Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
Phase: NA
Conditions: Type 1 Diabetes Mellitus With Hypoglycemia, Impaired Awareness of Hypoglycemia, Type1diabetes
Sponsor: Imperial College London

 
I HART CGM 
Protocol v2.0 
30th August 2015 
 
 
I HART CGM 
 
 
 
 
Impact on Hypoglycaemia Awareness of Real Time CGM and 
Intermittent Continuous Glucose Data  
 
 
 
 
V2.0 30th August 2015 
 
 
 
 
MAIN SPONSOR: Imperial College London 
FUNDERS: Dexcom 
STUDY COORDINATION CENTRE: Imperial College London 
NRES reference: 15/LO/1679 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
Dr Nick Oliver 
30/August/ 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
I HART CGM 
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30th August 2015 
Study Management Group 
 
Chief Investigator: Dr Nick Oliver 
 
Co-investigators: Dr Ahmed El-Laboudi - Dr Monika Reddy 
 
Statistician: Dr Ian Godsland 
 
Study Management: Narvada Jugnee 
 
 
Clinical Queries 
 
Clinical queries should be directed to Dr Nick Oliver who will direct the query to the 
appropriate person 
 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further information 
regarding the sponsorship conditions, please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London 
5th Floor Lab Block 
Charing Cross Hospital 
Fulham Palace Road 
London W6 8RF 
Tel: 0203 311 0204 
Fax: 0203 311 0203 
 
 
Funder 
Dexcom 
 
 
 
 
This protocol describes the study and provides information about procedures for entering participants.  
Every care was taken in its drafting, but corrections or amendments may be necessary. These will be 
circulated to investigators in the study.  Problems relating to this study should be referred, in the first 
instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance Framework for Health 
and Social Care (2nd edition). It will be conducted in compliance with the protocol, the Data Protection 
Act and other regulatory requirements as appropriate.  
 
 
 

 
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Table of Contents 
1. 
INTRODUCTION 
6 
1.1 BACKGROUND 
6 
2.  STUDY OBJECTIVES 
7 
3.  STUDY DESIGN 
7 
3.1 STUDY OUTCOME MEASURES 
ERROR! BOOKMARK NOT DEFINED. 
4. 
PARTICIPANT ENTRY 
7 
4.1 PRE-REGISTRATION EVALUATIONS 
7 
4.2 INCLUSION CRITERIA 
8 
4.3 EXCLUSION CRITERIA 
8 
4.4 WITHDRAWAL CRITERIA 
8 
5. 
ADVERSE EVENTS 
8 
5.1 DEFINITIONS 
8 
5.3 REPORTING PROCEDURES 
8 
6. 
ASSESSMENT AND FOLLOW-UP 
9 
7. 
STATISTICS AND DATA ANALYSIS 
11 
8. 
REGULATORY ISSUES 
11 
8.1 ETHICS APPROVAL 
11 
8.2 CONSENT 
11 
8.3 CONFIDENTIALITY 
11 
8.4 INDEMNITY 
12 
8.5 SPONSOR 
12 
8.6 FUNDING 
12 
8.7 AUDITS AND INSPECTIONS 
12 
9. 
STUDY MANAGEMENT 
12 
11. 
PUBLICATION POLICY 
12 
12. 
REFERENCES 
12 
EXAMPLE APPENDICES 
13 
APPENDIX 1. 
SUMMARY OF INVESTIGATIONS, TREATMENT AND ASSESSMENTS 
14 
 
 
 

 
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GLOSSARY OF ABBREVIATIONS 
CGM 
Continuous glucose monitoring 
T1DM 
Type 1 diabetes mellitus 
PAID 
Problem Areas in Diabetes 
CGMSS 
Glucose Monitoring System Satisfaction Survey  
HFS 
Hypoglycaemia Fear Survey 
HbA1c 
Haemoglobin A1 C 
NHS 
National Health Service 
ECG 
Electrocardiogram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KEYWORDS 
Type 1 diabetes, continuous glucose monitoring, glucose, insulin, hypoglycaemia 
 
 
 
 
 

 
I HART CGM 
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30th August 2015 
 
 
STUDY SUMMARY 
 
TITLE Impact on Hypoglycaemia Awareness of Real Time CGM and 
Intermittent Continuous Glucose Data 
DESIGN Randomised open-label parallel group study 
AIMS This study aims to assess the impact of real-time continuous glucose 
monitoring and intermittently viewed continuous glucose data on 
frequency, duration and severity of hypoglycaemia in people with type 1 
diabetes and impaired awareness of hypoglycaemia. 
OUTCOME MEASURES The primary outcome is percentage of time spent in hypoglycaemia 
(<3.3mmol/L, 60mg/dL) measured by a continuous glucose sensor. 
Secondary outcomes include other measures of hypoglycaemia, overall 
glucose status and patient reported quality of life. 
POPULATION Adults with type 1 diabetes and impaired hypoglycaemia awareness 
ELIGIBILITY Participants identified in type 1 diabetes clinics and by recruitment from 
existing databases. 
DURATION 18 weeks 
 
 
REFERENCE DIAGRAM 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomise 
Libre 
Dexcom G5 
Blinded Dexcom G4 
Dexcom G5 
8 weeks 
8 weeks 
2 weeks 

 
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1. 
INTRODUCTION  
 
1.1 
BACKGROUND 
Type 1 diabetes (T1DM) is characterised by autoimmune destruction of the pancreatic beta 
cell, leading to absolute deficiency of insulin. Management of T1DM requires exogenous 
insulin administration, aiming for glucose concentrations as close to physiological values as 
possible. Intensive management of T1DM improves glucose control and reduces the risk of 
microvascular diabetes complications and cardiovascular disease. However, optimal control 
remains challenging to achieve and intensive insulin treatment increases the risk of severe 
hypoglycaemia, with lower glucose values also associated with an increased frequency and 
severity of moderate hypoglycaemia. 
 
Hypoglycaemia is associated with morbidity and even mortality, and places a financial burden 
on health systems. Severe hypoglycaemia costs £13million per year in direct NHS costs and 
significantly more in indirect costs to people with diabetes, their families, friends and 
employers. Hypoglycaemia is one of the most common metabolic complications of the 
treatment of type 1 diabetes. Mild hypoglycaemia results in a variety of symptoms, including 
tremor, hunger, and anxiety, and, as glucose concentrations fall lower patients may develop 
cognitive impairment. Severe hypoglycaemia, defined as hypoglycaemia requiring the 
assistance of another person to treat, may cause seizures, coma, or death. Between 4 and 
10% of deaths in people with type 1 diabetes are attributed to hypoglycaemia and the risk of 
severe hypoglycaemia increases 6-fold in people with impaired awareness of hypoglycaemia. 
Avoidance of hypoglycaemia is associated with restoration of hypoglycaemia awareness and 
this may be enabled by the use of diabetes technology. 
 
Type 1 diabetes directly affects 300,000 people in the United Kingdom. In the UK diabetes 
consumes more than 10% of the National Health Service budget and in the USA a relatively 
greater amount is spent on type 1 compared with type 2 diabetes (8.6% of the diabetes budget 
compared with 5.6% of diabetes prevalence). 
 
Diabetes technologies, such as continuous glucose monitoring and insulin pump therapy can 
improve overall glucose control and may reduce the frequency and severity of  hypoglycaemia 
when used in combination with education and support for self-management. However, despite 
this, 72.4% of people with T1DM in England have an HbA1c over 58mmol/mol (7.5%) and 
16.6% have an HbA1c over 86mmol/mol (10%). Women aged 15 to 34 have a ninefold 
increase in mortality risk compared with women of the same age without diabetes. Diabetes 
remains the leading cause of blindness, amputation and end-stage renal failure in the 
developed world. 
 
In type 1 diabetes real-time continuous glucose monitoring (CGM) improves overall glucose 
control in all age groups when used continuously, reduces hypoglycaemia in people with an 
HbA1c <7.0%, and may reduce severe hypoglycaemia. 
 
The Dexcom G4 and G5 systems are CE marked real-time continuous glucose sensor 
systems which provide dynamic glucose information to people with type 1 diabetes, or their 
carers. These glucose data are updated every 5 minutes. Sensors are used for 7 days before 
replacement. The G4 system sensor requires calibration to capillary blood glucose values 
twice a day and verification with a capillary blood glucose test before treating diabetes based 
on sensor reported data. The Dexcom G5 can be used non-adjunctively (does not require pre-
treatment verification with capillary blood glucose before diabetes treatment decisions). The 
G5 system does require twice a day calibration with capillary blood glucose. 
 

 
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The Libre intermittent glucose monitoring system provides up to 8 hours of retrospective 
continuous glucose monitoring data to users when the monitor is waved in proximity with the 
sensor. In contrast to real-time CGM the Libre system sensor is used for 14 days and is non-
adjunctive. 
 
 
1.2 
RATIONALE FOR CURRENT STUDY 
This clinical study proposes to assess the impact of Libre on frequency, duration and severity 
of hypoglycaemia, compared with non-adjunctive use of the Dexcom G5 real-time CGM and 
will focus on people with impaired awareness of hypoglycaemia. 
 
Hypothesis: Libre intermittent CGM has an equivalent impact on hypoglycaemia to real-time 
CGM. 
 
 
2.  STUDY OBJECTIVES 
 
Primary outcome:  % time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) 
 
Secondary outcome: % time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) 
 
 
 
% time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) 
 
 
 
% time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) 
 
 
 
% time spent in target (3.9-10mmol/L, 70-180mg/dL) 
 
 
 
% time spent in hyperglycaemia (>10mmol/L, 180mg/dL) 
 
 
 
Number hypoglycaemic excursions 
 
 
 
Severe hypoglycaemia (requiring third party assistance to treat) 
 
 
 
MAD% 
 
 
 
Glucose variability 
 
 
 
HbA1c 
 
 
 
Sensor usage (compliance) 
 
 
 
Sensor life and % of sensor failure 
 
 
 
% of reported sensor readings compared to total possible readings 
 
 
 
Change in insulin dosage 
 
 
 
Diabetes treatment satisfaction 
 
 
 
CGM usability 
 
 
 
Diabetes quality of life 
 
 
 
Fear of hypoglycaemia 
 
 
 
Healthcare professional qualitative feedback 
 
 
3.  STUDY DESIGN 
 
Randomised parallel group trial over 18 weeks in 40 adult participants with type 1 diabetes 
and impaired hypoglycaemia awareness 
 
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
HbA1c 
Serum C-peptide 
Plasma glucose 
Gold score 

 
I HART CGM 
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4.2 
INCLUSION CRITERIA 
Adults over 18 years of age 
Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L 
Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold 
Score  ≥ 4 
Type 1 diabetes for greater than 3 years 
On an intensified multiple dose insulin injection regimen for > 6 months (MDI) 
Previous type 1 diabetes structured education (either group or 1:1) 
 
4.3 
EXCLUSION CRITERIA 
Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded 
use under clinic supervision) 
Use of regular paracetamol 
Pregnant or planning pregnancy 
Breastfeeding 
Enrolled in other clinical trials, except at the discretion of the chief investigator 
Have active malignancy or under investigation for malignancy 
Severe visual impairment 
Reduced manual dexterity 
Unable to participate due to other factors, as assessed by the Chief Investigators 
 
4.4 
WITHDRAWAL CRITERIA 
Participants will be withdrawn if their ability to give informed consent is impaired. Participants 
will also be withdrawn, at the chief investigators discretion, if glucose control is negatively 
impacted by the use of either intervention. 
 
 
5. 
ADVERSE EVENTS 
 
5.1 
DEFINITIONS   
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
 
Results in death 
 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
 
 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
 
Results in persistent or significant disability or incapacity 
 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 
5.3 
REPORTING PROCEDURES 
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   

 
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5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded.   
 
5.3.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  
However, hospitalisations for elective treatment of a pre-existing condition do not need 
reporting as SAEs. 
 
All SAEs should be reported to the NRES Committee London - Hampstead where in 
the opinion of the Chief Investigator, the event was: 
 
‘related’, ie resulted from the administration of any of the research procedures; 
and 
 
‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
Fax: 0207 594 2432, attention Dr Nick Oliver 
Please send SAE forms to:  
Diabetes, Endocrinology and Metabolism Medicine 
Imperial College 
Room G3, Medical School Building 
St Mary’s Campus 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 2460 (Mon to Fri 09.00 – 17.00) 
 
6. 
ASSESSMENT AND FOLLOW-UP  
 
Screening 
Following informed consent study participants will give a full medical history, and medication 
history and will undergo a physical examination and ECG. Fasting blood tests will be sent to 
assess HbA1c, plasma glucose, urea and electrolytes, serum C-peptide, thyroid function test, 
9 am cortisol and coeliac screen (tissue transglutaminase antibody). Women of childbearing 
age will have a urine pregnancy test. A Gold Score questionnaire will be completed. If 
participants meet the inclusion criteria they will complete a structured participant interview and 
Quality of Life Questionnaires. A type 1 diabetes structured education refresher will be 
delivered according to the study curriculum and data from the preceding 4 weeks will be 
downloaded from the participants capillary blood glucose monitor using the Diasend software. 
 
Run-in 
Participants will then commence a 2 week run-in phase using the Dexcom G4 sensor with a 
blinded receiver which stores glucose data but does not make it available to the participant.  
During the run-in phase participants will wear a Dexcom G4 continuous glucose sensor in the 

 
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anterior abdominal wall. The sensor detects glucose in the interstitial fluid and is calibrated to 
capillary blood glucose values taken a minimum of twice daily. Sensors last seven days and 
participants will be instructed on how to remove a sensor and implant a new one. This run-in 
will provide baseline data on glucose control including frequency and severity of 
hypoglycaemia and information on subject’s compliance with frequency of CGM use.  
 
Randomisation 
Participants will then receive standardised CGM education for the Dexcom and Abbott devices 
from study staff and will be randomised to Libre or the Dexcom G5 system with receiver. All 
education will be delivered by the research nurse from a predefined curriculum and will be 
supported by independent written materials. Both the Libre and G5 systems will be used non-
adjunctively (without capillary blood glucose verification before making a treatment decision, 
in accordance with product licences) but participants will be instructed to test their capillary 
blood glucose if symptoms of hypo- or hyperglycaemia occur, in case of sensor failure or if the 
sensor glucose is out of the desired range. Participants will use the G5 sensor with the 
accompanying receiver and will change sensor every seven days (or sooner in the event of 
sensor failure). Real-time glucose data will be available to participants. Participants will use 
the Libre sensor with the accompanying receiver and will change the sensor after 14 days (or 
sooner in the event of sensor failure). Participants will be enabled to use the Libre monitor to 
assess glucose value and trend as often as they choose. 
 
Follow-Up 
There will be a telephone visit 2 weeks after randomisation with a short, structured interview 
focusing on the function of the technology and any difficulties with use.  
 
Participants will attend the clinical research facility 4 weeks after randomisation and data will 
be downloaded from their CGM device and self-monitoring using the Diasend software. At 8 
and 16 weeks after randomisation participants will attend the clinical research facility and will 
have a blood test for HbA1c. They will additionally complete a Gold Score questionnaire, 
repeat the Quality of Life questionnaires, undergo a semi-structured interview conducted by 
the research team and data will be downloaded from their CGM device and capillary blood 
glucose monitor. 
 
After 8 weeks all participants will be offered the opportunity to continue with the Dexcom G5 
system for a further 8 week period. The G5 system in the follow-on may be used with the 
Dexcom receiver or Apple iOS smartphone application and will focus on usability, 
psychosocial outcomes and qualitative interviews. Participants will change the G5 sensor 
every seven days (or sooner in the event of sensor failure). 
 
The participants will be provided with a contact number for technical support but insulin titration 
decisions will be made by the participant. 
 
Quality of life, CGM-related treatment satisfaction and fear of hypoglycaemia data will be 
collected by mixed quantitative and qualitative methodologies. Validated (Problem Area in 
Diabetes (PAID),,Glucose Monitoring System Satisfaction Survey (GMSS), Hypoglycaemia 
Fear Survey-II(FHS-II)) and non-validated questionnaires will be used and scripted 
interviews with participants will be undertaken by the research team to assess the impact of 
the technology on everyday living with type 1 diabetes. Gold questionnaire will be used to 
assess impact on hypoglycaemia awareness. 
 
Low glucose alert settings will be standardised at 4.4 mmol/L (80mg/dL) for all participants at 
the start of the study and can be reduced to 4 mmol/L (70mg/dL) at week 2 depending during 

 
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the telephone visit depending on participant preference. High glucose alerts may be 
personalised. 
 
The study will be completed at the end of the 8 week open label period. 
 
 
7. 
STATISTICS AND DATA ANALYSIS 
 
With 40 participants, we can demonstrate as significant at 80% power a mean difference in 
time in hypoglycaemia between Libre and G5 of 0.45 standard deviations. Any smaller 
difference will be distinguished as signifying no significant difference between Libre and CGM. 
To allow for a 10-15% drop out, 45 participants will be recruited. Randomisation will be 
stratified by HbA1c quartiles (5-6%, 6.1-7.0%, 7.1-8.0% and 8.1-9%). Randomisation will be 
done using sealedenvelope.com. 
 
Baseline data will be taken from the first 14 days of monitoring and outcomes will be 
calculated from the last 30 days in each treatment period.  
  
Analysis will be by intention to treat. The primary outcome will be assessed by two-tailed 
unpaired t-test. For secondary outcomes parametric data will be compared between the two 
study arms by two-tailed unpaired t-test for continuous variables. Non-parametric data will be 
compared using a Kruskall Wallis test. 
 
Data and all appropriate documentation will be stored for a minimum of 10 years after the 
completion of the study, including the follow-up period.   
 
 
8. 
REGULATORY ISSUES 
 
8.1 
ETHICS APPROVAL 
The Chief Investigator has obtained approval from the London Hampstead Research Ethics 
Committee.  The study must be submitted for Site Specific Assessment (SSA) at each 
participating NHS Trust.  The Chief Investigator will require a copy of the Trust R&D and MHRA 
approval letter before accepting participants into the study.  The study will be conducted in 
accordance with the recommendations for physicians involved in research on human subjects 
adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. 
 
8.2 
CONSENT  
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that specified in the protocol at any stage 
if he/she feels it is in the participant’s best interest, but the reasons for doing so should be 
recorded.  In these cases the participants remain within the study for the purposes of follow-
up and data analysis.  All participants are free to withdraw at any time from the protocol 
treatment without giving reasons and without prejudicing further treatment. 
 
8.3 
CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. 
 

 
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8.4 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study. 
 
8.5 
SPONSOR 
Imperial College London will act as the main Sponsor for this study.  Delegated responsibilities 
will be assigned to the NHS trusts taking part in this study.   
 
8.6 
FUNDING 
Dexcom are funding this study.  Participants will be fully reimbursed for travel expenses. 
 
8.7 
AUDITS  
The study may be subject to inspection and audit by Imperial College London under their remit 
as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS Research 
Governance Framework for Health and Social Care (2nd edition).  
 
 
9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through the Chief Investigator, 
Dr Nick Oliver.   
 
10. 
PUBLICATION POLICY 
 
Data from the study will be analysed then published in peer-reviewed scientific journals and 
presented at Scientific Conferences. A lay summary of the data will be disseminated to all 
participants and a summary of results will be publically available. 
 
 
10. 
REFERENCES 
 
1. Wright RJ, Frier BM, Deary IJ. Effects of acute insulin-induced hypoglycemia on 
spatial abilities in adults with type 1 diabetes. Diabetes Care. 2009; 32(8):1503-1506 
2. Rankin D, Elliott J, Heller S, Amiel S, Rogers H, DeZoysa N et al. Experiences of 
hypoglycaemia unawareness amongst people with Type 1 diabetes: A qualitative 
investigation. Chronic Illness. 2013; 10(3):180-191 
3. Lawton J, Rankin D, Elliott J, Heller SR, Rogers HA, de ZN et al. Experiences, views, 
and support needs of family members of people with hypoglycemia unawareness: 
interview study. Diabetes Care. 2014; 37(1):109-115 
4. Heller SR, Cryer PE. Reduced neuroendocrine and symptomatic responses to 
subsequent hypoglycemia after 1 episode of hypoglycemia in nondiabetic humans. 
Diabetes. 1991; 40(2):223-226 
5. Geddes J, Schopman JE, Zammitt NN, Frier BM. Prevalence of impaired awareness 
of hypoglycaemia in adults with Type 1 diabetes. Diabetic Medicine. 2008; 25(4):501-
504 
6. Dagogo-Jack SE, Craft S, Cryer PE. Hypoglycemia-associated autonomic failure in 
insulin-dependent diabetes mellitus. Recent antecedent hypoglycemia reduces 
autonomic responses to, symptoms of, and defense against subsequent 
hypoglycemia. Journal of Clinical Investigation. 1993; 91(3):819-828 
7. Cranston I, Lomas J, Maran A, Macdonald I, Amiel SA. Restoration of hypoglycaemia 
awareness in patients with long-duration insulin-dependent diabetes. Lancet. 1994; 
344(8918):283-287  

 
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8. Cryer PE. Severe hypoglycemia predicts mortality in diabetes. Diabetes Care. 2012; 
35(9):1814-1816 
 
APPENDICES 
 
 
Summary of investigations, treatment and assessments 
 
Dexcom G4/ G5 instructions for use 
 
Abbott Libre instructions for use 
 
Validated questionnaires 
 
PAID 
 
Gold 
 
CGMSS 
 
HFS-II 
 
CGM questionnaire 
 
 
 
 
 

 
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Appendix 1. Summary of investigations, treatment and assessments 
 
 
Screening 
Randomisation 
2 weeks 
4 weeks 
8 weeks 
16 weeks 
History 
x 
 
 
 
 
 
Medication 
history 
x 
 
 
 
 
 
ECG 
x 
 
 
 
 
 
Physical 
examination 
x 
 
 
 
 
 
Urine 
pregnancy test 
x 
 
 
 
 
 
HbA1c 
x 
 
 
 
x 
x 
Glucose 
x 
 
 
 
 
 
Urea/ 
electrolytes 
x 
 
 
 
 
 
TFT 
x 
 
 
 
 
 
9am cortisol 
x 
 
 
 
 
 
Coeliac screen 
x 
 
 
 
 
 
C-peptide 
x 
 
 
 
 
 
Gold Score 
x 
 
 
 
x 
x 
Participant 
interview 
 
x 
 
 
x 
x 
QoL 
Questionnaires 
 
x 
 
 
x 
x 
Diabetes 
Education 
 
x 
 
 
 
 
CGM education 
 
x 
 
 
 
 
Meter download 
 
x 
 
x 
x 
x 
Telephone 
consultation 
 
 
x 
 
 
 
CGM download 
 
 
 
x 
x 
x 
Research clinic 
visit 
x 
x 
 
x 
x 
x