HypoglycaemiaNCT07526103
Developing a Colonoscopy Preparation Protocol for Patients With Diabetes
A study testing timing of cleansing and procedure in people with Hypoglycaemia and Diabete Mellitus, run by Queen's University at 1 site in Canada.
Trial summary
Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoglycaemia, Diabete Mellitus, Colonoscopy (Ambulatory Patients)
- What is being tested?
- timing of cleansing and procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients Age over the age of 18
- Able to read and understand the English language
- Confirmed diagnosis of diabetes (Type 1 or Type 2)
Who cannot join
- Patients without diabetes
- Patients with prior hospital admission due to hypoglycemic events
- Patients who have inflammatory bowel disease
- Patients with ileus or bowel obstruction
- Patients with history of colorectal resection
- Patients receiving combined upper and lower endoscopies
Show all 12Show fewer
- Patients with ascites
- Patients with previously documented severe renal impairment
- Unable to provide consent
- Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
- Patients who have had a recent myocardial infarction(<6months)
- Allergy to product ingredients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
KHSC Hotel Dieu Colonoscopy Suite, 613-548-2342, PatientRelations@KingstonHSC.ca
About this study
Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Furthermore, the peri-colonoscopy period has been associated with increased risk of hypoglycemic events given the required change in diet and possible changes in antihyperglycemic medication regime, though this area is not well studied.
Studies have found that same day preparation for colonoscopy allowed for comparable bowel visualization to split dosing. Pairing this with a low fiber diet permitted the day prior to colonoscopy, the extent of changes to routine and diet within a patient with diabetes day for colonoscopy preparation is minimized and could reduce risk of side effects and hypoglycemia, while also ensuring adequate bowel preparation.
This study tests the hypothesis that creating a diabetic specific protocol (permitting a low fibre diet the day prior to colonoscopy and using same day preparation) will result in fewer hypoglycemic events and more adequate quality preparation in comparison to a conventional 2L PEG split day preparation with dietary restrictions in patients with diabetes.
- Being tested
- timing of cleansing and procedure
- Keywords
- glucose monitoring, diabetes protocol, bowel preparation
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timing of cleansing and procedureOther
we are altering the timing of colonoscopy and cleansing for colonoscopy for patients with diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Preparation) | Active comparator | Participants will follow a clear-liquid diet after breakfast on the day before colonoscopy.
They will ingest 2L of PEG at 7:00 PM the evening before the procedure and the remaining 2L four hours prior to colonoscopy. Receives: Other: timing of cleansing and procedure |
| Diabetes-Specific Protocol Group | Experimental | Participants will follow a four-day, low-fiber carbohydrate diet. They will be allowed to consume dinner up until 7:00 PM the night before the colonoscopy. On the day of the procedure, they will ingest 2L of PEG between 5:00 AM and 6:00 AM and the remaining 2L between 8:00 AM and 9:00 AM. Receives: Other: timing of cleansing and procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Preparation
Primary outcome is the proportion of patients achieving an adequate bowel preparation, defined as a Boston bowel preparation scale (BBPS) score of 6 or greater, with no section scoring below 2 . The scale ranges from 0-9, with 9 being the best possible score.
Measured: During colonoscopy
Secondary outcomes (2)
Glucose Monitoring
Evaluating the incidence of hypoglycemic events (blood glucose <3.9 mmol/L) from the initiation of bowel preparation until discharge from colonoscopy suite.
Measured: Pericolonoscopy period
Patient Rating
Patient-reported ratings of convenience, tolerability and adverse events associated with the preparation protocol.
Measured: Pericolonoscopy period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HypoglycaemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Diabetes-Specific Protocol Group: Participants will follow a four-day, low-fiber carbohydrate diet. They will be allowed to consume dinner up until 7:00 PM the night before the colonoscopy. On the day of the procedure, they will ingest 2L of PEG between 5:00 AM and 6:00 AM and the remaining 2L between 8:00 AM and 9:00 AM. Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device. Control Group (Standard Preparation): Participants will follow a clear-liquid diet after breakfast on the day before colonoscopy. They will ingest 2L of PEG at 7:00 PM the evening before the procedure and the remaining 2L four hours prior to colonoscopy.Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Charles Hookey, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526103
- Sponsor's protocol ID
- 20253698
- Other IDs
- 3698
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tong Y, Huang JQ, Chen Y, Tu M, Wang W. Impact of glucagon-like peptide 1 receptor agonist liraglutide and dipeptidyl peptidase-4 inhibitor sitagliptin on bowel cleaning and gastrointestinal symptoms in type 2 diabetes. Front Pharmacol. 2023 Apr 6;14:1176206. doi: 10.3389/fphar.2023.1176206. eCollection 2023.
PubMed 37089939Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4.
PubMed 27490086Seo M, Gweon TG, Huh CW, Ji JS, Choi H. Comparison of Bowel Cleansing Efficacy, Safety, Bowel Movement Kinetics, and Patient Tolerability of Same-Day and Split-Dose Bowel Preparation Using 4 L of Polyethylene Glycol: A Prospective Randomized Study. Dis Colon Rectum. 2019 Dec;62(12):1518-1527. doi: 10.1097/DCR.0000000000001499.
PubMed 31567921International Hypoglycaemia Study Group. Hypoglycaemia, cardiovascular disease, and mortality in diabetes: epidemiology, pathogenesis, and management. Lancet Diabetes Endocrinol. 2019 May;7(5):385-396. doi: 10.1016/S2213-8587(18)30315-2. Epub 2019 Mar 27.
PubMed 30926258Chirila A, Nguyen ME, Tinmouth J, Halperin IJ. Preparing for Colonoscopy in People with Diabetes: A Review with Suggestions for Clinical Practice. J Can Assoc Gastroenterol. 2022 Dec 30;6(1):26-36. doi: 10.1093/jcag/gwac035. eCollection 2023 Feb.
PubMed 36789141Gandhi K, Tofani C, Sokach C, Patel D, Kastenberg D, Daskalakis C. Patient Characteristics Associated With Quality of Colonoscopy Preparation: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):357-369.e10. doi: 10.1016/j.cgh.2017.08.016. Epub 2017 Aug 18.
PubMed 28826680Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442.
PubMed 18978506Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. doi: 10.1111/j.1572-0241.2001.03610.x.
PubMed 11280539Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13.
PubMed 26460222
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Colonoscopy Preparation Protocol for Patients With Diabetes
- ClinicalTrials.gov ID
- NCT07526103
- Acronym / sponsor ID
- 20253698
- Keywords
- glucose monitoring, diabetes protocol, bowel preparation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Furthermore, the peri-colonoscopy period has been associated with increased risk of hypoglycemic events given the required change in diet and possible changes in antihyperglycemic medication regime, though this area is not well studied.
Studies have found that same day preparation for colonoscopy allowed for comparable bowel visualization to split dosing. Pairing this with a low fiber diet permitted the day prior to colonoscopy, the extent of changes to routine and diet within a patient with diabetes day for colonoscopy preparation is minimized and could reduce risk of side effects and hypoglycemia, while also ensuring adequate bowel preparation.
This study tests the hypothesis that creating a diabetic specific protocol (permitting a low fibre diet the day prior to colonoscopy and using same day preparation) will result in fewer hypoglycemic events and more adequate quality preparation in comparison to a conventional 2L PEG split day preparation with dietary restrictions in patients with diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Diabetes-Specific Protocol Group: Participants will follow a four-day, low-fiber carbohydrate diet. They will be allowed to consume dinner up until 7:00 PM the night before the colonoscopy. On the day of the procedure, they will ingest 2L of PEG between 5:00 AM and 6:00 AM and the remaining 2L between 8:00 AM and 9:00 AM. Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device. Control Group (Standard Preparation): Participants will follow a clear-liquid diet after breakfast on the day before colonoscopy. They will ingest 2L of PEG at 7:00 PM the evening before the procedure and the remaining 2L four hours prior to colonoscopy.Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device.
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Preparation) | Active comparator | Other: timing of cleansing and procedureParticipants will follow a clear-liquid diet after breakfast on the day before colonoscopy. They will ingest 2L of PEG at 7:00 PM the evening before the procedure and the remaining 2L four hours prior to colonoscopy. |
| Diabetes-Specific Protocol Group | Experimental | Other: timing of cleansing and procedureParticipants will follow a four-day, low-fiber carbohydrate diet. They will be allowed to consume dinner up until 7:00 PM the night before the colonoscopy. On the day of the procedure, they will ingest 2L of PEG between 5:00 AM and 6:00 AM and the remaining 2L between 8:00 AM and 9:00 AM. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients Age over the age of 18
- Able to read and understand the English language
- Confirmed diagnosis of diabetes (Type 1 or Type 2)
Key exclusion criteria (12 listed)
- Patients without diabetes
- Patients with prior hospital admission due to hypoglycemic events
- Patients who have inflammatory bowel disease
- Patients with ileus or bowel obstruction
- Patients with history of colorectal resection
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 |
|---|---|---|
| timing of cleansing and procedurewe are altering the timing of colonoscopy and cleansing for colonoscopy for patients with diabetes. | Other | Control Group (Standard Preparation), Diabetes-Specific Protocol Group |
Primary outcome
Bowel Preparation
Time frame: During colonoscopy
Primary outcome is the proportion of patients achieving an adequate bowel preparation, defined as a Boston bowel preparation scale (BBPS) score of 6 or greater, with no section scoring below 2 . The scale ranges from 0-9, with 9 being the best possible score.
2 secondary outcomes
Glucose Monitoring
Time frame: Pericolonoscopy period
Patient Rating
Time frame: Pericolonoscopy period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 37089939Tong Y, Huang JQ, Chen Y, Tu M, Wang W. Impact of glucagon-like peptide 1 receptor agonist liraglutide and dipeptidyl peptidase-4 inhibitor sitagliptin on bowel cleaning and gastrointestinal symptoms in type 2 diabetes. Front Pharmacol. 2023 Apr 6;14:1176206. doi: 10.3389/fphar.2023.1176206. eCollection 2023.
- Background: PubMed 27490086Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4.
- Background: PubMed 31567921Seo M, Gweon TG, Huh CW, Ji JS, Choi H. Comparison of Bowel Cleansing Efficacy, Safety, Bowel Movement Kinetics, and Patient Tolerability of Same-Day and Split-Dose Bowel Preparation Using 4 L of Polyethylene Glycol: A Prospective Randomized Study. Dis Colon Rectum. 2019 Dec;62(12):1518-1527. doi: 10.1097/DCR.0000000000001499.
- Background: PubMed 30926258International Hypoglycaemia Study Group. Hypoglycaemia, cardiovascular disease, and mortality in diabetes: epidemiology, pathogenesis, and management. Lancet Diabetes Endocrinol. 2019 May;7(5):385-396. doi: 10.1016/S2213-8587(18)30315-2. Epub 2019 Mar 27.
- Background: PubMed 36789141Chirila A, Nguyen ME, Tinmouth J, Halperin IJ. Preparing for Colonoscopy in People with Diabetes: A Review with Suggestions for Clinical Practice. J Can Assoc Gastroenterol. 2022 Dec 30;6(1):26-36. doi: 10.1093/jcag/gwac035. eCollection 2023 Feb.
- Background: PubMed 28826680Gandhi K, Tofani C, Sokach C, Patel D, Kastenberg D, Daskalakis C. Patient Characteristics Associated With Quality of Colonoscopy Preparation: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):357-369.e10. doi: 10.1016/j.cgh.2017.08.016. Epub 2017 Aug 18.
- Background: PubMed 18978506Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442.
- Background: PubMed 11280539Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. doi: 10.1111/j.1572-0241.2001.03610.x.
- Background: PubMed 26460222Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing timing of cleansing and procedure in people with Hypoglycaemia and Diabete Mellitus, run by Queen's University 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 12 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: opening soon, as of the sponsor's last update on 24 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lawrence Hookey, MD (613 544 3400 ext. 2292, lawrence.hookey@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Preparation (time frame: During colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07526103, which also lists 9 linked publications.
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 24 Apr 2026.