Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638567
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-10
Brief Title:
Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUIDE
Brief 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 39-100 mmolL 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 ie 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 9x2x561008 evaluable participants
Keywords
Diabetes mellitus basal bolus sliding scale insulin regimen surgical site infections
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 ie 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 9x2x561008 evaluable participants
Keywords
Diabetes mellitus basal bolus sliding scale insulin regimen surgical site infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None