2 countries. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 4 started in 2026.
Median enrollment 92 across the 23 interventional studies, 148 across the 6 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.
Steno Diabetes Center Copenhagen is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
3 of the studies in Diabetes Mellitus, Type 2 by Steno Diabetes Center Copenhagen that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07262788Steno Diabetes Center CopenhagenA Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes | 2027-03 |
| NCT07645079Steno Diabetes Center CopenhagenAutomated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care | 2027-07-15 |
| NCT07641309Steno Diabetes Center CopenhagenMeasurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality | 2027-09 |
Among the 30 studies in Diabetes Mellitus, Type 2 by Steno Diabetes Center Copenhagen, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnoses/treatments/clinical parameters prohibiting use of Insulin/AID such as
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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
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
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
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
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
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
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
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
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
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
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
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).
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Hypoglycemic event level 2
Hypoglycemic events (defined as three consecutive CGM measures) in the range of \<54 mg/dl (\<3.0 mmol/l).
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
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.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
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
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Glycemia risk index
Defined by the formula \[3.0 × % time below 54mg/dl (3.0 mmol/l)\] +\[2.4 × % time below 70mg/dl (3.9 mmol/l)\] + \[1.6 × % time above 180mg/dl (10.0 mmol/l)\] + \[0.8 × % time above 250mg/dl (13.9 mmol/l)\].
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Prolonged hypoglycemic events level 1
A hypoglycaemic event 54 - 70 mg/dl (3.0 - 3.9 mmol/l) continuously for at least 120 minutes.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Prolonged hypoglycemic event level 2
A hypoglycaemic event \<54 mg/dl (\<3.0 mmol/l) continuously for at least 120 minutes.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Severe hypoglycemia
Patient requires assistance to correct hypoglycemia.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Mean sensor glucose
Mean sensor glucose from the CGM in mg/dl (mmol/l).
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Standard deviation of the glucose distribution
The standard deviation mg/dl (mmol/l) from the CGM glucose measurements.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Coefficient of variation
The standard deviation of the glucose distribution divided by the mean glucose level.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Length of stay
The amount of time spent in the hospital from admission untill discharge from the hospital
Time frame: From admission untill discharge from the hospital (up to 30 days)
In-hospital complications
Any in-hospital related complications occurring at least one day after randomization (e.g. acute kidney injury, sepsis, etc.)
Time frame: One day after randomisation until discharge from the hospital (up to 30 days)
Total daily insulin doses
The amoun of daily insulin given.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Questionnaires
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.
Time frame: From inclusion in the trial until discharge from hospital (up to 30 days)
Time management
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).
Time frame: From inclusion until discharge from hospital (up to 30 days)
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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