Diabetes MellitusGluPopNCT03935919
Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery
An observational study of Diabetes Mellitus and Prediabetes, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study it to assess whether the continuous glucose monitor system Dexcom G6® can be reliably used for perioperative glucose monitoring in 20 prediabetic or diabetic patients undergoing abdominal surgery in terms of data continuity, accuracy and patient tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Prediabetes
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Aug 2019to 1 Mar 2020
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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
Study population: The study will involve a total of 20 adults with pre-diabetes, type 1 or type 2 diabetes who will undergo elective abdominal surgery at the University Hospital Bern.
Who may be able to join
- Aged ≥18 years
- Pre-diabetic (HbA1c 5.7-6.5%) or diabetic (regardless of aetiology)
- Scheduled to have elective abdominal surgery at the University Hospital Bern
- Surgery duration >2 hours
Who cannot join
- Planned MRI procedure during hospitalization
- Inability to follow procedures
- Incapacity to give informed consent
- Presence of extensive skin abnormalities at the sensor insertion site (upper arm)
- Known allergic/irritative skin reactions to dressings/adhesives
- Haematocrit values outside the normal range
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- Patients with immunosuppression defined as neutrophil count <0.5x10^9/L
- Patients on isolation precautions (contact, droplet, airborne)
- Pregnancy or breast-feeding
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 Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery - an Observational Study
The purpose of this study it to assess whether the continuous glucose monitor system Dexcom G6® can be reliably used for perioperative glucose monitoring in 20 prediabetic or diabetic patients undergoing abdominal surgery in terms of data continuity, accuracy and patient tolerability.
Read the detailed description
The current recommended method for monitoring glucose control is bedside point of care capillary blood glucose testing. A significant limitation for this method is the frequency by which blood glucose testing is typically performed, at most 4-6 times daily. Continuous glucose monitoring (CGM) provides an alternative approach to measure glucose values with the advantage of greater frequency of monitoring as it is measured every few minutes.
Whilst CGM use in the outpatient setting is rising and has demonstrated benefits on glycaemic control, the accuracy of these devices perioperatively is less investigated. In this study the sixth-generation factory-calibrated real-time Dexcom G6® system will be used as a CGM and its glucose values perioperatively will be compared to the capillary glucose values which will be measured simultaneously by the Accu-Check Inform II (Roche Diagnostics) point-of-care blood glucose meter.
The Investigators aim to assess the feasibility and accuracy of perioperative CGM.
- Conditions
- Diabetes Mellitus, Prediabetes
- Keywords
- perioperative glucose management, continuous glucose monitoring, diabetes
- Medical subject headings
- Diabetes Mellitus, Prediabetic State
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor accuracy in the perioperative period
Mean Absolute Relative Difference (MARD) between Dexcom G6 sensor glucose values and capillary blood glucose values measured using the Accu-Check Inform II meter in the perioperative period (%)
Measured: 1 day
Secondary outcomes (38)
Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)
Mean absolute relative difference between sensor glucose and reference glucose (for reference values >3.9 and <10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the preoperative period (%)
Measured: 1 week
Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)
Mean absolute relative difference between sensor glucose and reference glucose (for reference values >3.9 and <10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the postoperative period (%)
Measured: 1-2 weeks
Median absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)
Median absolute relative difference between sensor glucose and reference glucose (for reference values >3.9 and <10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the preoperative period (%)
Measured: 1 week
Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%)
Median absolute relative difference between sensor glucose and reference glucose (for reference values >3.9 and <10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the perioperative period (%)
Measured: 1 day
Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)
Median absolute relative difference between sensor glucose and reference glucose (for reference values >3.9 and <10.0mmol/l, for reference values ≤3.9mmol/l, for reference values ≥10.0mmol/l) in the postoperative period (%)
Measured: 1-2 weeks
Percentage of sensor measurements in the preoperative period within the limits specified by the International Organization of Standardization (ISO) : 15197:2013 criteria
Proportion of sensor measurements in the preoperative period within ±15% of reference glucose if the reference value is ≥5.6mmol/l and within 0.8mmol/l if the reference values is <5.6mmol/l (%)
Measured: 1 week
Percentage of sensor measurements in the perioperative period within the limits specified by the ISO: 15197:2013 criteria
Proportion of sensor measurements in the perioperative period within ±15% of reference glucose if the reference value is ≥5.6mmol/l and within 0.8mmol/l if the reference values is <5.6mmol/l (%)
Measured: 1 day
Percentage of sensor measurements in the postoperative period within the limits specified by the ISO: 15197:2013 criteria
Proportion of sensor measurements in the postoperative period within ±15% of reference glucose if the reference value is ≥5.6mmol/l and within 0.8mmol/l if the reference values is <5.6mmol/l (%)
Measured: 1-2 weeks
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period
Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period
Measured: 1 week
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period
Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period
Measured: 1 day
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period
Calculation of bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period
Measured: 1-2 weeks
Clarke error grid analysis in the preoperative period
Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E)in the preoperative period (%)
Measured: 1 week
Clarke error grid analysis in the perioperative period
Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E) in the perioperative period (%)
Measured: 1 day
Clarke error grid analysis in the postoperative period
Proportion of sensor glucose values in Clark's error grid zones (A, B, A+B, C, D, E) in the postoperative period (%)
Measured: 1-2 weeks
Sensor availability in the preoperative period (%)
Proportion of study period with available sensor glucose values in the preoperative period
Measured: 1 week
Sensor availability in the perioperative period (%)
Proportion of study period with available sensor glucose values in the perioperative period
Measured: 1 day
Sensor availability in the postoperative period (%)
Proportion of study period with available sensor glucose values in the postoperative period
Measured: 1-2 weeks
Number of sensor replacement events in the preoperative period
Number of times that the sensor needed to be replaced in the preoperative period
Measured: 1 week
Number of sensor replacement events in the perioperative period
Number of times that the sensor needed to be replaced in the perioperative period
Measured: 1 day
Number of sensor replacement events in the postoperative period
Number of times that the sensor needed to be replaced in the postoperative period
Measured: 1-2 weeks
Number of adverse device effects in the preoperative period
Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the preoperative period
Measured: 1 week
Number of adverse device effects in the perioperative period
Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the perioperative period
Measured: 1 day
Number of adverse device effects in the postoperative period
Adverse event related to the use of study devices (e.g. skin irritative and allergic reactions, bleeding) in the postoperative period
Measured: 1-2 weeks
Percentage of time in the preoperative period with sensor glucose levels within target range
Proportion of time in the preoperative period with sensor glucose levels between 3.9-10.0mmol/l
Measured: 1 week
Percentage of time in the perioperative period with sensor glucose levels within target range
Proportion of time in the perioperative period with sensor glucose levels between 3.9-10.0mmol/l
Measured: 1 day
Percentage of time in the postoperative period with sensor glucose levels within target range
Proportion of time in the postoperative period with sensor glucose levels between 3.9-10.0mmol/l
Measured: 1-2 weeks
Percentage of time in the preoperative period with sensor glucose levels below target range
Proportion of time in the preoperative period with sensor glucose levels below 3.9mmol/l
Measured: 1 week
Percentage of time in the perioperative period with sensor glucose levels below target range
Proportion of time in the perioperative period with sensor glucose levels below 3.9mmol/l
Measured: 1 day
Percentage of time in the postoperative period with sensor glucose levels below target range
Proportion of time in the postoperative period with sensor glucose levels below 3.9mmol/l
Measured: 1-2 weeks
Percentage of time in the preoperative period with sensor glucose levels above target range
Proportion of time in the preoperative period with sensor glucose levels above 10.0mmol/l
Measured: 1 week
Percentage of time in the perioperative period with sensor glucose levels above target range
Proportion of time in the perioperative period with sensor glucose levels above 10.0mmol/l
Measured: 1 day
Percentage of time in the postoperative period with sensor glucose levels above target range
Proportion of time in the postoperative period with sensor glucose levels above 10.0mmol/l
Measured: 1-2 weeks
Mean sensor glucose value in the preoperative period
Mean value of the sensor glucose levels in the preoperative period
Measured: 1 week
Mean sensor glucose value in the perioperative period
Mean value of the sensor glucose levels in the perioperative period
Measured: 1 day
Mean sensor glucose value in the postoperative period
Mean value of the sensor glucose levels in the postoperative period
Measured: 1-2 weeks
Standard deviation of sensor glucose levels in the preoperative period
Standard Deviation of the sensor glucose levels in the preoperative period
Measured: 1 week
Standard deviation of sensor glucose levels in the perioperative period
Standard Deviation of the sensor glucose levels in the perioperative period
Measured: 1 day
Standard deviation of sensor glucose levels in the postoperative period
Standard Deviation of the sensor glucose levels in the postoperative period
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start13 Aug 2019
- Primary completion26 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 3 Weeks
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, Inselspital, University Hospital of Bern, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935919
- Sponsor's protocol ID
- GluPop
- Acronym
- GluPop
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery - an Observational Study
- ClinicalTrials.gov ID
- NCT03935919
- Acronym / sponsor ID
- GluPop / GluPop
- Conditions
- Diabetes Mellitus, Prediabetes
- Keywords
- perioperative glucose management, continuous glucose monitoring, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 May 2019 (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 purpose of this study it to assess whether the continuous glucose monitor system Dexcom G6® can be reliably used for perioperative glucose monitoring in 20 prediabetic or diabetic patients undergoing abdominal surgery in terms of data continuity, accuracy and patient tolerability.
Detailed description
The current recommended method for monitoring glucose control is bedside point of care capillary blood glucose testing. A significant limitation for this method is the frequency by which blood glucose testing is typically performed, at most 4-6 times daily. Continuous glucose monitoring (CGM) provides an alternative approach to measure glucose values with the advantage of greater frequency of monitoring as it is measured every few minutes.
Whilst CGM use in the outpatient setting is rising and has demonstrated benefits on glycaemic control, the accuracy of these devices perioperatively is less investigated. In this study the sixth-generation factory-calibrated real-time Dexcom G6® system will be used as a CGM and its glucose values perioperatively will be compared to the capillary glucose values which will be measured simultaneously by the Accu-Check Inform II (Roche Diagnostics) point-of-care blood glucose meter.
The Investigators aim to assess the feasibility and accuracy of perioperative CGM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will involve a total of 20 adults with pre-diabetes, type 1 or type 2 diabetes who will undergo elective abdominal surgery at the University Hospital Bern.
Key inclusion criteria (4 listed)
- Aged ≥18 years
- Pre-diabetic (HbA1c 5.7-6.5%) or diabetic (regardless of aetiology)
- Scheduled to have elective abdominal surgery at the University Hospital Bern
- Surgery duration >2 hours
Key exclusion criteria (9 listed)
- Planned MRI procedure during hospitalization
- Inability to follow procedures
- Incapacity to give informed consent
- Presence of extensive skin abnormalities at the sensor insertion site (upper arm)
- Known allergic/irritative skin reactions to dressings/adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensor accuracy in the perioperative period
Time frame: 1 day
Mean Absolute Relative Difference (MARD) between Dexcom G6 sensor glucose values and capillary blood glucose values measured using the Accu-Check Inform II meter in the perioperative period (%)
38 secondary outcomes
Mean absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)
Time frame: 1 week
Mean absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)
Time frame: 1-2 weeks
Median absolute relative difference between sensor glucose and reference glucose in the preoperative period (%)
Time frame: 1 week
Median absolute relative difference between sensor glucose and reference glucose in the perioperative period (%)
Time frame: 1 day
Median absolute relative difference between sensor glucose and reference glucose in the postoperative period (%)
Time frame: 1-2 weeks
Percentage of sensor measurements in the preoperative period within the limits specified by the International Organization of Standardization (ISO) : 15197:2013 criteria
Time frame: 1 week
Percentage of sensor measurements in the perioperative period within the limits specified by the ISO: 15197:2013 criteria
Time frame: 1 day
Percentage of sensor measurements in the postoperative period within the limits specified by the ISO: 15197:2013 criteria
Time frame: 1-2 weeks
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the preoperative period
Time frame: 1 week
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the perioperative period
Time frame: 1 day
Bias and 95% limits of agreement of sensor glucose compared to reference glucose in the postoperative period
Time frame: 1-2 weeks
Clarke error grid analysis in the preoperative period
Time frame: 1 week
Clarke error grid analysis in the perioperative period
Time frame: 1 day
Clarke error grid analysis in the postoperative period
Time frame: 1-2 weeks
Sensor availability in the preoperative period (%)
Time frame: 1 week
Sensor availability in the perioperative period (%)
Time frame: 1 day
Sensor availability in the postoperative period (%)
Time frame: 1-2 weeks
Number of sensor replacement events in the preoperative period
Time frame: 1 week
Number of sensor replacement events in the perioperative period
Time frame: 1 day
Number of sensor replacement events in the postoperative period
Time frame: 1-2 weeks
Number of adverse device effects in the preoperative period
Time frame: 1 week
Number of adverse device effects in the perioperative period
Time frame: 1 day
Number of adverse device effects in the postoperative period
Time frame: 1-2 weeks
Percentage of time in the preoperative period with sensor glucose levels within target range
Time frame: 1 week
Percentage of time in the perioperative period with sensor glucose levels within target range
Time frame: 1 day
Percentage of time in the postoperative period with sensor glucose levels within target range
Time frame: 1-2 weeks
Percentage of time in the preoperative period with sensor glucose levels below target range
Time frame: 1 week
Percentage of time in the perioperative period with sensor glucose levels below target range
Time frame: 1 day
Percentage of time in the postoperative period with sensor glucose levels below target range
Time frame: 1-2 weeks
Percentage of time in the preoperative period with sensor glucose levels above target range
Time frame: 1 week
Percentage of time in the perioperative period with sensor glucose levels above target range
Time frame: 1 day
Percentage of time in the postoperative period with sensor glucose levels above target range
Time frame: 1-2 weeks
Mean sensor glucose value in the preoperative period
Time frame: 1 week
Mean sensor glucose value in the perioperative period
Time frame: 1 day
Mean sensor glucose value in the postoperative period
Time frame: 1-2 weeks
Standard deviation of sensor glucose levels in the preoperative period
Time frame: 1 week
Standard deviation of sensor glucose levels in the perioperative period
Time frame: 1 day
Standard deviation of sensor glucose levels in the postoperative period
Time frame: 1-2 weeks
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 8 Apr 2020.
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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
Inselspital, University Hospital of Bern, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Prediabetes, 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 4 inclusion and 9 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 8 Apr 2020. 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?
Sensor accuracy in the perioperative period (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2020.