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Trial registered on ANZCTR


Registration number
ACTRN12618000860268
Ethics application status
Approved
Date submitted
14/05/2018
Date registered
22/05/2018
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 294829 0
None
Universal Trial Number (UTN)
U1111-1213-6834
Trial acronym
RoSEC (Research on Safety and Efficacy of Continuous Glucose Monitoring)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 307773 0
Condition category
Condition code
Metabolic and Endocrine 306816 306816 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 301141 0
Treatment: Devices
Comparator / control treatment
The control arm consist of subjects who has been blindly allocated as control group. These subjects will also wear the CGMS device for 1 week at the beginning and week 12 of the study. However, the data will not be used to adjust the insulin dose but rather as a blinding method. They will continuously check their capillary blood glucose level 4 times per day. The value of this intermittent glucose monitoring will be used to determine the insulin dose for the next 12 weeks.
HbA1C level and the number of hypoglycemic episode per week recorded by the CGMS device 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.

Control group
Active

Outcomes
Primary outcome [1] 305849 0
Serum HbA1C level
Serum HbA1c is measured using ion exchange high performance liquid chromatography technique at HUSM endocrine lab. The machine is calibrated every 2 weekly. The machine runs in batches every 2 to 3 days where the results will be available from the online lab results application accessible only to clinicians.
Timepoint [1] 305849 0
Baseline
End of week 12
End of week 24
Secondary outcome [1] 346761 0
Number of hypoglycemic episodes per week defined as glucose level of 3.6 mmol/L (65 mg/dL)
This represent the safety outcome. Study has shown that the use of CGMS is associated with increase in the duration of hypoglycemia (Yates, Hasnat Milton et al. 2006).
The number of hypoglycemic episodes per week is measured by counting the number of symptomatic and asymptomatic hypoglycemia in a week while wearing the CGMS device as recorded by patient in their record book (in control group) or detected by the CGMS device (in intervention group)
Timepoint [1] 346761 0
Baseline
End of week 12
End of week 24

Eligibility
Key inclusion criteria
1. children and adolescent diagnosed with T1DM and were followed up at HUSM Kubang Kerian, Kelantan.
2. Diagnosed with T1DM for at least 12 months
3. On intensive Regimen which are three or more daily insulin injections
4. Baseline HbA1c > 7.6%
Minimum age
7 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other type of Diabetes namely Type 2 Diabetes, Maturity-onset diabetes in youth
(MODY) and Neonatal Diabetes.
2. Patient on conventional insulin regimen which are one to two times a day injection of self-mixed or premixed insulin
3. Syndromic or dysmorphic patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation procedure will be done by a dedicated research assistant not involved in the data collection and analysis. Interventionist (endocrinologist) and data collector/analyst will not involve in the allocation procedure. The allocation process will be done at a designated room at paediatric clinic coordinated by a dedicated research nurse. Subjects will have to pick up an envelope containing card numbered 1-50. The card will be placed in between 2 black cards in a sealed envelope to ensure no one will be able to identify the number by looking through light source. Patient identification will be written on the envelope and kept away into a file placed in a locked cabinet. All the envelopes will be open by the research nurse away from anyone else. The subject identification and research number will be recorded in a subject database sheet in a file kept by clinic sister in a locked cabinet. Only research nurse and clinic sister have access to the database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated by a research nurse using website https://www.randomizer.org/ Two allocation sequences will be generated by the website. Each sequence will either be the intervention or control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be entered and analysed using SPSS version 24. The demographic and numerical data were presented by mean (SD) and median (IQR) according to data distribution. The categorical data were expressed as number and percentage.
Repeated measure ANCOVA will be used to measure the mean difference of HbA1c between groups, within groups and between-within groups.
Independent sample t-test will be used analyzed the mean number of hypoglycemic episodes per week between the groups if the outcome variable is normally distributed.
Paired t-test will be used to compare baseline mean number of hypoglycemic episodes per week and the outcome post intervention within each group. If the data follows non-parametric distribution, Wilcoxon Signed-Ranks test of the median difference will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10392 0
Malaysia
State/province [1] 10392 0
Kelantan

Funding & Sponsors
Funding source category [1] 299424 0
Charities/Societies/Foundations
Name [1] 299424 0
Malaysia Endocrine and Metabolic Society
Address [1] 299424 0
B-26-07, Suasana Sentral Loft Condominium (Tower B),
Jalan Stesen Sentral 5, KL Sentral,
50470 Kuala Lumpur
Malaysia
Country [1] 299424 0
Malaysia
Primary sponsor type
Hospital
Name
Hospital Universiti Sains Malaysia
Address
Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan
Country
Malaysia
Secondary sponsor category [1] 298742 0
None
Name [1] 298742 0
Address [1] 298742 0
Country [1] 298742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300325 0
Human Research Ethics Committee USM (HREC)
Ethics committee address [1] 300325 0
Universiti Sains Malaysia
Kampus Kesihatan
16150 Kubang Kerian, Kelantan,
Ethics committee country [1] 300325 0
Malaysia
Date submitted for ethics approval [1] 300325 0
24/10/2017
Approval date [1] 300325 0
16/11/2017
Ethics approval number [1] 300325 0
17080378

Summary
Brief summary
The RoSEC study is a single center, randomized, double-blind, and parallel-group controlled trial with equal randomization (allocation ratio 1:1) conducted at Hospital Universiti Sains Malaysia. This study will involved children aged 7 to 18 with Type 1 Diabetes Mellitus on intensive Insulin regime at least 3 times injection per day. With the hypothesis that there is a significant difference in HbA1c and number of hypoglycemic episodes per week when the data of CGMS is used to fine-tune the diabetic management as compared to self-monitoring blood glucose (SMBG), this study aims to determine the efficacy of continuous glucose monitoring system (CGMS) compared to conventional intermittent blood glucose monitoring (SMBG) in reducing the HbA1C level without compromising the safety of patient by increasing the frequency of hypoglycemia per week.
In this study, subjects will be randomly assigned into one of two arms, the intervention and control arm. All subjects will be wearing the CGMS device for one week at the beginning of the study, at week 12 and at week 24 of the study period. On top of that, each subject will also need to check their capillary glucose via finger prick 4 times daily throughout the study period.
Subjects in the intervention arm will have their insulin dose adjusted based on the continuous glucose level measured by the CGMS while the subjects in the control arm will have their insulin dose adjusted based on their own SMBG charting. HbA1c level and number of hypoglycemia per week will be measured at the beginning, week 12 and end of week 24 of the study to determine the efficacy and safety of CGMS compared to SMBG.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83302 0
Dr Suhaimi Hussain
Address 83302 0
Paediatric Department, Hospital University Sains Malaysia
Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 83302 0
Malaysia
Phone 83302 0
+6097676947
Fax 83302 0
Email 83302 0
hsuhaimi@usm.my
Contact person for public queries
Name 83303 0
Dr Muhd Alwi, Muhd Helmi
Address 83303 0
Department of Paediatric, Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 83303 0
Malaysia
Phone 83303 0
+601111333010
Fax 83303 0
Email 83303 0
muhdalwi@iium.edu.my
Contact person for scientific queries
Name 83304 0
Dr Muhd Alwi, Muhd Helmi
Address 83304 0
Department of Paediatric, Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab II, Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 83304 0
Malaysia
Phone 83304 0
+601111333010
Fax 83304 0
Email 83304 0
muhdalwi@iium.edu.my

No information has been provided regarding IPD availability
Summary results
No Results