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Developing a Colonoscopy Preparation Protocol for Patients With Diabetes

ConditionsHypoglycaemiaDiabete MellitusColonoscopy (Ambulatory Patients)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQueen's University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients Age over the age of 18

Able to read and understand the English language

Confirmed diagnosis of diabetes (Type 1 or Type 2)

Disqualifiers

Patients without diabetes

Patients with prior hospital admission due to hypoglycemic events

Patients who have inflammatory bowel disease

Patients with ileus or bowel obstruction

Trial design

Design model

Parallel

Treatments tested in this trial

  • timing of cleansing and procedure

    Other intervention

    we are altering the timing of colonoscopy and cleansing for colonoscopy for patients with diabetes.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control Group (Standard Preparation)Active comparator 1 intervention
Group B: Diabetes-Specific Protocol GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During colonoscopy

Secondary outcomes

1

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.

Time frame
Pericolonoscopy period
2

Patient Rating

Patient-reported ratings of convenience, tolerability and adverse events associated with the preparation protocol.

Time frame
Pericolonoscopy period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen's University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: