Avoidance of Hyperglycaemia in People With Type 1 Diabetes
Conditions: Diabetes Mellitus, Type 1
Sponsor: Imperial College London

 
 
Avoidance of Hyperglycaemia in people with Type 1 Diabetes (HYPE)  
Study IRAS ID 288601 
Protocol v1.3 20 08 2021 
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HYPE 
 
 
 
 
 
Avoidance of Hyperglycaemia in people with Type 1 Diabetes 
 
 
 
 
V1.3 
 
 
 
 
 
MAIN SPONSOR:  
 
 
Imperial College London 
FUNDERS:  
 
 
 
Imperial Charity Pre-doctoral Fellowship 
STUDY COORDINATION CENTRE: Imperial College London 
 
IRAS Project ID: 
288601 
REC reference:  
20/SW/0174 
 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Avoidance of Hyperglycaemia in people with Type 1 Diabetes (HYPE)  
Study IRAS ID 288601 
Protocol v1.3 20 08 2021 
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Study Management Group 
 
Chief Investigator:  
 
Prof Nick Oliver 
Co-investigator:  
 
Dr Vicky McKechnie 
Statistician:  
 
 
Dr Ian Godsland  
Research Collaborator:  
Professor John Fox 
Study Management:   
Dr Vicky McKechnie 
 
 
Clinical Queries 
 
Clinical queries should be directed to Prof 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: 
 
 
 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 9459/ 0207 594 1862 
http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice  
 
This protocol describes the HYPE 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 UK Policy Frame Work for Health and 
Social Care Research. It will be conducted in compliance with the protocol, the Data Protection 
Act and other regulatory requirements as appropriate.  
 
 

 
 
Avoidance of Hyperglycaemia in people with Type 1 Diabetes (HYPE)  
Study IRAS ID 288601 
Protocol v1.3 20 08 2021 
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Table of Contents                                                             Page No 
1. 
INTRODUCTION 
667 
1.1 
BACKGROUND 
667 
2.  STUDY OBJECTIVES 
778 
3.  STUDY DESIGN 
889 
3.1 
STUDY OUTCOME MEASURES 
889 
4. 
PARTICIPANT ENTRY 
9910 
4.1 
PRE-REGISTRATION EVALUATIONS 
9910 
4.2 
INCLUSION CRITERIA 
9910 
4.2 
EXCLUSION CRITERIA 
9910 
4.3 
WITHDRAWAL CRITERIA 
9910 
5. 
ADVERSE EVENTS 
101011 
5.1 
DEFINITIONS 
101011 
5.2 
REPORTING PROCEDURES 
101011 
6. 
ASSESSMENT AND FOLLOW-UP 
121213 
7. 
STATISTICS AND DATA ANALYSIS 
161617 
8. 
REGULATORY ISSUES 
181819 
8.1 
ETHICS APPROVAL 
181819 
8.2 
CONSENT 
181819 
8.3 
CONFIDENTIALITY 
181819 
8.4 
INDEMNITY 
181819 
8.5 
SPONSOR 
181819 
8.6 
FUNDING 
191920 
8.7 
AUDITS 
191920 
9. 
STUDY MANAGEMENT 
202021 
10. 
PUBLICATION POLICY 
212122 
11. 
REFERENCES 
222223 
12. APPENDICES 
232324 

 
 
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APPENDIX 1. STUDY QUESTIONNAIRES (ATTACHED SEPARATELY) 
232324 
APPENDIX 2.  DATA FLOW MAPPING 
242425 
 
 
 

 
 
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Protocol v1.3 20 08 2021 
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GLOSSARY OF ABBREVIATIONS 
T1D 
Type 1 Diabetes 
 
KEYWORDS 
Diabetes Mellitus, Hyperglycaemia,  
 
STUDY SUMMARY 
 
TITLE 
Avoidance of Hyperglycaemia in people with Type 1 Diabetes 
DESIGN 
Non-interventional, Cross-sectional study 
AIMS 
To assess how problematic fear of hyperglycaemia is in people with 
T1D 
OUTCOME 
MEASURES 
Quantitative and qualitative measures 
POPULATION 
n=up to 350 
ELIGIBILITY 
Diagnosis of T1D for at least 6 months 
DURATION 
1 hour per participant, 9 months total study duration. Participants 
who participate in the interview study (n=16) will undergo an 
additional 90 minute interview. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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1. 
INTRODUCTION  
1.1 
Background 
Approximately 400000 people in the UK have T1D (1). Self-management of T1D involves a 
challenging regimen requiring monitoring of blood glucose levels several times per day and 
multiple daily insulin injections. People living with T1D can experience a number of psychological 
difficulties, including feeling burned out, fear of high and low blood glucose levels, adjustment to 
diabetes-related complications, and problems around eating. Higher levels of diabetes-related 
distress are associated with a higher HbA1c (2,3) which is associated with increased risk of micro- 
and macro vascular diabetes-specific complications. The importance of psychological support for 
people with T1D is increasingly recognised (4), and both published and Imperial data demonstrate 
the importance of psychological support (5,6). 
 
Published data describe the assessment and consequences of fear of hypoglycaemia in people 
with T1D (7,8). Hypoglycaemia fear is associated with a higher HbA1c and increased risk of 
diabetes-related complications. The Hypoglycaemia Fear Survey (HFS-ii) (9,10) is a valid and 
reliable tool for assessment used in routine clinical care, including in the psychological 
assessment and intervention outcome data for the Imperial T1D Psychology service. NICE 
guidelines (11) reference fear of hypoglycaemia as a barrier to achieving HbA1c targets and 
recommend continuous glucose monitoring for those with extreme fear. 
There is, however, little research about fear, or problematic avoidance, of hyperglycaemia in 
T1D (12). It is, however, a problem that we see in the T1D clinics at Imperial, often with 
significant adverse consequences. As well as high levels of distress, it is associated with 
recurrent hypoglycaemia exposure, eroded hypoglycaemia awareness and increased 
healthcare utilisation (13). More problematically, fear of hyperglycaemia may not be identified, 
as the HbA1c is often at, or below, target.  
 
1.2 
Rationale for current study 
Fear of hyperglycaemia represents a gap in knowledge and has implications for clinicians’ skills 
in recognising this problem, and for understanding how best to support the people who 
experience it. 
 
 

 
 
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2.  STUDY OBJECTIVES 
 
Primary Objective 
 
Assess how problematic fear of hyperglycaemia is in T1D 
 
Secondary Objectives 
Identify whether fear of hyperglycaemia is associated with any clinical factors 
Identify the psychological factors that underpin fear of hyperglycaemia  
Assess how fear of hyperglycaemia affects self-management of T1D 
 
 
 

 
 
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3.  STUDY DESIGN 
Non-interventional, cross-sectional questionnaire study in adults with T1D  
1 hour per participant, 9 months total  
n=up to 350 participants total 
Sub study of approximately n=16 participants for semi-structured interviews (1.5 hours per 
participant) 
 
3.1 
Study Outcome Measures 
1. Quantitative data: 
a. Hyperglycaemia avoidance scale (HAS) 
b. Hypoglycaemia fear survey (HFS-II) 
c. Problem areas in diabetes scale 5 (PAID-5) 
d. Patient health questionnaire (PHQ-9) 
e. Generalised anxiety disorder scale (GAD-7) 
f. State trait anxiety inventory (Trait subscale) 
 
2. Descriptive data – semi-structured interview 
Additional baseline participant data to be pulled from Cerner/via participant survey: 
 
Age 
 
Ethnicity 
 
Length of diabetes 
 
Current diabetes treatment 
 
Diabetes complications: nephropathy, neuropathy, retinopathy, cardiovascular 
disease 
 
Recent HbA1C 
 
Other medical conditions 
 
Other medications 
 
Hypos – frequency/severity 
 
Blood glucose monitoring - method and frequency 
 
 
 
 

 
 
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4. 
PARTICIPANT ENTRY  
4.1 
Pre-registration evaluations  
Potential participants will be identified by the clinical diabetes team from the list of people who 
attend the diabetes clinics at Imperial College Healthcare NHS Trust. Participants with type 1 
diabetes who do not attend an Imperial College Healthcare NHS Trust diabetes clinic who 
have consented to be contacted by the Imperial diabetes research team for research purposes 
will also be invited to participate in the study.  
 
Of the participants who are enrolled in the study, and who have consented to be contacted for 
an interview, the research team plans to select approximately 16 participants to take part in 
the qualitative interview. Participants will be selected based on clinician identification and 
participant self-identification of fear of hyperglycaemia, as well as from a dynamic list of those 
in the upper quadrant of recorded scores on the Hyperglycaemia Avoidance Scale.  
 
4.2 
Inclusion Criteria 
 
Previous diagnosis of Diabetes Mellitus of at least 6 months   
 
Aged 18 or above 
 
4.2 
Exclusion Criteria 
 
Inability to understand and write in the English language 
 
Unable to participate due to other factors, as assessed by the Chief Investigators 
 
Pregnant women 
 
4.3 
Withdrawal criteria 
 
Loss of capacity to give informed consent 
 
Investigator initiated discontinuation of study due to participation concerns 
 
Withdrawal will be immediate, and participants will be followed up in the appropriate out-
patient diabetes clinic at their usual appointments. If a participant withdraws no more data will 
be collected on them but identifiable data already collected with consent will be retained and 
used in the study. 
 
If a participant, who has given informed consent, loses capacity to consent during the study 
the participant will be withdrawn from the study. Identifiable data already collected with 
consent will be retained and used in the study. No further data would be collected or any other 
research procedures carried out on or in relation to the participant. 

 
 
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Protocol v1.3 20 08 2021 
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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. 
 
5.2 
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.   
 
5.2.1 Non serious AEs 
All such events, whether expected or not, should be recorded.   
 
5.2.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  
However, relapse and death due to diabetes mellitus, and hospitalisations for elective 
treatment of a pre-existing condition do not need reporting as SAEs. 
 

 
 
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All SAEs should be reported to the Cornwall and Plymouth REC where in the opinion of the 
Chief Investigator, the event was: 
 
‘related’, i.e. resulted from the administration of any of the research procedures; 
and 
 
‘unexpected’, i.e. 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 
jrco@imperial.ac.uk 
CI email (and contact details below) 
Fax: 020 7594 2432, attention Prof Nick Oliver 
Please send SAE forms to: Diabetes, Endocrinology and Metabolism Medicine, Imperial 
College London, Room G3 Medical School Building, St Mary’s Campus, Norfolk Place, 
London W2 1PG 
Tel: 020 7594 2460 (Mon to Fri 09.00 – 17.00) 
 
 
 

 
 
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6. 
ASSESSMENT AND FOLLOW-UP  
 
The main study will consist of completing a survey and some questionnaires.  This should take 
no more than 1 hour to complete by the participant at a time and location convenient to them. 
Participants will be invited to consent to be contacted for the optional sub-study which will be 
described later in this section. 
 
All eligible participants will be identified by the clinical care team.  A list of potential participants 
will be identified from the database of all people who attend the diabetes clinics at Imperial 
College Healthcare NHS Trust (subsequently known as the participant database). Additionally, 
eligible participants from the list of non-Imperial research consenters will also be contacted 
about the study. 
 
Potential participants will be contacted in one of three ways by the clinical team: 
 
a) Participants whose emails are available on Cerner or who are not Imperial patients but 
have consented to contact for research will be contacted by email by a member of the 
research team. The email will include the PIS and a link to Qualtrics (an online data 
collection platform which is supported by the college). Informed consent will be taken 
via this platform with questionnaires to follow (only accessible if participant has 
consented to all clauses and signed electronically). Participants will be able to arrange 
a phone call with the research team to discuss any issues or concerns before signing 
the consent if they wish.  Participants who attend clinics at Imperial College Healthcare 
NHS Trust will be provided with a unique code to enable researchers to link their 
questionnaire data with their medical records. This will be different to the study code 
and which will be assigned to participants after consent in order of enrolment. 
b) For potential participants whose emails are not available or who prefer a hard copy 
approach, study packs, including the patient information sheet, consent form and 
questionnaire will be sent by post for completion at home, and returned in a pre-paid 
addressed envelope to the research team.  
c) Patients who are seen in clinic by the diabetes team will be approached by their clinical 
team about participating in the study. Those who are interested will then be provided 
with a consent form and study questionnaire which can either be completed and 
returned to the research team whilst in the clinic or taken home and returned in a 
stamped addressed envelope at the participant’s convenience. 

 
 
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Of the participants who are enrolled in the study, and who have consented to be contacted for 
an interview, the research team plans to select approximately 16 participants to take part in 
the qualitative interview. Participants will be selected based on clinician identification and 
participant self-identification of fear of hyperglycaemia, as well as from a dynamic list of those 
in the upper quadrant of recorded scores on the Hyperglycaemia Avoidance Scale.  
 
Participants will be advised that questionnaires should be returned by the end of the study for 
inclusion in the study analysis. 
 
Within the patient information sheet there will be contact details for the research team, should 
the participant wish to discuss the study and obtain any further details.   
 
Once returned, the pseudonymised questionnaire data will be recorded in a password 
encrypted database on an Imperial College Healthcare NHS Trust or Imperial College London 
computer (subsequently known as the results database). Informed consent will be filed in the 
trial master file. 
 
Once informed consent has been provided, the research team will then review the electronic 
health records of those Imperial College Healthcare NHS Trust participants who have 
consented to record biochemical data, medical history. Other baseline data e.g.  
demographics will be collected via a participant survey which will be mailed alongside 
questionnaires. This data will be recorded in pseudonymised form in the results database. 
Data from Qualtrics will be downloaded in a PDF format on either an ICL or ICHT computer 
and printed for hard copy records. Questionnaire scoring data will be pulled from Qualtrics in 
a pseudonymised format and saved on either an ICL or ICHT computer within an encrypted, 
password protected document. 
 
In all cases, no samples are taken and all data will be pseudonymised. No follow up outside 
of usual care will be provided.  
 
If participants wish to see their questionnaire scores, they will be able to request this. They 
will be sent a standardised letter including their scores on each measure and, where available, 
what this score is suggestive of (e.g. mild depression). Some of the measures do not have 
standardised cut-offs. This will only be sent if requested and not for all participants. 
  

 
 
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Any participant who scores in the severe range on the GAD-7 (scores of 15-21) or the PHQ-9 
(scores of 20-27), or who scores 3 on question 9 of the PHQ-9 (this question relates to 
thoughts of harm to self) will have a letter sent to their GP advising them of this, and the 
participant will receive a copy.  
  
Any disclosure made to the researchers that constitutes a safeguarding issue, or a potential 
risk to self or others, will be shared with the clinical team and managed appropriately as per 
the usual clinical care pathway, including contacting other agencies where indicated. Where 
participants report mental health problems such as anxiety or depression, based on the 
Clinical Psychologist's judgement, they will be signposted or, where appropriate, referred, to 
appropriate mental health services as is usual practice in their clinical care. This might include, 
for example: their local mental health trust's Single Point of Access; Improving Access 
to Psychological Therapies (IAPT); the London-wide Type 1 Disordered Eating Service.  
  
If the participant raises concerns that they do not wish to be shared with their clinical care 
team, but the researcher feels should be shared, an anonymised discussion will be initiated 
with the Principal Investigator, and if appropriate, the clinical care team. The Trust Ethics 
Committee can also be consulted, if appropriate, to consider what is in the participant's best 
interests.   
 
Participants’ GPs will not be informed of their participation in the study as it will not affect their 
care. 
 
End of study will be defined as last subject last visit (LSLV). 
 
Sub-study – Qualitative semi-structured interview 
Of the participants who are enrolled into the study (and who have consented to be contacted 
for an interview) the research team plan to select approximately 16 whose HAS scores are 
relatively higher than other participants in order to conduct a qualitative semi-structured 
interview. This will be judged from previous research and participants who score in the upper 
quartile of the entire measure. (Singh et al., 2014).  Participants of varying backgrounds will 
be selected to ensure a mix of demographics, diabetes duration, HbA1c etc. This is in order 
to ensure a heterogeneous pool of participants to inform our hypothesis.  
 
Participants will not be reconsented to take part in the interview study as they will have already 
opted in on the original consent form, having read the PIS which details this sub study. The 

 
 
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interviews will take place either remotely via Microsoft teams or face to face at St Mary’s 
hospital.  
 
An inductive, exploratory approach will be taken to learn more about fear of hyperglycaemia. 
An initial semi-structured interview schedule will be used to guide the interviews and, in line 
with the grounded theory approach, the information gathered from interviews will be used to 
shape and inform subsequent participant interviews as hypotheses and theories are 
developed. The interview will be conducted by a clinical psychologist, will last a maximum of 
90 minutes and will be recorded and then transcribed verbatim by the clinical psychologist.  
 
The audio recording will be anonymous and will be destroyed once the interview has been 
transcribed. The interview will be transcribed in pseudonymous format. After the interview, the 
clinical psychologist will email the participant with the themes that they identified during the 
interview. This is called a credibility check and the participant will be asked to respond with 
confirmation that they agree/disagree with the themes that have been outlined. A third party 
(who will be an appropriately qualified member of the research team employed under ICHT) 
will review the pseudonymised transcripts and provide feedback. This is the second part of 
the credibility check. This third party will not have access to the identifiable codes. 
 
The psychologist is experienced in sensitively discussing difficult and distressing topics with 
individuals and will routinely debrief all participants at the end of each interview. If during the 
course of interviews, individuals disclose actual or possible risk of harm to self or others, this 
will be assessed and managed using the same procedures that are used in a clinical setting. 
 
 
 

 
 
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7. 
STATISTICS AND DATA ANALYSIS 
 
Approximately 350 participants have been identified. This includes people who attend the 
Imperial College Healthcare NHS Trust diabetes clinics, and people who have given the 
Imperial diabetes research team their consent to be contacted for research.  Approximately 
16 potential participants will be enrolled into the interview sub-study. This is based on the 
number estimated to be required to identify no new themes (i.e. reach saturation).  
 
Of the participants who are enrolled into the study (and who have consented to be contacted 
for an interview) the research team plan to select approximately 16 whose HAS scores are 
relatively higher than other participants in order to conduct a qualitative semi-structured 
interview. This will be judged from previous research and participants who score in the upper 
quartile of the entire measure. (Singh et al., 2014).  Participants of varying backgrounds will 
be selected to ensure a mix of demographics, diabetes duration, HbA1c etc. This is in order 
to ensure a heterogeneous pool of participants to inform our hypothesis.  
 
This study contains both descriptive and quantifiable data.  The quantitative outcomes may 
be either ordinal or categorical, and proportions tests, including Chi squared tests, t-tests and 
ANOVAs will be used to determine differences between these outcomes.  
 
The descriptive data will be tabulated and presented as such without statistical analysis. 
Interviews will be audio-recorded and transcribed verbatim. They will be analysed using a 
grounded theory approach (Corbin & Strauss, 1990), which aims to develop a set of concepts 
that provide a theoretical explanation of the phenomenon being studied. Analysis will take 
place alongside data collection, as it will inform and direct subsequent interviews. Credibility 
checks (Elliott, Fischer & Rennie, 1999; Stiles, 1993) will involve a third-party examining 
sections of analysed interview transcripts and providing feedback. In addition to this the 
researcher will contact the interview participant participants to check the themes with the 
interview participant and providing feedback.  
 
All personal details will be sent via encrypted email (nhs.net). 
 
Record linking participant information to study ID will be stored securely on an Imperial College 
NHS trust Computer. All study data will be stored in a pseudonymised format in an encrypted 
database on an Imperial College NHS trust computer OR Imperial College London computer. 

 
 
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Audio recordings will be recorded on a secure dictaphone in pseudonymised form and once 
transcribed will be destroyed. All transcribed data will be stored on an ICHT or ICL  computer 
in pseudonymous form. 
 
Direct quotations may be published in anonymous fashion. The NHS Code of Confidentiality 
will be followed at all times. All data is to be stored in a pseudonymised form by using study 
codes for de-identification of participants.  Examples of such a code includes: HYPE001 
(assigned in order of enrolment). Identifiable Personal data will be kept in files in a locked 
office within Imperial College London, accessible only by the research/clinical team. 
Pseudonymised data will be stored in a password encrypted spreadsheet on ICHT/ICL 
computers, accessible only by the research team. 
 
Data and all appropriate documentation will be pseudonymised and stored for a minimum of 
10 years after the completion of the study in line with Imperial College policy.   
 
 
 

 
 
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8. 
REGULATORY ISSUES 
 
8.1 
Ethics approval 
The Study Coordination Centre has obtained approval from the Cornwall and Plymouth 
Research Ethics Committee (REC) and Health Regulator Authority (HRA). The study must 
also receive confirmation of capacity and capability from each participating NHS Trust before 
accepting participants into the study or any research activity is carried out. 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 
Anonymised quotes may be used in publications if the participant has given written informed 
consent. The Chief Investigator will preserve the confidentiality of participants taking part in 
the study and is registered under the Data Protection Act. 
 
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.   
 

 
 
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8.6 
Funding 
The study is funded by the Imperial Health Charity. No payments will be made to participants 
or investigators in this study.  
 
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 UK Policy 
Framework for Health and Social Care Research.  
 
 
 
 

 
 
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9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through Prof Nick Oliver.   
 
 
 
 
 
 

 
 
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10. 
PUBLICATION POLICY 
The study will be registered on the clinicaltrials.gov system and results will be disseminated 
by peer reviewed scientific journals, internal report, conference presentation and publication 
on websites. No identifiable personal data will be published. Anonymised quotes may be 
included in publications if the participant has given informed written consent. All anthropometry 
and personal clinical data will be expressed as mean/ median and spread of the population in 
the study. All participants will be informed of the results by letter at the conclusion of the study 
and details of any publications that arise from the study will be disseminated to participants.   
 
 
 
 

 
 
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11. 
REFERENCES 
1. JDRF (2019). Type 1 Diabetes facts and figures. https://jdrf.org.uk/information-
support/about-type-1- diabetes/facts-and-figures/  (Accessed  03.12.2019) 
2. Strandberg RB, Graue M, Wentzel-Larsen T et al. (2014). Relationships of 
diabetes-specific emotional distress, depression, anxiety and overall well-
being with HbA1c in adult persons with type 1 diabetes. Journal of 
Psychosomatic Research, 77, 174-179 
3. Todd PJ, Edwards F, Spratling L et al. (2017). Evaluating the relationships of 
hypoglycaemia and HbA1c with screening-detected diabetes distress in type 1 
diabetes. Endocrinology, Diabetes and Metabolism, e00003. 10.1002/edm2.3. 
4. All Parliamentary Group for Diabetes (2018). Diabetes and Mental Health 
Report 
(Available 
at: 
https://diabetesappg.files.wordpress.com/2018/08/appg-mental-
health-report_v3.pdf) 
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12. APPENDICES 
 
Appendix 1. Study Questionnaires (attached separately) 
 
 Hyperglycaemia avoidance scale (HAS) 
 Hypoglycaemia fear survey (HFS-II) 
 Problem areas in diabetes scale 5 (PAID-5) 
 Patient health questionnaire (PHQ-9) 
 Generalised anxiety disorder scale (GAD-7) 
 State trait anxiety inventory (Trait subscale) 
 semi-structured interview 
 
 
 
 

 
 
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Appendix 2.  Data Flow Mapping