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Trial record 3 of 5 for:    15951574 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204657
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Shireene Vethakkan, University of Malaya

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gestational Diabetes Mellitus
Intervention Device: Continuous Glucose Monitoring System
Enrollment 50
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Continuous Glucose Monitoring System Control
Hide Arm/Group Description

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

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.
Period Title: Overall Study
Started 32 25
Completed 25 25
Not Completed 7 0
Arm/Group Title Continuous Glucose Monitoring System Control Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
32.80  (4.53) 32.6  (4.93) 32.7  (4.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
25
 100.0%
25
 100.0%
50
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malaysia Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Glycemic Control by Measurement of HbA1c
Hide Description [Not Specified]
Time Frame From 28 weeks until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Glucose Monitoring System Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: mean percentage
5.17  (0.41) 5.57  (0.57)
2.Secondary Outcome
Title Hypoglycemia
Hide Description [Not Specified]
Time Frame 28 weeks until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Glucose Monitoring System Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: episodes per patient
8.0
(3 to 14)
4.0
(1 to 6.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous Glucose Monitoring System Control
Hide Arm/Group Description

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

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.
All-Cause Mortality
Continuous Glucose Monitoring System Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Continuous Glucose Monitoring System Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Glucose Monitoring System Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Sharmila SP
Organization: University Malaya Medical Centre
Phone: 60379492299
EMail: sharmsp13@gmail.com
Publications:
Layout table for additonal information
Responsible Party: Shireene Vethakkan, University of Malaya
ClinicalTrials.gov Identifier: NCT02204657     History of Changes
Other Study ID Numbers: 961.7
PPUM/QSU/300-04/11 ( Other Identifier: University Malaya Medical Centre, Malaysia )
First Submitted: July 28, 2014
First Posted: July 30, 2014
Results First Submitted: June 23, 2016
Results First Posted: August 5, 2016
Last Update Posted: August 5, 2016