Research on Safety and Efficacy of Continuous Glucose Monitoring in Type 1 Diabetes Children (RoSEC)

• Register: ANZCTR
• Last refreshed on: 20 August 2018
• Main ID: ACTRN12618000860268
• Date of registration: 22/05/2018
• Prospective Registration: Yes
• Primary sponsor: Hospital Universiti Sains Malaysia
• Public title: Research on Safety and Efficacy of Continuous Glucose Monitoring in Type 1 Diabetes Children (RoSEC)
• Scientific title: Continuous Subcutaneous Glucose Monitoring vs Self-Monitoring Blood Glucose in Paediatric Patients with Type 1 Diabetes (RoSEC): A Randomized Controlled Trial
• Date of first enrolment: 10/07/2018
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12618000860268.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

The subjects will be divided into intervention arm and control arm with the ratio of 1:1. The intervention is the adjustment of daily insulin dose based on glucose level over 1 week measured using Continuous Glucose Monitoring Device (CGMS)..
CGMS device is a small device placed on the abdomen equipped with a small plastic sensor needle that will be placed under the skin. The device will continuously records the body interstitial fluid glucose level for one week. Study had found that the interstitial fluid glucose level correlates well with the capillary glucose level monitored via finger skin prick. (Thennadil et al, 2001). The device will be placed by a trained nurse and information on the handling and care of the device and its possible complication will be explained in an outpatient appointment. The data will be downloaded using a computer software by a trained research assistant and reviewed retrospectively by a paediatric endocrinologist.
All subjects in both arm will be wearing a CGMS device on their abdomen for 1 week at the beginning of the study. However, the data is made blinded to the subject. In the same time, all subjects will need to continue their usual 4 times per day capillary blood glucose monitoring. Subjects in the intervention arm will have their insulin dose for the next 12 week adjusted according to the data from the CGMS device. This will take into consideration the frequency of hypoglycemia and hyperglycemia episodes.
The device will be worn twice during the whole study period i.e.at the beginning of the study and at week 12. HbA1C level and the number of hypoglycemic episode per week will be measured at baseline, at the end of week 12 and at the end of the study to determine the efficacy and the safety of the CGMS device in improving the glycemic control.