Diabetes MellitusNCT05849714
Validation Study of a Peri-intervention Diabetes Management Algorithm (DIAPI) for Endoscopy Procedures
A study testing Peri-intervention Diabetes Management Algorithm (DIAPI) in people with Diabetes Mellitus, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Peri-intervention Diabetes Management Algorithm (DIAPI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Undergoing an urgent endoscopy intervention
- Being pregnant
- Currently treated with an insulin pump or the insulin Entuzity
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
About this study
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.
Read more
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
- Being tested
- Peri-intervention Diabetes Management Algorithm (DIAPI), Usual Care
- Keywords
- Peri-procedural, Endoscopy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-intervention Diabetes Management Algorithm (DIAPI)Other
Patients and healthcare workers will apply DIAPI's orders.
Usual CareOther
Patients and healthcare workers will apply the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Patients will receive usual care for their diabetes during their peri-procedural period. Receives: Other: Usual Care |
| DIAPI | Experimental | Patients will receive the care for their diabetes recommended by the DIAPI algorithm during their peri-procedural period. Receives: Other: Peri-intervention Diabetes Management Algorithm (DIAPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %.
Measured: 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.
Measured: 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)
Measured: 1 week
Proportion of participants for whom an endocrinology consultation was recommended by DIAPI. (Part 1 of study)
Measured: 1 week
Healthcare workers' satisfaction level with the use of DIAPI, assessed by a questionnaire. (Part 1 of study)
Measured: 1 week
Proportion of participants who followed DIAPI recommendations. (Part 2 of study)
Measured: 1 week
• Proportion of canceled endoscopies due to dysglycemia, ketoacidosis or for reasons related to diabetes management. (Part 2 of study)
Measured: 1 week
Proportion of participants hospitalized for a diabetes-related condition. (Part 2 of study)
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Boutin, MD, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849714
- Sponsor's protocol ID
- 2023-11359
- Other IDs
- 2023
- Status last verified
- Feb 2025
- First submitted
- 25 Apr 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of a Peri-intervention Diabetes Management Algorithm (DIAPI) for Endoscopy Procedures
- ClinicalTrials.gov ID
- NCT05849714
- Acronym / sponsor ID
- 2023-11359
- Conditions
- Diabetes Mellitus
- Keywords
- Peri-procedural, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CarePatients will receive usual care for their diabetes during their peri-procedural period. |
| DIAPI | Experimental | Other: Peri-intervention Diabetes Management Algorithm (DIAPI)Patients will receive the care for their diabetes recommended by the DIAPI algorithm during their peri-procedural period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Undergoing an urgent endoscopy intervention
- Being pregnant
- Currently treated with an insulin pump or the insulin Entuzity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-intervention Diabetes Management Algorithm (DIAPI)Patients and healthcare workers will apply DIAPI's orders. | Other | DIAPI |
| Usual CarePatients and healthcare workers will apply the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's. | Other | Usual Care |
Primary outcome
Concordance rate of duplicate prescriptions generated by DIAPI when two different healthcare workers collect data for the same patient. (Part 1 of study)
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. * Concordance = difference score of ≤ 25.0 %. * Discordant= difference score of > 25.0 %.
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)
Time frame: 1 day
The glycaemia will be measured at least every hour for the duration of the stay in the endoscopy unit.
7 secondary outcomes
Proportion of DIAPI orders for which the endocrinologist disagrees with at least one of its recommendations. (Part 1 of study)
Time frame: 1 week
Proportion of participants for whom an endocrinology consultation was recommended by DIAPI. (Part 1 of study)
Time frame: 1 week
Healthcare workers' satisfaction level with the use of DIAPI, assessed by a questionnaire. (Part 1 of study)
Time frame: 1 week
Proportion of participants who followed DIAPI recommendations. (Part 2 of study)
Time frame: 1 week
• Proportion of canceled endoscopies due to dysglycemia, ketoacidosis or for reasons related to diabetes management. (Part 2 of study)
Time frame: 1 week
Proportion of participants hospitalized for a diabetes-related condition. (Part 2 of study)
Time frame: 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)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Boutin, MD, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peri-intervention Diabetes Management Algorithm (DIAPI) in people with Diabetes Mellitus, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate of duplicate prescriptions generated by DIAPI when two different healthcare workers collect data for the same patient. (Part 1 of study) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.