Trial Outcomes & Findings for Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation (NCT NCT03109951)

NCT ID: NCT03109951

Last Updated: 2020-03-20

Results Overview

Count of patients with Serum glucose levels \< 70mg/dL or \>250mg/dL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 187 participants
• Primary outcome timeframe: 30 minutes before colonoscopy
• Results posted on: 2020-03-20

Participant Flow

None noted as this was a single-arm study.

Participant milestones

Measure	Diabetes Group Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
Overall Study STARTED	187
Overall Study COMPLETED	187
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

Baseline characteristics by cohort

Measure	Diabetes Group n=187 Participants Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
Age, Continuous	59.5 years STANDARD_DEVIATION 9.7 • n=93 Participants
Sex: Female, Male Female	70 Participants n=93 Participants
Sex: Female, Male Male	117 Participants n=93 Participants
Race/Ethnicity, Customized Korean Ethnicity	187 Participants n=93 Participants
Region of Enrollment South Korea	187 participants n=93 Participants
Fasting glucose level	135.9 mg/dL STANDARD_DEVIATION 33.1 • n=93 Participants
Number of polyps	1.3 polyps STANDARD_DEVIATION 2.0 • n=93 Participants
Number of adenomas	1.1 adenomas STANDARD_DEVIATION 1.8 • n=93 Participants
Number of advanced adenomas	0.2 advanced adenomas STANDARD_DEVIATION 0.5 • n=93 Participants
Diabetes history	7.3 years STANDARD_DEVIATION 7.9 • n=93 Participants
Fasting period	19.2 hours STANDARD_DEVIATION 4.4 • n=93 Participants

PRIMARY outcome

Timeframe: 30 minutes before colonoscopy

Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL

Outcome measures

Measure	Diabetes Group n=187 Participants Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
Abnormal Glucose Levels After Colonoscopic Preparation Number of hyperglycemia subjects	2 Participants
Abnormal Glucose Levels After Colonoscopic Preparation Number of subjects without hypo or hyperglycemia	185 Participants
Abnormal Glucose Levels After Colonoscopic Preparation Number of hypoglycemia subjects	0 Participants

SECONDARY outcome

Timeframe: 30 minutes before colonoscopy

Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them.

Outcome measures

Measure	Diabetes Group n=187 Participants Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
Cognition of Hypoglycemic Symptoms	96 Participants

SECONDARY outcome

Timeframe: From colonoscopy preparation beginning to day 1 after colonoscopy

Population: 4 subjects reported hypoglycemia symptoms. All recovered through self-treatment (e.g. drinking juice or taking candy).

Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms

Outcome measures

Measure	Diabetes Group n=187 Participants Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms	4 Participants

Adverse Events

Diabetes Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Myong Ki Baeg

International St. Mary's Hospital, Catholic Kwandong University

Phone: 82-10-6391-9010

Email: baegmk@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place