Clinical trial NCT05849714: Validation Study of a Peri-intervention Diabetes Management Algorithm (DIAPI) for Endoscopy Procedures
Official title: Validation Study of a Peri-intervention Diabetes Management Algorithm (DIAPI) for Endoscopy Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Peri-procedural
Endoscopy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Living with diabetes mellitus for at least 6 months
* Receiving pharmacological treatment for diabetes mellitus
* Awaiting an endoscopy intervention scheduled in 2 weeks or more in order to have time to prepare for the study participation

Exclusion Criteria:

* Undergoing an urgent endoscopy intervention
* Being pregnant
* Currently treated with an insulin pump or the insulin Entuzity

Primary outcomes:
measure: Concordance rate of duplicate prescriptions generated by DIAPI when two different healthcare workers collect data for the same patient. (Part 1 of study)
timeFrame: 1 week
measure: proportion of patients with glycaemia level within target from arrival to departure from the endoscopy unit, i.e. between 4 - 10 mmol/L. (Part 2 of study)
timeFrame: 1 day
Secondary outcomes:
measure: Proportion of DIAPI orders for which the endocrinologist disagrees with at least one of its recommendations. (Part 1 of study)
timeFrame: 1 week
measure: Proportion of participants for whom an endocrinology consultation was recommended by DIAPI. (Part 1 of study)
timeFrame: 1 week
measure: Healthcare workers' satisfaction level with the use of DIAPI, assessed by a questionnaire. (Part 1 of study)
timeFrame: 1 week
measure: Proportion of participants who followed DIAPI recommendations. (Part 2 of study)
timeFrame: 1 week
measure: • Proportion of canceled endoscopies due to dysglycemia, ketoacidosis or for reasons related to diabetes management. (Part 2 of study)
timeFrame: 1 week
measure: Proportion of participants hospitalized for a diabetes-related condition. (Part 2 of study)
timeFrame: 1 month
measure: Proportion of participants who experienced: episode of hypoglycemia <3 and < 4 mmol/L, episode of hyperglycemia >10, > 15 and >20 mmol/L, episode of ketoacidosis. (Part 2 of study)
timeFrame: 1 week
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Jean-Marie Boutin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: