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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849714
• Other study ID #: 2023-11359
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: December 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Lillian Ruiheng Chen, MD
• Phone: 15148908000
• Email: lillian.ruiheng.chen.med[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Peri-intervention Diabetes Management Algorithm (DIAPI)
Patients and healthcare workers will apply DIAPI's orders.
• Usual Care
Patients and healthcare workers will apply the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's.

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Proportion of DIAPI orders for which the endocrinologist disagrees with at least one of its recommendations. (Part 1 of study)		1 week
Secondary	Proportion of participants for whom an endocrinology consultation was recommended by DIAPI. (Part 1 of study)		1 week
Secondary	Healthcare workers' satisfaction level with the use of DIAPI, assessed by a questionnaire. (Part 1 of study)		1 week
Secondary	Proportion of participants who followed DIAPI recommendations. (Part 2 of study)		1 week
Secondary	• Proportion of canceled endoscopies due to dysglycemia, ketoacidosis or for reasons related to diabetes management. (Part 2 of study)		1 week
Secondary	Proportion of participants hospitalized for a diabetes-related condition. (Part 2 of study)		1 month
Secondary	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