Validation Study of a Peri-intervention Diabetes Management Algorithm (DIAPI) for Endoscopy Procedures

NCT05849714 | Completed

• 1 other identifier: 2023-11359
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Peri-procedural; Endoscopy

Outcome Measures

Primary Outcomes (2)

• Concordance rate of duplicate prescriptions generated by DIAPI when two different healthcare workers collect data for the same patient. (Part 1 of study)

  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. * Concordance = difference score of ≤ 25.0 %. * Discordant= difference score of \> 25.0 %.

  1 week

• 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)

  The glycaemia will be measured at least every hour for the duration of the stay in the endoscopy unit.

  1 day

Secondary Outcomes (7)

• Proportion of DIAPI orders for which the endocrinologist disagrees with at least one of its recommendations. (Part 1 of study)

  1 week

• Proportion of participants for whom an endocrinology consultation was recommended by DIAPI. (Part 1 of study)

  1 week

• Healthcare workers' satisfaction level with the use of DIAPI, assessed by a questionnaire. (Part 1 of study)

  1 week

• Proportion of participants who followed DIAPI recommendations. (Part 2 of study)

  1 week

• • Proportion of canceled endoscopies due to dysglycemia, ketoacidosis or for reasons related to diabetes management. (Part 2 of study)

  1 week

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Patients will receive usual care for their diabetes during their peri-procedural period.

Other: Usual Care

DIAPI

EXPERIMENTAL

Patients will receive the care for their diabetes recommended by the DIAPI algorithm during their peri-procedural period.

Other: Peri-intervention Diabetes Management Algorithm (DIAPI)

Interventions

Peri-intervention Diabetes Management Algorithm (DIAPI) OTHER

Patients and healthcare workers will apply DIAPI's orders.

DIAPI

Usual Care OTHER

Patients and healthcare workers will apply the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jean-Marie Boutin, MD, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 9, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)