Gestational Diabetes Mellitus
Conditions
Keywords
Continuous glucose monitoring in GDM
Brief summary
The purpose of this study is to determine if professional Continuous glucose monitoring improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes Mellitus
Detailed description
1. OBJECTIVES 1. To determine if professional CGM improves glycemic control with less hypoglycaemia in insulin- requiring GDM 2. To determine if professional CGM use alters management of insulin-requiring GDM 3. To determine if professional CGM improves pregnancy outcomes in insulin-requiring GDM. 4. To determine patient attitudes toward CGMS. 2. HYPOTHESES 1. Professional CGMS improves glycaemic control in women with insulin-requiring GDM with less hypoglycaemia 2. Professional CGM use will alter management of insulin-requiring GDM 3. Professional CGMS will reduce perinatal morbidity and mortality in patients with insulin- requiring GDM 4. Third trimester CGMS parameters will correlate better with perinatal outcomes compared with conventional measures of glycaemic control in pregnancy i.e. fructosamine/ A1c/ FBS/ 2hrs PP glucose STUDY DESIGN * This is a prospective, open-label, randomized controlled trial. We plan to recruit 80 women with gestational diabetes at 28 weeks gestation or less from the UMMC antenatal clinic. These women should be insulin-naïve but require insulin therapy. 40 subjects (Group 1) will be selected to undergo professional CGM at weeks 28, 32, and week 36 and another 40 subjects individually matched with regards, to age, baseline A1c, BMI will be recruited to undergo usual antenatal care without CGMS (Group 2). The CGMS data will be uploaded and reviewed at weeks 29, 33, and 37 and changes made to the therapeutic regimen as required by the endocrinologist. All mothers will be required to measure their glucose levels at 7 standardized points in a day daily. These glucose readings will be recorded in a diary together with a food log. All subjects will also be required to keep a hypoglycaemia diary. * The primary outcomes will be glycaemic control in the third trimester and maternal hypoglycaemia. We also plan to assess changes to management made by the endocrinologist based on the additional information on glycemic control obtained from professional CGM use. We also plan to compare hypoglycaemia and hyperglycaemia detection rates using the CGMS and fingerstick methods of glucose evaluation. Patient satisfaction in both groups will also be assessed. Written and informed consent will be obtained in accordance with the principles of the Helsinki Declaration
Interventions
DEVICEContinuous 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
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women with gestational diabetes * aged \>18 years * less than or equal to 28 weeks gestation of pregnancy * singleton pregnancy * insulin naive , but requiring insulin therapy
Exclusion criteria
* pregestational type 1 or 2 diabetes mellitus * newly diagnosed overt diabetes in pregnancy ( HbA1c \> 6.5) * hypothyroidism * Cushing's syndrome/ using exogenous steroids * chronic infection ( HIV, Hepatitis B/C, Tuberculosis) * any active chronic systemic disease ( except essential hypertension) * assisted conception * pregnancies with fetal anomalies / where imminent or preterm delivery is likely because of maternal disease ( besides gestational diabetes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic Control by Measurement of HbA1c | From 28 weeks until delivery |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia | 28 weeks until delivery |
Countries
Malaysia
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Control | Continuous Glucose Monitoring System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 32.6 years STANDARD_DEVIATION 4.93 | 32.80 years STANDARD_DEVIATION 4.53 | 32.7 years STANDARD_DEVIATION 4.73 |
| Region of Enrollment Malaysia | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Glycemic Control by Measurement of HbA1c
Time frame: From 28 weeks until delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring System | Glycemic Control by Measurement of HbA1c | 5.17 mean percentage | Standard Deviation 0.41 |
| Control | Glycemic Control by Measurement of HbA1c | 5.57 mean percentage | Standard Deviation 0.57 |
Secondary
Hypoglycemia
Time frame: 28 weeks until delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Monitoring System | Hypoglycemia | 8.0 episodes per patient |
| Control | Hypoglycemia | 4.0 episodes per patient |