Patient/Carer Survey

The following is an abridged version of the survey presented to adult patients and paediatric carers. Additional questions were included but not analysed for this study; these questions are not presented here.

  1. Study background information

A1. How do I take part in this survey study?

Before you decide if you want to take part in this survey study, please read the following information.

You can change your mind about taking part and exit the survey at any time. You should only take part in this study if you want to.

A2. What is the purpose of this survey study?

We would like to understand what happens when patients with Type 1 diabetes have raised ketone levels (known as ketosis). We would like to know what you do when this happens and understand the type of help that you seek.

A3. What are the possible benefits of taking part?

There is no direct medical benefit to you. The information you provide will contribute to researchers' understanding of ketosis.

A4. Who is organising the research?

This research is being managed by DRG Abacus, a healthcare research company, and funded by a pharmaceutical company.

A5. What will happen to the results of the survey?

The information collected will be anonymous.

The survey results will be analysed by the research team and a summary of the findings will be shared with the sponsoring pharmaceutical company. The anonymised results of this overall research may be published in a scientific journal.

  1. Informed consent

B1. Have you read and understood the information about this survey study?

□  Yes

□  No (àExclude. SCREEN OUT)

B2. Do you agree to participate in this survey study?

□  Yes

□  No (à Exclude. SCREEN OUT)

  1. Inclusion criteria

C1. Are you aged 18 or over?

□  Yes

□  No (à Exclude. Skip to section X SCREENOUT)

C2. Have you or your child been diagnosed with Type 1 Diabetes Mellitus?

□  Yes – I have been diagnosed with Type 1 diabetes

□  Yes – My child has been diagnosed with Type 1 diabetes

□  Yes - Both myself and my child have been diagnosed with Type 1 diabetes, but I will be giving answers about my own experiences during this survey.

□  Yes - Both myself and my child have been diagnosed with Type 1 diabetes, but I will be giving answers about my child's experiences during this survey.

□  No (à Exclude. Skip to section X SCREENOUT)

C2a. How old is your child

□  0-4 years old

□  5-11 years old

□  12-18 years old

C2b. How old are you

□  18-25 years old

□  26-74 years old

□  75+ years old

C3. When were you [was your child] diagnosed with Type 1 Diabetes Mellitus?

□  Less than 12 months ago (à Exclude. Skip to section SCREENOUT)

□  Over 12 months ago

□  Unable to remember (à Exclude. Skip to section X SCREENOUT)

C4. Have you collected a prescription for ketone strips in the last 12 months?

□  Yes

□  No (à Exclude. Skip to section X SCREENOUT)

C5. Have you [Has your child] had raised ketone levels in the last 12 months?

□  Yes

□  No (à Exclude. Skip to section X SCREENOUT)

□  Unable to remember (à Exclude. Skip to section X SCREENOUT)

Information about your child

  1. What is your child's gender?

□  Male

□  Female

□  Prefer not to say

  1. What is your child's ethnicity?

□  White

□  Mixed / Multiple ethnic groups

□  Asian / Asian British

□  Black / African / Caribbean / Black British

□  Other ethnic group

□  I would rather not say

  1. Does your child attend school or another place of education?

□  Not in school or other education

□  Nursery or other child-care

□  Pre-school

□  Primary school (including infant or junior)

□  Secondary school

□  Sixth form college or college of further education

□  University

Information about you

  1. What is your gender?

□  Male

□  Female

□  Prefer not to say

  1. What is your ethnicity?

□  White

□  Mixed / Multiple ethnic groups

□  Asian / Asian British

□  Black / African / Caribbean / Black British

□  Other ethnic group

□  I would rather not say

  1. How would you describe your work status?

□  Working full time in paid job

□  Working part-time in paid job

□  Volunteer work

□  Looking for work

□  Full-time homemaker

□  Student

□  Retired

□  Not working due to my/my child’s Type 1 Diabetes

□  Not working due to medical problems other than Type 1 Diabetes

  1. What was the highest level of education you completed?

□  University higher degree / Postgraduate degree (e.g., MSc, PhD)

□  First degree level / Undergraduate degree

□  Diploma in higher education

□  A/AS Level or equivalent

□  GCSE/O Level

□  CSE

□  None of the above

  1. Survey instructions

In this survey we would like to understand what happens when people with type 1 diabetes have raised ketone levels (known as ketosis). We would like to know what you do when this happens and understand the type of help that you seek.

  1. Your [your child's] diabetes
  1. How long ago were you [your child] diagnosed with Type 1 Diabetes Mellitus?

□  Between 1–2 years ago

□  Between 3–5 years ago

□  Over 5 years ago

□  Over 10 years ago

  1. How well do you understand how to identify and manage ketones?

□  Not at all

□  Somewhat

□  Mostly

□  Completely

  1. Have you been on a DAFNE course?

□  Yes

□  No

  1. How do you monitor your [your child's] ketone levels?

What do we mean by "raised ketone levels"?

If your body doesn't have enough insulin, it will start breaking down fat, rather than sugar, for energy. When fat breaks down, ketones are formed, and these ketones build up in your blood and leave the body in your urine.

When ketones are in your blood or urine, you have raised ketone levels, known as ketosis. You can treat ketosis by giving yourself an extra dose of insulin and drinking lots of fluids. You might treat ketosis at home on your own, or you might seek some help from a healthcare professional.

If you don't realise you have ketones in your blood, and give yourself treatment, the ketones will continue to build up until there are so many in your blood that your body becomes acidotic. You might have heard this referred to as ketoacidosis, or DKA. When you have ketoacidosis, you will feel very unwell, and might be dehydrated, or vomiting. Ketoacidosis needs to be treated in a hospital.

In this survey, we are interested in hearing about your experiences with raised ketone levels (ketosis) – that is – when you have ketones in your blood and you need to take treatment, but your ketone levels aren't so high that you have developed ketoacidosis.

  1. Do you check your [your child's] ketone levels with blood or urine ketone strips?

□  Blood

□  Urine

□  Both, but I use the blood strips more often

□  Both, but I use the urine strips more often

  1. The most recent time your [your child's] ketones were raised

What do we mean by "raised ketone levels"?

If your body doesn't have enough insulin, it will start breaking down fat, rather than sugar, for energy. When fat breaks down, ketones are formed, and these ketones build up in your blood and leave the body in your urine.

When ketones are in your blood or urine, you have raised ketone levels, known as ketosis. You can treat ketosis by giving yourself an extra dose of insulin and drinking lots of fluids. You might treat ketosis at home on your own, or you might seek some help from a healthcare professional.

If you don't realise you have ketones in your blood, and give yourself treatment, the ketones will continue to build up until there are so many in your blood that your body becomes acidotic. You might have heard this referred to as ketoacidosis, or DKA. When you have ketoacidosis, you will feel very unwell, and might be dehydrated, or vomiting. Ketoacidosis needs to be treated in a hospital.

In this survey, we are interested in hearing about your experiences with raised ketone levels (ketosis) – that is – when you have ketones in your blood and you need to take treatment, but your ketone levels aren't so high that you have developed ketoacidosis.

  1. How many months ago did you [your child] most recently have raised ketones?

□  _ _ month(s) ago

  1. While your [your child's] ketones were raised, how many of your ketone strips did you use?

□  _ _ _ ketone strips

  1. While your [your child's] ketones were raised, how many of your glucose strips did you use?

□  _ _ _ glucose strips

  1. Phone calls for assistance while you [your child] had raised ketones
  1. Did you make a phone call to a medical professional while your [your child's] ketones were raised?

Please select 'yes' even if you attempted to make a call but didn't manage to get through to anybody, or if you were only able to leave an answerphone message.

□  Yes

□  No, I didn't feel I needed to (à Skip to question 16)

□  No, because it was outside of working hours (à Skip to question 16)

□  No, because I don't have any access to medical professionals via phone (à Skip to question 16)

□  No, it's not something I've ever thought of doing (à Skip to question 16)

□  No, I went and saw a medical professional in person instead (à Skip to question 16)

□  No, for another reason (à Skip to question 16)

  1. How many different phone numbers did you call?

□  1

□  2

□  3

□  Four or more

  1. Who did you phone?

□  The diabetes clinic

□  My [My child's] diabetes nurse (direct number, for example, mobile number)

□  The diabetes ward at my [my child's] hospital

□  The general hospital phone number

□  My GP

□  NHS 111

□  Pump manufacturer

□  999

□  The Diabetes UK phone service

  1. Was the phone call within standard office hours? (Approximately 9am–5pm, Monday–Friday)

□  Yes

□  No

  1. How many phone calls did you make and/or receive to this number?

□  _ _ phone calls

  1. How long, in total, were you on the phone to that number?

□  Less than 5 minutes

□  5–15 minutes

□  15–30 minutes

□  30 minutes–60 minutes

□  Over 1 hour

  1. Why did you make that phone call?

□  For reassurance

□  For treatment advice

□  I had tried treating myself [my child] at home, but it wasn't working

□  To find out whether I should go [take my child] to hospital

□  Other

  1. What help did you receive?

□  Reassurance

□  Treatment advice

□  Advised to go to the clinic/hospital

□  None, I couldn't get through

□  Other

□  None, they couldn’t help

  1. Treatment at home
  1. Did you give yourself [your child] additional insulin for the raised ketones while you were at home?

□  Yes

□  No (à Skip to question 46)

  1. In total, how much additional insulin did you give yourself [your child] for the raised ketones? Please give your answer in number of units.

□  _ _ unit(s)

  1. Did you do a pump set change to try and treat your [your child's] raised ketones?

□  Yes

□  No

□  Not applicable, I do not use [my child does not use] an insulin pump.

  1. Help from healthcare professionals in person
  1. Did you go and see a healthcare professional in person to get help for your [your child's] ketones?

□  Yes

□  No (à Skip to question 23)

  1. Where did you go? If you went to more than one, please select the place you received the majority of your treatment.

□  A&E

□  Hospital ward via A&E

□  Hospital ward direct (not via A&E)

□  Diabetes clinic

□  Walk-in clinic

□  GP

□  A healthcare professional came to me

□  Other

  1. How did you get there?

□  I drove/ somebody drove me

□  Taxi

□  Public transport

□  Ambulance

□  Other

  1. Why did you seek help in-person?

□  I didn't know how to treat it myself

□  I didn't feel comfortable treating it myself

□  I had tried treating it myself, but it wasn't working

□  I was worried I [my child] might develop ketoacidosis

□  It was out of hours, so I couldn't phone a healthcare professional

□  I had tried phoning a healthcare professional but I couldn't get hold of anyone

□  I spoke to a healthcare professional on the phone and they advised I seek help in-person

□  Other

  1. After the event – Continued monitoring

In the following questions, please think about the time after your [your child's] ketone levels had returned to normal.

If you visited the hospital for treatment, think about what you did after you had gone home.

  1. After your [your child's] ketone levels had returned to normal, did you continue to monitor your [your child's] ketone levels for a while?

□  Yes

□  No (à Skip to question 25)

  1. How many ketone strips did you use while you continued to monitor your [your child's] ketone levels, after your [your child's] ketone levels had returned to normal?

□  _ _ ketone strips

  1. After your [your child's] ketone levels had returned to normal, did you continue to monitor your [your child's] glucose levels more frequently than usual?

□  Yes

□  No (à Skip to question 33)

  1. How many additional glucose strips did you use while monitoring your [your child's] glucose levels at a greater frequency than usual? For example, if you usually check your glucose 5 times a day, but instead you checked it 8 times a day, your answer would be 3.

□  _ _ strips

  1. After the event – Follow-up phone calls
  1. After your [your childs] ketone levels had returned to normal, did you have a follow-up conversation with a healthcare professional on the phone?

□  Yes, a diabetes nurse