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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Usual Care; Other: Peri-intervention Diabetes Management Algorithm (DIAPI)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lillian Ruiheng Chen, MD; Phone Number: 28252 15148908000; Email: lillian.ruiheng.chen.med@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal
      • Sub-Investigator: Ariane Godbout, MD
      • Contact: Lillian Ruiheng Chen, MD; Phone Number: 28252 15148908000; Email: lillian.ruiheng.chen@umontreal.ca
      • Principal Investigator: Jean-Marie Boutin, MD, PhD
      • Sub-Investigator: Nadine Taleb, MD, PhD
      • Sub-Investigator: Lillian Ruiheng Chen, MD
      • Sub-Investigator: Zoe Lysy, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Patients will receive usual care for their diabetes during their peri-procedural period.	Other: Usual Care; Patients and healthcare workers will apply the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's.
Experimental: DIAPI; 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); Patients and healthcare workers will apply DIAPI's orders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion of participants hospitalized for a diabetes-related condition. (Part 2 of study)		1 month
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)	These episodes will be reported by time frame: the day before, the same day and the day after the intervention.	1 week

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Jean-Marie Boutin, MD, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Endoscopy; Peri-procedural
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2023-11359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No