Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT06638567
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2024-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Sponsor:
Abraham Hulst, MD, PhD
Organization:
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:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: