Colonoscopy (Ambulatory Patients), Diabete Mellitus, Hypoglycaemia
Conditions
Keywords
glucose monitoring, diabetes protocol, bowel preparation
Brief 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. 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.
Interventions
OTHERtiming of cleansing and procedure
we are altering the timing of colonoscopy and cleansing for colonoscopy for patients with diabetes.
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients Age over the age of 18 2. Able to read and understand the English language 3. Confirmed diagnosis of diabetes (Type 1 or Type 2)
Exclusion criteria
1. Patients without diabetes 2. Patients with prior hospital admission due to hypoglycemic events 3. Patients who have inflammatory bowel disease 4. Patients with ileus or bowel obstruction 5. Patients with history of colorectal resection 6. Patients receiving combined upper and lower endoscopies 7. Patients with ascites 8. Patients with previously documented severe renal impairment 9. Unable to provide consent 10. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing) 11. Patients who have had a recent myocardial infarction(\<6months) 12. Allergy to product ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Preparation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Monitoring | Pericolonoscopy period | Evaluating the incidence of hypoglycemic events (blood glucose \<3.9 mmol/L) from the initiation of bowel preparation until discharge from colonoscopy suite. |
| Patient Rating | Pericolonoscopy period | Patient-reported ratings of convenience, tolerability and adverse events associated with the preparation protocol. |
Countries
Canada
Contacts
CONTACTLawrence Hookey, MD
CONTACTAmani Khan, MD
Outcome results
None listed