Perioperative HyperglycaemiaPOP-LOOPNCT04361799
Perioperative Closed-loop Glucose Control
A study testing CamAPS and Standard insulin therapy in people with Perioperative Hyperglycaemia and Insulin Therapy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery
- What is being tested?
- CamAPS and Standard insulin therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2020to 2 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Written informed consent
- The subject is aged 18 years or over
- Diagnosis of type 2 diabetes using standard diagnostic practice (37)
- The subject is planned for an elective abdominal, thoracic or cardiovascular surgery at the University Hospital Bern expected to last ≥2 hours
- The subject requires treatment with subcutaneous insulin as part of the perioperative glucose management
- The subject is literate in German
- The subject is willing to wear study devices 24/7
Who cannot join
- Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Known or suspected allergy to insulin
- Type 1 diabetes
- Pregnancy, planned pregnancy, or breast feeding
- Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
- Lack of safe contraception for female participants of childbearing potential for the entire study duration (medically reliable method of contraception are considered oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or any other methods judged as sufficiently reliable by the investigator in individual cases).
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- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- Illicit drug abuse or prescription drug abuse
- Incapacity to give informed consent
- Droplet/airborne isolation precautions
- Participation in another clinical trial that interferes with the interpretation of the study results
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes
The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management.
- Conditions
- Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas
- Being tested
- CamAPS, Standard insulin therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamAPSDevice
Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
Standard insulin therapyDrug
Standard insulin therapy according to local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop insulin therapy | Experimental | Not described Receives: Device: CamAPS |
| Standard insulin therapy | Active comparator | Not described Receives: Drug: Standard insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L based on sensor glucose levels during the time from hospital admission for elective surgery until discharge.
Measured: Up to 20 days
Secondary outcomes (7)
Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
Measured: Up to 20 days
Proportion of time spent with sensor glucose <3.0 mmol/L
Measured: Up to 20 days
Average of sensor glucose level
Measured: Up to 20 days
Time spent with sensor glucose below target (5.6 mmol/L)
Measured: Up to 20 days
Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)
Measured: Up to 20 days
Standard deviation and coefficient of variation of sensor glucose levels
Measured: Up to 20 days
Total daily insulin requirements
Measured: Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start25 Sep 2020
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative HyperglycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lia Bally, MD PhD, Principal investigator, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361799
- Sponsor's protocol ID
- POP-LOOP
- Acronym
- POP-LOOP
- Status last verified
- Dec 2021
- First submitted
- 22 Apr 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krutkyte G, Roos J, Schuerch D, Czerlau C, Wilinska ME, Wuethrich PY, Herzig D, Hovorka R, Vogt AP, Gloor B, Bally L. Fully Closed-Loop Insulin Delivery in Patients Undergoing Pancreatic Surgery. Diabetes Technol Ther. 2023 Mar;25(3):206-211. doi: 10.1089/dia.2022.0400. Epub 2022 Dec 14.
PubMed 36449375Herzig D, Suhner S, Roos J, Schurch D, Cecchini L, Nakas CT, Weiss S, Kadner A, Kocher GJ, Guensch DP, Wilinska ME, Raabe A, Siebenrock KA, Beldi G, Gloor B, Hovorka R, Vogt AP, Bally L. Perioperative Fully Closed-Loop Insulin Delivery in Patients Undergoing Elective Surgery: An Open-Label, Randomized Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):2076-2083. doi: 10.2337/dc22-0438.
PubMed 35880252
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04361799
- Acronym / sponsor ID
- POP-LOOP / POP-LOOP
- Conditions
- Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop insulin therapy | Experimental | Device: CamAPS |
| Standard insulin therapy | Active comparator | Drug: Standard insulin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent
- The subject is aged 18 years or over
- Diagnosis of type 2 diabetes using standard diagnostic practice (37)
- The subject is planned for an elective abdominal, thoracic or cardiovascular surgery at the University Hospital Bern expected to last ≥2 hours
- The subject requires treatment with subcutaneous insulin as part of the perioperative glucose management
Key exclusion criteria (11 listed)
- Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Known or suspected allergy to insulin
- Type 1 diabetes
- Pregnancy, planned pregnancy, or breast feeding
- Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamAPSFully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements. | Device | Closed-loop insulin therapy |
| Standard insulin therapyStandard insulin therapy according to local clinical practice. | Drug | Standard insulin therapy |
Primary outcome
The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L based on sensor glucose levels during the time from hospital admission for elective surgery until discharge.
Time frame: Up to 20 days
7 secondary outcomes
Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
Time frame: Up to 20 days
Proportion of time spent with sensor glucose <3.0 mmol/L
Time frame: Up to 20 days
Average of sensor glucose level
Time frame: Up to 20 days
Time spent with sensor glucose below target (5.6 mmol/L)
Time frame: Up to 20 days
Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)
Time frame: Up to 20 days
Standard deviation and coefficient of variation of sensor glucose levels
Time frame: Up to 20 days
Total daily insulin requirements
Time frame: Up to 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Derived from this study: PubMed 36449375Krutkyte G, Roos J, Schuerch D, Czerlau C, Wilinska ME, Wuethrich PY, Herzig D, Hovorka R, Vogt AP, Gloor B, Bally L. Fully Closed-Loop Insulin Delivery in Patients Undergoing Pancreatic Surgery. Diabetes Technol Ther. 2023 Mar;25(3):206-211. doi: 10.1089/dia.2022.0400. Epub 2022 Dec 14.
- Derived from this study: PubMed 35880252Herzig D, Suhner S, Roos J, Schurch D, Cecchini L, Nakas CT, Weiss S, Kadner A, Kocher GJ, Guensch DP, Wilinska ME, Raabe A, Siebenrock KA, Beldi G, Gloor B, Hovorka R, Vogt AP, Bally L. Perioperative Fully Closed-Loop Insulin Delivery in Patients Undergoing Elective Surgery: An Open-Label, Randomized Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):2076-2083. doi: 10.2337/dc22-0438.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia Bally, MD PhD principal investigator
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CamAPS and Standard insulin therapy in people with Perioperative Hyperglycaemia and Insulin Therapy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L based on sensor glucose levels during the time from hospital admission for elective surgery until discharge. (time frame: Up to 20 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 NCT04361799, which also lists 2 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 17 Dec 2021.