Integrated Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy in Comparison With OGTT (I-CHAP)
Phase: NA
Conditions: Gestational Diabetes, Glucose Metabolism Disorders, Metabolic Disease
Sponsor: KK Women's and Children's Hospital

 
 
 
Page 1 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
 
 
 
PARTICIPANT INFORMATION SHEET AND CONSENT FORM 
 
You are being invited to participate in a research study. Your participation in this study is 
entirely voluntary. Before you take part in this research study, the study must be explained to 
you and you must be given the chance to ask questions. Your questions will be answered 
clearly and to your satisfaction. Please read carefully the information provided here. If you 
agree to participate, please sign the consent form. You will be given a copy of this document. 
 
 
STUDY INFORMATION 
 
Protocol Title: 
Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in 
comparison with OGTT (I-CHAP) 
 
This research study is recruiting at the following SingHealth institution(s). Please note that the 
word “SingHealth” refers to the institution where you are recruited into the study. 
 
KK Women's and Children's Hospital 
 
 
Principal Investigator:  
 
 
 
 
Dr Quah Phaik Ling 
Senior Research Fellow  
Department of Obstetrics & Gynaecology 
Tel: 97732543 
Institution Mainline: +65 6394 1099 
 
 
PURPOSE OF THE RESEARCH STUDY 
 
The purpose of this study is to contribute new knowledge by examining the use of electronic 
devices that you can wear on your body. More specifically, we want to know if  sensors you 
wear on your body that can track your sugar level throughout the day called the continuous 
glucose monitor (CGM)can improve patient care and be a potential replacement to the routine 
oral glucose tolerance test (OGTT). All pregnant women undergo the OGTT for the diagnosis 
of diabetes during pregnancy that we term gestational diabetes mellitus (GDM). Before you 
take part in this research study, the study must be explained to you, and you must be given 
the chance to ask questions. Please read carefully the information provided here. If you agree 
to participate, please sign the informed consent form. You will be given a copy of this document 
to take home with you. 
 
You were selected as a possible participant in this study because you are pregnant and 
attending KK Women’s and Children’s Hospital for antenatal consultation. You have to be 
pregnant and have not undergone your OGTT. 

 
 
 
Page 2 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
The study’s main aim is to establish much needed preliminary evidence in our Asian 
population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. 
 
This study targets to recruit 80 participants from KK Women’s and Children’s Hospital.  
 
 
STUDY PROCEDURES & YOUR RESPONSIBILITIES IN THIS STUDY 
 
If you agree to take part in this study, a consent form will be signed. You will also receive 
education from the study team on how to apply the Dexcom continuous glucose monitoring 
(CGM) device on your own 3 days before your scheduled OGTT. At the end of the 10-day 
wear, peel off the sensor like a plaster and dispose normally. You will also be given a 
glucose data receiver which you must carry with you for the 10-day duration of your CGM 
wear. 
Figure 1 shows you how the CGM device looks like, and Figure 2 shows you how it will be 
worn on the back of your upper arm.  
The application of this sensor is painless and will only take a few seconds.  
At your next routine antenatal clinic visit, you must return the glucose data receiver to the 
study team before the study team can provide you a copy of your glucose data for your 
reference.  
 
Data obtained during this study will be stored and used only for the purposes of this study.   
These data will not be used for future research.  
YOUR RESPONSIBILITIES IN THIS STUDY 
If you agree to participate in this study, you should: 
 
 
Put on the continuous glucose monitoring (CGM) 3 days before your OGTT 
 
Remove the sensor only after your 10-day wear 
 
Return the glucose data receiver to the research team at your next antenatal clinic visit 
 
Complete the questionnaires provided at your next antenatal clinic visit which will take 
approximately 10 minutes 
 
The study involves the following: 
 
Study device: 
Application of Dexcom CGM sensors 
The study team will educate you on how and when to apply the G6 Dexcom CGM sensor on 
either your right or left arm once the consent form has been signed, and once you have been 
recruited as a participant of the study. You will be advised on when to apply the CGM sensors, 
and to complete a 10-day wear-time.  

 
 
 
Page 3 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
There are no safety risks since the sensor’s battery is waterproof. You are free to take a 
shower or swim with it anytime. Such device has been approved by Singapore Health 
Science Authority (HSA).  
Glucose data 
The study team members will be downloading your glucose data to the Dexcom CLARITY 
online website and your data will be stored temporarily in a secure Cloud. Your patient 
information will be de-identified and only your Subject ID will be used to tag your glucose data. 
Only the study team will have access to this data and the data will be deleted when your 
account is no longer active.  
Baseline demographic information 
We will be collecting some baseline demographic information from you, but no personal 
identifiers. 
 
Questionnaires 
At your next routine antenatal clinic visit, you will be asked to self-report your OGTT date, 
timing of the first blood draw, GDM diagnosis and treatment received. You will also be given 
a feedback survey questionnaire to fill in. 
 
Maternal obstetrics and neonatal outcomes 
Your maternal obstetrics outcomes and neonatal birth outcomes will be retrieved from the 
hospital medical notes.  
 
 
 
Figure 1: The Dexcom G6 continuous glucose monitoring (CGM) sensor. The Dexcom G6 
measures 70mm X 40mm X 10mm, and weighs 11.9 grams.  
 
 
 
 
 
Figure 2: The Dexcom G6 sensor placement on the upper arm 
 
 
 
 

 
 
 
Page 4 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
 
 
 
WHAT IS NOT STANDARD CARE OR IS EXPERIMENTAL IN THIS STUDY 
 
The glucose monitoring sensor is not part of routine assessment and is not meant for 
diagnostic or screening purposes. We hope that your participation will help us to determine 
whether the sensor is well tolerable and acceptable in pregnant women. 
In this study, the introduction of the use of the Dexcom G6 CGM is being performed for the 
purposes of the research and are not part of your routine care.  
 
 
POSSIBLE RISKS, DISCOMFORTS OR INCONVENIENCES 
 
There will be minimal risks because the continuous glucose monitoring system has been 
tested to be minimally invasive and has low irritability to pregnant subjects. There will not be 
any possible risks on the sensor’s battery and it is water proof. The participants wearing this 
device is free to take a shower or swim with it anytime. However, local bruises and skin rashes 
might be possible even though low in likelihood, and it is not widely reported in previous studies. 
 
Questionnaires/ surveys/ interviews: 
Some of the questions might make you feel uncomfortable or upset. You may refuse to answer 
any of the questions and/or take a break at any time during the study. 
 
POTENTIAL BENEFITS 
If you participate in this study you may reasonably expect to benefit from the study device as 
this project is the first to look at a possible ways to incorporate the use of the CGM technology 
into pregnant patient care for diagnosing GDM. You will also be receiving a copy of your 
glucose data from the 10-day wear. 
 
 
ALTERNATIVE IF YOU DO NOT PARTICIPATE IN THE STUDY 
 
If you choose not to take part in this study, the alternative is to have what is considered 
standard care for your condition. In our institution, the standard care involves your routine 
antenatal visits at KKH. 
 
 
COSTS & PAYMENTS IF PARTICIPATING IN THIS STUDY 
 
You will be reimbursed for your time, inconvenience and transportation costs as follows by 
the study team:  
• 
If you complete the study and return the glucose receive to the study team, you will 
receive SGD50 for the first baseline visit and the second clinic visit.  
• 
You will be receiving SGD100 in total for the completion of both visits 
 
The Dexcom CGM sensors will be provided to you at no cost.  

 
 
 
Page 5 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
The cost of your usual medical care (procedures, medications and doctor visits) will continue 
to be billed to you. 
 
INCIDENTAL FINDINGS 
 
“Incidental findings” are findings that have potential health or reproductive importance to a 
participant like you and are discovered in the course of conducting the study, but are unrelated 
to the purposes, objectives or variables of the study. These findings may cause you to feel 
anxious and may affect your current or future life and/or health insurance coverage. Examples 
of potential incidental findings that may be discovered during the course of this study may 
include but are not limited to (i.e. any abnormality that we did not expect to see in this study 
or unrelated to the purpose of this study), 
 
It is possible that incidental findings may be detected or suspected in the course of conducting 
the study. As this is research and there is no intention to perform medical diagnosis, the 
medical significance of the incidental finding may not be clear. Hence, there is no notification 
for incidental findings. 
Please note that the readings from the CGM devices may differ from that of the OGTT. This 
is because the CGM samples glucose from the interstitial fluid, and not the blood which might 
account for minor discrepancy in the values. However, we do expect the glucose readings 
from both the CGM and the OGTT to be very similar in terms of the trends. 
 
 
PARTICIPANT’S RIGHTS 
 
Your participation in this study is entirely voluntary. You have a right to ask questions, which 
the study team will do their best to answer clearly and to your satisfaction. 
 
In the event of any new information becoming available that may be relevant to your 
willingness to continue in this study, you (or your legal representative, if relevant) will be 
informed in a timely manner by the Principal Investigator or his/her representative and will be 
contacted for further consent if required. 
 
WITHDRAWAL FROM STUDY 
 
You are free to withdraw your consent and discontinue your participation in the study at any 
time, without your medical care being affected. If you decide to stop taking part in this study, 
you should tell the Principal Investigator. 
 
If you withdraw from the study, all study procedures will be discontinued. However, the data 
that have been collected until the time of your withdrawal will be kept and analyzed. The 
reason is to enable a complete and comprehensive evaluation of the study. 
 
The Principal Investigator of this study may stop your participation in the study at any time for 
one or more of the following reasons:  
• 
Failure to follow the instructions of the Principal Investigator and/or study staff.  
• 
You are strongly against wearing the glucose monitoring sensor due to severe 
skin irritation or mentally stress.  
• 
The study is cancelled.  
 

 
 
 
Page 6 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
 
RESEARCH RELATED INJURY AND COMPENSATION 
 
If you follow the directions of the Principal Investigator of this research study and you are 
injured due to the medical device given under the plan for the research study, our institution 
will provide you with the appropriate medical treatment. 
 
Payment for management of the normally expected consequences of your treatment (i.e. 
consequences of your treatment which are not caused by your participation in the research 
study) will not be provided.   
  
You still have all your legal rights. Nothing said here about treatment or compensation in any 
way alters your right to recover damages where you can prove negligence. 
 
 
CONFIDENTIALITY OF STUDY AND MEDICAL RECORDS 
 
Your participation in this study will involve the collection of Personal Data. “Personal Data” 
means data about you which makes you identifiable (i) from such data or (ii) from that data 
and other information which an organisation has or likely to have access. Examples of 
personal data include name, national registration identity card (NRIC), nationality, passport 
information, date of birth, and telephone number.  
 
Personal Data collected for this study will be kept confidential and stored in Singapore. Your 
study records and medical records (if applicable), to the extent required by the applicable laws 
and regulations, will not be made publicly available.  To protect your identity, your Personal 
Data will be labelled with a unique code. The code will be used in place of your name and 
other information that directly and easily identifies you. The study team will keep a separate 
file that links your code to your Personal Data. This will be kept in a safe place with restricted 
access. In the event of any publication regarding this study, your identity will remain 
confidential.  
 
However, the monitor(s), the auditor(s), the Institutional Review Board, and the regulatory 
authority(ies) will be granted direct access to your original medical records (if applicable) and 
study records to verify study procedures and data, without making any of your information 
public.  
 
By signing the Consent Form, you consent to (i) the collection, access to, use and storage of 
your Personal Data by SingHealth, and (ii) the disclosure of such Personal Data to our 
authorised service providers and relevant third parties as mentioned above. To the fullest 
extent permitted by applicable law, under no circumstances will SingHealth and/or its affiliates 
be liable for any direct, indirect, incidental, special or consequential loss or damages arising 
out of any data breach event.  
  
All data collected in this study are the property of SingHealth and will be used for the purpose 
of this research study only. 
By participating in this research study, you are confirming that you have read, understood and 
consent to the SingHealth Data Protection Policy, the full version of which is available at 
www.singhealth.com.sg/pdpa. 
 

 
 
 
Page 7 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
 
WHO HAS REVIEWED THE STUDY 
 
This study has been reviewed by the SingHealth Centralised Institutional Review Board for 
ethics approval.  
 
If you have questions about your rights as a participant, you can call the SingHealth 
Centralised Institutional Review Board at 8126 3660 during office hours (8:30 am to 5:30pm). 
 
 
WHO TO CONTACT IF YOU HAVE QUESTIONS REGARDING THE STUDY  
 
If you have questions about this research study or in the case of any injuries during the course 
of this study, you may contact your study doctor, the Principal Investigator listed under STUDY 
INFORMATION section, at the beginning of this document.   
 
If you have any feedback about this research study, you may contact the Principal Investigator 
or the SingHealth Centralised Institutional Review Board. 
 
 

 
 
 
Page 8 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
CONSENT FORM FOR RESEARCH STUDY 
 
Protocol Title: 
Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in 
comparison with OGTT (I-CHAP) 
 
Declaration by Research Participant 
(i) I agree to participate in the research study as described and, on the terms, set out in the 
Participant Information Sheet. The nature, risks and benefits of the study have been explained 
clearly to me and I fully understand them. 
 
(ii) I understand the purpose and procedures of this study. I have been given the Participant 
Information Sheet and the opportunity to discuss and ask questions about this study and am 
satisfied with the information provided to me.  
 
 
(v) I understand that my participation is voluntary and that I am free to withdraw at any time, 
without giving any reasons and without my medical care being affected.  
 
(vi) By participating in this research study, I confirm that I have read, understood and consent 
to the SingHealth Data Protection Policy.  
 
 
____________________      ____________________________        ______________ 
 Name of participant               Signature/Thumbprint (Right / Left)      Date of signing 
 
 
To be completed by parent / legal guardian / legal representative, where applicable 
 
I hereby give consent for _________________________ (Name of Participant) to participate 
in the research study. The nature, risks and benefits of the study have been explained clearly 
to me and I fully understand them. 
 
I confirm that I have read, understood and consent to the SingHealth Data Protection Policy. 
 
 
____________________      ____________________________        ______________ 
 Name of participant’s             Signature/Thumbprint (Right / Left)      Date of signing 
 parent/ legal guardian/  
 legal representative 
 
 
To be completed by translator, if required 
 
The study has been explained to the participant/ legal representative in  
 
________________________________ by _____________________________________. 
           Language                                                           Name of translator 
 
 
To be completed by witness, where applicable 

 
 
 
Page 9 of 9 
Informed Consent Document: Version 1.0 dated 20022024 
Restricted, Sensitive (Normal)  
 
I, the undersigned, certify that: 
• 
I am 21 years of age or older. 
• 
To the best of my knowledge, the participant or the participant’s legal representative 
signing this informed consent form had the study fully explained to him/her in a 
language understood by him/ her and clearly understands the nature, risks and 
benefits of the participant’s participation in the study. 
• 
I have taken reasonable steps to ascertain the identity of the participant or the 
participant’s legal representative giving the consent. 
• 
I have taken reasonable steps to ascertain that the consent has been given voluntarily 
without any coercion or intimidation. 
 
Witnessed by: ________________________________ 
___________________ 
 
                       Name of witness 
 
   
 Date of signing 
 
 
 
 
________________________________ 
 
 
 
          Signature of witness 
 
 
   
1. An impartial witness (who is 21 years of age or older, has mental capacity, who is independent of the research study, and 
cannot be unfairly influenced by people involved with the research study) should be present during the entire informed consent 
discussion if a participant or the participant’s legal representative is unable to read, and/or sign and date on the consent form (i.e. 
using the participant’s or legal representative’s thumbprint). After the written consent form and any written information to be 
provided to participant is read and explained to the participant or the participant’s legal representative, and after the participant 
or the participant’s legal representative has orally consented to the participant’s participation in the study and, if capable of doing 
so, has signed and personally dated the consent form, the witness should sign and personally date the consent form. This is 
applicable for Clinical Trials regulated by HSA and Human Biomedical Research under the HBRA. 
 
2. For HBRA studies, the witness may be a member of the team carrying out the research only if a participant or the participant’s 
legal representative is able to read, sign and date on the consent form.   
 
 
Investigator’s Statement 
 
I, the undersigned, certify to the best of my knowledge that the participant/ participant’s legal 
representative signing this consent form had the study fully explained to him/her and clearly 
understands the nature, risks and benefits of the participant’s participation in the study. 
 
 
________________________       _______________________ 
________________ 
 Name of Investigator/  
         Signature 
 
 
 Date  
 Person obtaining consent