Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1, Canada
NCT Number: NCT05849714
The peri-endoscopy management of diabetes mellitus creates significant challenges for both patients and healthcare professionals. These procedures require fasting and in certain situations, such as prior to a colonoscopy, the diet must be modified the day before the intervention and patients need to take a laxative. These factors put patients at high risk for hyperglycemia and hypoglycemia. Inadequate diabetes control or the continuation of certain medications during this period can be dangerous for the patient and lead to the cancellation of the procedure.
DIAPI is a web application designed to generate orders for optimal and personalized treatment based on each patient's antidiabetic treatment, their glycemic control, their risk of hypoglycemia, and the intervention-related variables. DIAPI's algorithm is established on current evidence-based data when available, and experts' opinions.
Information generated by DIAPI:
* For the patient: Clear instructions regarding their diabetes medication management for the days preceding and the day of the endoscopy. * For the health care team:
* Clear instructions regarding patient's diabetes medication management for the days preceding and the day of the endoscopy; * Individualized hyperglycemia protocol; * Hypoglycemia protocol; * Guidelines if SGLT2 inhibitors have not been discontinued pre-intervention; * Suggestion on whether an Endocrinology consultation is needed.
DIAPI aims to simplify the complex task of peri-intervention diabetes management while ensuring patient safety. It is a cost-effective solution that can lead to a reduction of unnecessary Endocrinology consultations, a decrease in nurses' workload, a lessening of the risk of errors and a diminution of endoscopy cancellation.
The validation study is divided into two main phases.
* Phase 1 - Concordance. The investigators will assess the reproducibility of DIAPI orders when two different healthcare workers (an endocrinologist and a nurse) collect data for the same patient. The investigators hypothesize that DIAPI orders are concordant in 80%. Patients in this phase will be subjected to the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's. This group will be the control arm for the non-inferiority study (Phase 2). * Phase 2 - Non-inferiority study. The investigators hypothesize that DIAPI's orders are not inferior to the recommendations issued by the treating-physician in terms of efficacy and security. Patients in this phase will be subjected DIAPI's orders. This group will be the intervention arm for the non-inferiority study.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H2X 0C1, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients and healthcare workers will apply DIAPI's orders.
Patients and healthcare workers will apply the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's.
Time frame: 1 week
Concordance and discordance are dichotomic concepts. To classify this binary issue, the investigators use a home-made ''Difference Score''. The components of this score have been established to ensure patient safety by minimizing the risk of hypoglycemia, hyperglycemia, and diabetic ketoacidosis.
Time frame: 1 day
The glycaemia will be measured at least every hour for the duration of the stay in the endoscopy unit.
Time frame: 1 week
Time frame: 1 week
Time frame: 1 week
Time frame: 1 week
Time frame: 1 week
Time frame: 1 month
Time frame: 1 week
These episodes will be reported by time frame: the day before, the same day and the day after the intervention.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
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