Training Decay for Medical Products: Insulin Pump Usability Study (CDER)

11/16/21, 10:57 AM

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

End of Study Questionnaire Insulin Pump
Usability Study (OMB Control Number:
0910-0847, Expiration Date: 12/31/2022)
Next, I would like to have you look at some health information and then answer a few
questions about that information. It is expected that this should take approximately 4-10
minutes.

Please note that these questions have no impact on your eligibility, token of appreciation, and
are for informational purposes only.

1.

Participant ID (the Moderator will enter this)

Nutritional
Facts Survey

Please note that these questions have no impact on your eligibility for token of
appreciation and are for informational purposes only.

The image below shows information on the back of a container of a pint of ice cream.
Using this image provided, please answer the following questions. You may use the
calculator made available to you if needed for any of the questions.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

1/20

11/16/21, 10:57 AM

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Ice Cream Nutritional Facts:

2.

The image above shows information on the back of a container of a pint of ice
cream. If you eat the entire container, how many calories will you eat?
Please enter a numerical value (no commas or decimals)

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

2/20

11/16/21, 10:57 AM

3.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

If you are allowed to eat 60 grams of carbohydrates as a snack, how many cups of
ice cream could you have?
Please select the value in cups from the dropdown list

Mark only one oval.
None
1/4 cup
1/2 cup
3/4 cup
1 cup
1 and 1/4 cups
1 and 1/2 cups
1 and 3/4 cups
2 cups
2 and 1/4 cups
2 and 1/2 cups
2 and 3/4 cups
3 cups
3 and 1/4 cups
3 and 1/2 cups
3 and 3/4 cups
4 cups

4.

Your doctor advises you to reduce the amount of saturated fat in your diet. You
usually have 42g of saturated fat each day, which includes one serving of ice
cream. If you stop eating ice cream, how many grams of saturated fat would you
be consuming each day?
Please enter a numerical value (no commas or decimals)

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

3/20

11/16/21, 10:57 AM

5.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

If you usually eat 2,500 calories in a day, what percentage of your daily value of
calories will you be eating if you eat one serving?
Please enter a numerical value (no commas or decimals, no percentage sign)

6.

Pretend that you are allergic to the following substances: penicillin, peanuts, latex
gloves, and bee stings. Is it safe for you to eat this ice cream?
Mark only one oval.
Yes
No
Not sure

7.

(if you answered no to the question above) What allergy would make it unsafe to
each this ice cream?
Mark only one oval.
Penicillin allergy
Peanut allergy
Latex glove allergy
Bee sting allergy

Additional

Please note that these questions have no impact on your eligibility for a token of
appreciation and are for informational purposes only.

Demographics

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

4/20

11/16/21, 10:57 AM

8.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Sex
Mark only one oval.
Male
Female
Prefer not to answer

9.

10.

What is your age?

What is your highest level of education?
Mark only one oval.
High school
Some college
Associate degree
Bachelor's degree
Master's degree
Doctorate degree
Other:

11.

What is your race? Mark one or more
Check all that apply.
White
Black or African American
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

5/20

11/16/21, 10:57 AM

12.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Are you Hispanic, Latino, or Spanish origin?
Mark only one oval.
Yes
No

13.

Is English your first language?
Mark only one oval.
Yes
No

14.

If English is not your first language, what language is?

15.

Which is your dominant hand?
Mark only one oval.
Right
Left
Ambidextrous

16.

Do you normally wear glasses or contact lenses?
Mark only one oval.
Yes, and I had them available for the study session(s)
Yes, and I did NOT have them available for the study session(s)
No

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

6/20

11/16/21, 10:57 AM

17.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Are you color blind?
Mark only one oval.
Yes
No
Not sure

18.

Before this study, do you have experience using drug delivery products (e.g.
syringes, autoinjectors) on yourself or others?
Mark only one oval.
Yes
No
Other:

19.

Before this study, have you ever prepared or given insulin injections to yourself
or anyone else?
Mark only one oval.
Yes
No
Other:

20.

Before this study, have you ever used an insulin pump?
Mark only one oval.
Yes
No
Other:

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

7/20

11/16/21, 10:57 AM

21.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Do you know anyone involved in this research project? Or have you read about
it?
Mark only one oval.
Yes
No
Other:

22.

How tired are you feeling today?
Mark only one oval.
1 - Not at all tired
2 - Slightly tired
3 - Moderately tired
4 - Very tired
Option 5

23.

At the start of the study session, what level of stress were you feeling?
Mark only one oval.
1 - Not at all stressed
2 - Slightly stressed
3 - Moderately stressed
4 - Very stressed
5 - Extremely stressed

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

8/20

11/16/21, 10:57 AM

24.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

During the study session today, what level of stress were you feeling?
Mark only one oval.
1 - Not at all stressed
2 - Slightly stressed
3 - Moderately stressed
4 - Very stressed
5 - Extremely stressed

Questions if you
participated in
training

25.

Note: These next questions are only applicable if you participated in two study
sessions. If you only participated in one session, please proceed to "Next"

(if you participated in training) Has your level of stress changed from the start of
the training to the start of the usability evaluation session?
Mark only one oval.
1 - Much worse
2 - Somewhat worse
3 - Stayed the same
4 - Somewhat better
5 - Much better

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

9/20

11/16/21, 10:57 AM

26.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

(if you participated in two study sessions) How tired were you feeling today
during the training compared to how you felt during the usability evaluation
session?
Mark only one oval.
1 - Much worse
2 - Somewhat worse
3 - Stayed the same
4 - Somewhat better
5 - Much better

27.

(if you participated in a study sessions with a 1-hour break) What did you do
during your break? Check all that apply.
Check all that apply.
Checked emails or texts
Played games on my phone
Read a book or magazine
Watched a show / movie
Worked on documents on a computer
Surfed the web
Talked on the phone
Other:

Ease of
Use
Ratings
(as time
permits)

Please rate the ease of each task performed from 1 - Very Difficult to 5 - Very Easy. If you
did not perform the task described, please choose "I did not perform this task." Please rate
these tasks based on initial intuition and do not think too hard about any task rating.

If you are out of time for your session, please submit the previous sections and let the
Moderator know.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

10/20

11/16/21, 10:57 AM

28.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Clean the vial septum with an alcohol pad
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

29.

Open the reservoir packaging
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

30.

Extend reservoir plunger rod
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

11/20

11/16/21, 10:57 AM

31.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Attach transfer guard/reservoir to the vial

Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

32.

Press down on the plunger to pressurize the vial
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

33.

Flip the vial over and pull the plunger to fill the reservoir
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

12/20

11/16/21, 10:57 AM

34.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Tap the reservoir to remove air bubbles and fill the reservoir to the desired
volume
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

35.

Disconnect the reservoir from the transfer guard after filling
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

36.

Disconnect the transfer guard from the vial and dispose of the transfer guard
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

13/20

11/16/21, 10:57 AM

37.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Connect the reservoir to the infusion set
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

38.

Remove air bubbles from the reservoir after connecting to the infusion set
tubing
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

39.

Disconnect (untwist) the plunger from the reservoir
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

14/20

11/16/21, 10:57 AM

40.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Insert the reservoir into the pump
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

41.

Fill the infusion set tubing
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

42.

Select the injection site
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

15/20

11/16/21, 10:57 AM

43.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Wash hands or use hand sanitizer
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

44.

Clean the injection site with an alcohol pad
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

45.

Place the infusion set into the insertion device
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

16/20

11/16/21, 10:57 AM

46.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Remove the adhesive backing from the infusion set
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

47.

Pull back handle on the insertion device to set the insertion device
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

48.

Remove the needle guard from the infusion set
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

17/20

11/16/21, 10:57 AM

49.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Insert infusion set using the insertion device
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

50.

Secure the adhesive to the skin
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

51.

Remove needle from infusion set
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

18/20

11/16/21, 10:57 AM

52.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Place guard on and dispose of needle hub
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

53.

Fill the cannula
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

54.

Program basal rates
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

19/20

11/16/21, 10:57 AM

55.

End of Study Questionnaire Insulin Pump Usability Study (OMB Control Number: 0910-0847, Expiration Date: 12/31/2022)

Remove and dispose of the infusion set and reservoir
Mark only one oval.
1- Very difficult
2- Difficult
3- Neutral
4- Easy
5- Very Easy
I did not perform this task.

This content is neither created nor endorsed by Google.

 Forms

https://docs.google.com/forms/d/1IFHIXsYzcfKcAvZJ1QyG5-KJMW2KGwHbIgiKPblzNpE/edit

20/20