Trial Outcomes & Findings for The Effect of Continuous Glucose Monitoring on Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus (NCT NCT02204657)

NCT ID: NCT02204657

Last Updated: 2016-08-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: From 28 weeks until delivery
• Results posted on: 2016-08-05

Participant Flow

50 women with insulin-requiring gestational diabetes enrolled from the University of Malaya Medical CentreAntenatal Clinic between April 2013 to April 2015. Women with overt diabetes or pregestational diabetes were excluded.

Participant milestones

Measure	Continuous Glucose Monitoring System Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results. Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings	Control Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
Overall Study STARTED	32	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Continuous Glucose Monitoring on Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus

Baseline characteristics by cohort

Measure	Continuous Glucose Monitoring System n=25 Participants Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results. Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings	Control n=25 Participants Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.80 years STANDARD_DEVIATION 4.53 • n=5 Participants	32.6 years STANDARD_DEVIATION 4.93 • n=7 Participants	32.7 years STANDARD_DEVIATION 4.73 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Malaysia	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: From 28 weeks until delivery

Outcome measures

Measure	Continuous Glucose Monitoring System n=25 Participants Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results. Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings	Control n=25 Participants Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
Glycemic Control by Measurement of HbA1c	5.17 mean percentage Standard Deviation 0.41	5.57 mean percentage Standard Deviation 0.57

SECONDARY outcome

Timeframe: 28 weeks until delivery

Outcome measures

Measure	Continuous Glucose Monitoring System n=25 Participants Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results. Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings	Control n=25 Participants Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
Hypoglycemia	8.0 episodes per patient Interval 3.0 to 14.0	4.0 episodes per patient Interval 1.0 to 6.5

Adverse Events

Continuous Glucose Monitoring System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr Sharmila SP

University Malaya Medical Centre

Phone: 60379492299

Email: sharmsp13@gmail.com

Results disclosure agreements

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