Diabetes Mellitus, Type 2GUIDENCT06638567
Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
A study testing Basal bolus insulin regimen in people with Diabetes Mellitus, Type 2 and Surgical Site Infection, run by Abraham Hulst, MD, PhD at 1 site in Netherlands.
Trial summary
A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Surgical Site Infection
- What is being tested?
- Basal bolus insulin regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Jan 2025to Sep 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
- Patients aged 18 or older
- Diagnosed with type 2 diabetes mellitus
- Undergoing gastointestinal or vascular surgery
- Admitted to one of the participating surgical wards
- Expected duration of stay at least one overnight stay
- Willing and able to provide informed consent
Who cannot join
- Diagnosed with type 1 diabetes mellitus
- Female of child-bearing potential who is pregnant or breastfeeding.
- Undergoing complete pancreatectomy
- Undergoing bariatric surgery
- Patients using a continuous insulin pump at home
- Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Ayla Y. Stobbe, MD, 020-5669111, guide_research@amsterdamumc.nl
About this study
Official title: Postoperative Glucose Control with a Basal Bolus Versus Sliding Scale Insulin Regimen and Its Effect on the Incidence of Surgical Site Infections in People with Type 2 Diabetes Mellitus.
A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.
Read the detailed description
People with type 2 diabetes mellitus (PWT2D) are at increased risk of postoperative complications, especially surgical site infections (SSI).
The aim of this study to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to the reactive sliding scale regimen.
Adult patients with type 2 diabetes will be included in this multi-centre study.
Participants will receive a blind CGM, i.e. glucose data are masked for the participants and study team, from admission to the ward until discharge from the hospital. In addition, all participants are asked to complete several questionnaires 30 days after surgery.
Both regimens are currently used in clinical practice. Therefore, there is no additional trial-related burden depending on the intervention group allocation.
Participants will be monitored intensively and insulin dosage will be adjusted adequately to the measured glucose values by the treatment team.
The sample size is based on the SSI incidence rates. Wards are matched into pairs with comparable baseline incidence rates and in each pair, one ward will be randomly assigned to the intervention group; the other serves as the control. 18 wards from 8 participating centres are planned to be recruited, this translates to 9x2x56=1008 evaluable participants.
Keywords:
Diabetes mellitus, basal bolus, sliding scale, insulin regimen, surgical site infections
- Conditions
- Diabetes Mellitus, Type 2, Surgical Site Infection
- Being tested
- Basal bolus insulin regimen
- Keywords
- Diabetes Mellitus, Basal bolus regimen, Surgical site infections, Sliding scale, Insulin regimen
- Medical subject headings
- Diabetes Mellitus, Type 2, Surgical Wound Infection, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basal bolus insulin regimenOther
Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Basal Bolus | Experimental | Patients daily dose of insulin is calculated by their treatment team: In insulin naive patients 0.4-0.5IU/kg and 0,3IU/kg for patients aged>70 or patients with impaired kidney function with an estimated glucose filtration rate <60ml/min and 80-100% of own insulin for insulin-users. They receive half of this daily dose in long-acting insulin once a day. The other half of their total daily dose of insulin is provided as short-acting mealtime insulin. This short-acting insulin is administered before each meal. When needed, extra insulin can be given when needed.
The measurements of blood glucose values are before each meal and at bedtime (4x/day). Receives: Other: Basal bolus insulin regimen |
| Sliding Scale | No intervention | Short-acting insulin is administered when blood glucose value is above 10,0 mmol/L according to a standardized dosage schedule. The measurements of blood glucose values are before each meal and at bedtime (4x/day). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Incidence of postoperative surgical site infection, according to the criteria of the centres of disease control (CDC) for superficial incisional SSI, deep incisional SSI and organ / space SSI.
SSIs will be measured at 30 days postoperatively via BLUEBELLE questionnaire, diagnosis by surgeon during standard postoperative visit at the surgery clinic 3-5 weeks after surgery and chart review.
Measured: Until 30 days after surgery
Secondary outcomes (15)
Postoperative hospital-acquired infections (non-SSI)
Incidence of hospital-acquired infections, other than surgical site infections
Measured: Recorded at 30 days postoperatively
Length of stay in the hospital (LoS-Hos)
Length of stay in the hospital, measured in days from admission to discharge from the hospital.
Measured: Recorded at 30 days postoperatively
Hospital readmission
Rate of hospital readmissions within 30 days after surgery
Measured: Recorded 30 days postoperatively
Days at home (DAH30)
Patient-reported number of days at home after surgery, between 0 and 30.
Measured: Recorded 30 days postoperatively
Postoperative disability
Patient-reported level of disability 30 days after surgery, using the WHODAS-2.0 questionnaire. Summarized in a score between 0-100.
Measured: Recorded 30 days postoperatively
Quality of life (QoL) after surgery
Patient-reported health-related quality of life 30 days after surgery, using the EuroQol 5D5L questionnaire, summarized in a score between 0 and 1.
Measured: Recorded 30 days postoperatively
Glucose 2
Incidence of grade 2 hypoglycemia, a blood glucose below 3.0mmol/L.
Measured: Measured 4 times a day, until discharge from the hospital, up to 30 days.
Glucose 3
Incidence of grade 1 hyperglycemia, a blood glucose above 10.0mmol/L.
Measured: Measured 4 times a day, until discharge from the hospital, up to 30 days.
Glucose 4
Incidence of grade 2 hyperglycemia, a blood glucose above 14.0mmol/L.
Measured: Measured 4 times a day, until discharge from the hospital, up to 30 days.
CGM1
Percentage of time within glycaemic target range (3.9-10.0 mmol/L) per day and over hospital admission. This is measured with the continuous glucose monitor (CGM).
Measured: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
CGM2
Percentage of time below glycaemic target range (<3.9mmol/L) per day and over hospital admission. This is measured with the continuous glucose monitor (CGM).
Measured: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
CGM3
Percentage of time above glycaemic target range (>10.0mmol/L) per day and over hospital admission. This is measured with the continuous glucose monitor (CGM).
Measured: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
Cost-effectiveness 1
The cost-effectiveness of the basal bolus insulin regimen compared to the sliding scale regimen, considering the costs per prevented of SSI in a cost-effectiveness analysis.
Measured: Until 30 days after surgery
Cost-effectiveness 2
The number of quality adjusted life years (QALYs) gained after a cost-utility analysis.
Measured: Up to 30 days after surgery.
Protocol adherence
The adherence to the protocol until discharge from the hospital
Measured: During the hospital stay, until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start3 Jan 2025
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, matched, cluster-randomised
- Masking
- None (open label)
- Enrolment
- 1,008 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abraham Hulst, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor-investigator, Abraham Hulst, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Sarah E. Siegelaar, MD, PhD, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638567
- Sponsor's protocol ID
- GUIDE trial
- Acronym
- GUIDE
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete data collection methods and results will be shared with other researchers upon a formal request made to the principal investigator including a detailed motivation for the request.
Publications
Kao LS, Phatak UR. Glycemic control and prevention of surgical site infection. Surg Infect (Larchmt). 2013 Oct;14(5):437-44. doi: 10.1089/sur.2013.008. Epub 2013 Oct 10.
PubMed 24111757Kotagal M, Symons RG, Hirsch IB, Umpierrez GE, Dellinger EP, Farrokhi ET, Flum DR; SCOAP-CERTAIN Collaborative. Perioperative hyperglycemia and risk of adverse events among patients with and without diabetes. Ann Surg. 2015 Jan;261(1):97-103. doi: 10.1097/SLA.0000000000000688.
PubMed 25133932Polderman JA, Van Velzen L, Wasmoeth LG, Eshuis JH, Houweling PL, Hollmann MW, Devries JH, Preckel B, Hermanides J. Hyperglycemia and ambulatory surgery. Minerva Anestesiol. 2015 Sep;81(9):951-9. Epub 2015 Jan 16.
PubMed 25592489de Vries FE, Gans SL, Solomkin JS, Allegranzi B, Egger M, Dellinger EP, Boermeester MA. Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection. Br J Surg. 2017 Jan;104(2):e95-e105. doi: 10.1002/bjs.10424. Epub 2016 Nov 30.
PubMed 27901264Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.
PubMed 21228246de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
PubMed 19398246Phillips VL, Byrd AL, Adeel S, Peng L, Smiley DD, Umpierrez GE. A Comparison of Inpatient Cost Per Day in General Surgery Patients with Type 2 Diabetes Treated with Basal-Bolus versus Sliding Scale Insulin Regimens. Pharmacoecon Open. 2017;1(2):109-115. doi: 10.1007/s41669-017-0020-9. Epub 2017 Apr 21.
PubMed 28660256Koek MBG, van der Kooi TII, Stigter FCA, de Boer PT, de Gier B, Hopmans TEM, de Greeff SC; Burden of SSI Study Group. Burden of surgical site infections in the Netherlands: cost analyses and disability-adjusted life years. J Hosp Infect. 2019 Nov;103(3):293-302. doi: 10.1016/j.jhin.2019.07.010. Epub 2019 Jul 19.
PubMed 31330166Fowler AJ, Wahedally MAH, Abbott TEF, Smuk M, Prowle JR, Pearse RM, Cromwell DA. Death after surgery among patients with chronic disease: prospective study of routinely collected data in the English NHS. Br J Anaesth. 2022 Feb;128(2):333-342. doi: 10.1016/j.bja.2021.11.011. Epub 2021 Dec 20.
PubMed 34949439Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
PubMed 19465235Lai J, Li Q, He Y, Zou S, Bai X, Rastogi S. Glycemic Control Regimens in the Prevention of Surgical Site Infections: A Meta-Analysis of Randomized Clinical Trials. Front Surg. 2022 Mar 25;9:855409. doi: 10.3389/fsurg.2022.855409. eCollection 2022.
PubMed 35402490Colunga-Lozano LE, Gonzalez Torres FJ, Delgado-Figueroa N, Gonzalez-Padilla DA, Hernandez AV, Roman Y, Cuello-Garcia CA. Sliding scale insulin for non-critically ill hospitalised adults with diabetes mellitus. Cochrane Database Syst Rev. 2018 Nov 29;11(11):CD011296. doi: 10.1002/14651858.CD011296.pub2.
PubMed 30488948Okabayashi T, Shima Y, Sumiyoshi T, Kozuki A, Tokumaru T, Iiyama T, Sugimoto T, Kobayashi M, Yokoyama M, Hanazaki K. Intensive versus intermediate glucose control in surgical intensive care unit patients. Diabetes Care. 2014 Jun;37(6):1516-24. doi: 10.2337/dc13-1771. Epub 2014 Mar 12.
PubMed 24623024Yuan J, Liu T, Zhang X, Si Y, Ye Y, Zhao C, Wang Q, Shen X. Intensive Versus Conventional Glycemic Control in Patients with Diabetes During Enteral Nutrition After Gastrectomy. J Gastrointest Surg. 2015 Aug;19(8):1553-8. doi: 10.1007/s11605-015-2871-7. Epub 2015 Jun 18.
PubMed 26084869Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.
PubMed 17513708
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Glucose Control with a Basal Bolus Versus Sliding Scale Insulin Regimen and Its Effect on the Incidence of Surgical Site Infections in People with Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT06638567
- Acronym / sponsor ID
- GUIDE / GUIDE trial
- Conditions
- Diabetes Mellitus, Type 2, Surgical Site Infection
- Keywords
- Diabetes Mellitus, Basal bolus regimen, Surgical site infections, Sliding scale, Insulin regimen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,008 participants (estimated)
- Lead sponsor
- Abraham Hulst, MD, PhDUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.
Detailed description
People with type 2 diabetes mellitus (PWT2D) are at increased risk of postoperative complications, especially surgical site infections (SSI).
The aim of this study to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to the reactive sliding scale regimen.
Adult patients with type 2 diabetes will be included in this multi-centre study.
Participants will receive a blind CGM, i.e. glucose data are masked for the participants and study team, from admission to the ward until discharge from the hospital. In addition, all participants are asked to complete several questionnaires 30 days after surgery.
Both regimens are currently used in clinical practice. Therefore, there is no additional trial-related burden depending on the intervention group allocation.
Participants will be monitored intensively and insulin dosage will be adjusted adequately to the measured glucose values by the treatment team.
The sample size is based on the SSI incidence rates. Wards are matched into pairs with comparable baseline incidence rates and in each pair, one ward will be randomly assigned to the intervention group; the other serves as the control. 18 wards from 8 participating centres are planned to be recruited, this translates to 9x2x56=1008 evaluable participants.
Keywords:
Diabetes mellitus, basal bolus, sliding scale, insulin regimen, surgical site infections
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, matched, cluster-randomised
| Arm | Type | Receives |
|---|---|---|
| Basal Bolus | Experimental | Other: Basal bolus insulin regimenPatients daily dose of insulin is calculated by their treatment team: In insulin naive patients 0.4-0.5IU/kg and 0,3IU/kg for patients aged>70 or patients with impaired kidney function with an estimated glucose filtration rate <60ml/min and 80-100% of own insulin for insulin-users. They receive half of this daily dose in long-acting insulin once a day. The other half of their total daily dose of insulin is provided as short-acting mealtime insulin. This short-acting insulin is administered before each meal. When needed, extra insulin can be given when needed. The measurements of blood glucose values are before each meal and at bedtime (4x/day). |
| Sliding Scale | No intervention | –Short-acting insulin is administered when blood glucose value is above 10,0 mmol/L according to a standardized dosage schedule. The measurements of blood glucose values are before each meal and at bedtime (4x/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 or older
- Diagnosed with type 2 diabetes mellitus
- Undergoing gastointestinal or vascular surgery
- Admitted to one of the participating surgical wards
- Expected duration of stay at least one overnight stay
Key exclusion criteria (6 listed)
- Diagnosed with type 1 diabetes mellitus
- Female of child-bearing potential who is pregnant or breastfeeding.
- Undergoing complete pancreatectomy
- Undergoing bariatric surgery
- Patients using a continuous insulin pump at home
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 |
|---|---|---|
| Basal bolus insulin regimenCombination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively | Other | Basal Bolus |
Primary outcome
Surgical site infection
Time frame: Until 30 days after surgery
Incidence of postoperative surgical site infection, according to the criteria of the centres of disease control (CDC) for superficial incisional SSI, deep incisional SSI and organ / space SSI. SSIs will be measured at 30 days postoperatively via BLUEBELLE questionnaire, diagnosis by surgeon during standard postoperative visit at the surgery clinic 3-5 weeks after surgery and chart review.
15 secondary outcomes
Postoperative hospital-acquired infections (non-SSI)
Time frame: Recorded at 30 days postoperatively
Length of stay in the hospital (LoS-Hos)
Time frame: Recorded at 30 days postoperatively
Hospital readmission
Time frame: Recorded 30 days postoperatively
Days at home (DAH30)
Time frame: Recorded 30 days postoperatively
Postoperative disability
Time frame: Recorded 30 days postoperatively
Quality of life (QoL) after surgery
Time frame: Recorded 30 days postoperatively
Glucose 2
Time frame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
Glucose 3
Time frame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
Glucose 4
Time frame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
CGM1
Time frame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
CGM2
Time frame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
CGM3
Time frame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
Cost-effectiveness 1
Time frame: Until 30 days after surgery
Cost-effectiveness 2
Time frame: Up to 30 days after surgery.
Protocol adherence
Time frame: During the hospital stay, until discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Background: PubMed 24111757Kao LS, Phatak UR. Glycemic control and prevention of surgical site infection. Surg Infect (Larchmt). 2013 Oct;14(5):437-44. doi: 10.1089/sur.2013.008. Epub 2013 Oct 10.
- Background: PubMed 25133932Kotagal M, Symons RG, Hirsch IB, Umpierrez GE, Dellinger EP, Farrokhi ET, Flum DR; SCOAP-CERTAIN Collaborative. Perioperative hyperglycemia and risk of adverse events among patients with and without diabetes. Ann Surg. 2015 Jan;261(1):97-103. doi: 10.1097/SLA.0000000000000688.
- Background: PubMed 25592489Polderman JA, Van Velzen L, Wasmoeth LG, Eshuis JH, Houweling PL, Hollmann MW, Devries JH, Preckel B, Hermanides J. Hyperglycemia and ambulatory surgery. Minerva Anestesiol. 2015 Sep;81(9):951-9. Epub 2015 Jan 16.
- Background: PubMed 27901264de Vries FE, Gans SL, Solomkin JS, Allegranzi B, Egger M, Dellinger EP, Boermeester MA. Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection. Br J Surg. 2017 Jan;104(2):e95-e105. doi: 10.1002/bjs.10424. Epub 2016 Nov 30.
- Background: PubMed 21228246Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.
- Background: PubMed 19398246de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
- Background: PubMed 28660256Phillips VL, Byrd AL, Adeel S, Peng L, Smiley DD, Umpierrez GE. A Comparison of Inpatient Cost Per Day in General Surgery Patients with Type 2 Diabetes Treated with Basal-Bolus versus Sliding Scale Insulin Regimens. Pharmacoecon Open. 2017;1(2):109-115. doi: 10.1007/s41669-017-0020-9. Epub 2017 Apr 21.
- Background: PubMed 31330166Koek MBG, van der Kooi TII, Stigter FCA, de Boer PT, de Gier B, Hopmans TEM, de Greeff SC; Burden of SSI Study Group. Burden of surgical site infections in the Netherlands: cost analyses and disability-adjusted life years. J Hosp Infect. 2019 Nov;103(3):293-302. doi: 10.1016/j.jhin.2019.07.010. Epub 2019 Jul 19.
- Background: PubMed 34949439Fowler AJ, Wahedally MAH, Abbott TEF, Smuk M, Prowle JR, Pearse RM, Cromwell DA. Death after surgery among patients with chronic disease: prospective study of routinely collected data in the English NHS. Br J Anaesth. 2022 Feb;128(2):333-342. doi: 10.1016/j.bja.2021.11.011. Epub 2021 Dec 20.
- Background: PubMed 19465235Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
- Background: PubMed 35402490Lai J, Li Q, He Y, Zou S, Bai X, Rastogi S. Glycemic Control Regimens in the Prevention of Surgical Site Infections: A Meta-Analysis of Randomized Clinical Trials. Front Surg. 2022 Mar 25;9:855409. doi: 10.3389/fsurg.2022.855409. eCollection 2022.
- Background: PubMed 30488948Colunga-Lozano LE, Gonzalez Torres FJ, Delgado-Figueroa N, Gonzalez-Padilla DA, Hernandez AV, Roman Y, Cuello-Garcia CA. Sliding scale insulin for non-critically ill hospitalised adults with diabetes mellitus. Cochrane Database Syst Rev. 2018 Nov 29;11(11):CD011296. doi: 10.1002/14651858.CD011296.pub2.
- Individual participant dataSharing planned: Yes. Complete data collection methods and results will be shared with other researchers upon a formal request made to the principal investigator including a detailed motivation for the request.
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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.
Sarah E. Siegelaar, MD, PhD principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basal bolus insulin regimen in people with Diabetes Mellitus, Type 2 and Surgical Site Infection, run by Abraham Hulst, MD, PhD at 1 site in Netherlands.
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 6 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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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 Netherlands. 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?
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?
Contact Ayla Y. Stobbe, MD (0031205669111, a.y.stobbe@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: Until 30 days after surgery). 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 NCT06638567, which also lists 17 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 30 Jan 2025.