Development and Content Validation of the Insulin Pump Infusion Sets Satisfaction Scale (IPISS): A Self-Reported Questionnaire for Patients with Type 1 Diabetes and Caregivers
Abstract
1. Introduction
Patient-Reported Outcomes (PROs) Relevance
2. Materials and Methods
2.1. Questionnaire Design
- A patient self-report version, intended for patients aged 12 years or older, considered able to complete the questionnaire independently.
- A caregiver version, to be completed by parents or caregivers when the patient is under 12 years of age or not capable of reliable self-reporting.
2.2. Content Validation Procedure
- Not relevant/not clear;
- Somewhat relevant/somewhat clear;
- Quite relevant/clear;
- Highly relevant/very clear.
2.3. Face Validity Evaluation
3. Results
3.1. Content Validity
3.1.1. First Round of Evaluation
- A copyright symbol (®) was added to each branded infusion set name (e.g., Medtronic Extended®, Autosoft 30®).
- The order of the questions was revised to enhance thematic continuity: the original item 17 (on skin reactions) was moved to position 12 to be grouped with related items.
- Minor spelling and formatting corrections were applied to improve consistency.
3.1.2. Second Round of Evaluation
3.1.3. Scale-Level Validity
3.2. Face Validity
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
IPISS | Insulin Pump Infusion Sets Satisfaction Scale |
PROs | Patient-Reported Outcomes |
I-CVI | Item Content Validity Index |
S-CVI | Scale Content Validity Index |
T1D | Type 1 Diabetes |
CSII | Continuous Subcutaneous Insulin Infusion |
CGM | Continuous Glucose Monitoring |
AID | Automated insulin delivery |
FDA | Food and Drug Administration |
ITSQ | Insulin Treatment Satisfaction Questionnaire |
IDSRQ | Insulin Delivery System Rating Questionnaire |
IDSS | Insulin Device Satisfaction Survey |
INSPIRE | INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations |
IPA | Insulin Pump Attitudes questionnaire |
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Section | Description of Thematic Area |
---|---|
1. Demographics and Usage | Age group, type of infusion set used, and preferred insertion sites |
2. Infusion Set Management | Frequency and duration of set changes, and level of autonomy in managing set changes |
3. Problems and Complications | Difficulties encountered during set use, including pain, discomfort, and insertion ease |
4. Skin Reactions | Occurrence, type, and timing of dermatological reactions related to set use |
5. Adhesion and Glycemic Impact | Frequency of early set changes due to adhesive failure, hyperglycemia, leakage, or bleeding |
6. Global Satisfaction | Overall satisfaction score and open comments on set performance and user experience |
Introduction | This questionnaire aims to collect the experience and satisfaction of patients or parents/caregivers with insulin infusion sets, the devices that connect the pump to the body through a small cannula inserted under the skin. |
Question | Possible Answers |
0. How old is the patient? |
If the patient is 12 years or older, the PATIENT completes the questionnaire. |
Caregiver questionnaire | |
1. Which infusion set does the patient use? |
|
2. What is the patient’s most frequently used placement * site? * insertion on skin |
|
3. If multiple insertion sites are used, which others? (multiple answers allowed) |
|
4. How often is the infusion set usually changed? |
|
5. How much time is usually needed to change the set? |
|
6. Does the patient change the set independently? |
|
7. How often are there problems during set change requiring a new set within 24 h? |
|
8. How easy is it to place * the infusion set? * insert on skin | Visual scale from 1 (very difficult) to 10 (very easy) |
9. How painful is the infusion set placement * for the patient? * insertion on skin | Visual scale from 1 (no pain) to 10 (very painful) |
10. How uncomfortable is the set once in place *? * once inserted on skin | Visual scale from 1 (no discomfort) to 10 (very uncomfortable) |
11. Has the infusion set ever caused a skin reaction in the patient? |
If No, go to question 12. |
11a. What type of skin reaction? (multiple answers allowed) |
|
11b. How often does the skin reaction occur? |
|
11c. When is the reaction noticed? |
|
12. How often do you need to replace the infusion set before its intended replacement time due to a skin reaction? |
|
13. How often do you need to replace the infusion set before its intended replacement time due to poor adhesive retention? |
|
14. How often do you need to use extra adhesive products to keep the infusion set attached to the skin? |
|
15. How often do you need to replace the infusion set before its intended replacement time due to unexplained persistent hyperglycemia *? * high blood glucose for a long time without knowing why |
|
16. How often do you need to replace the infusion set before its intended replacement time due to insulin leakage/loss? |
|
17. How often do you need to replace the infusion set before its intended replacement time due to bleeding? |
|
18. Overall, how satisfied are you with the infusion set used? | Visual scale from 1 (not at all satisfied) to 10 (very satisfied) |
19. Additional comments on the infusion set | Free text |
Patient questionnaire | |
1. Which infusion set do you use? |
|
2. What is your most frequently used placement * site? * insertion on skin |
|
3. If you use multiple sites, which others? (multiple answers allowed) |
|
4. How often do you usually change the infusion set? |
|
5. How long does a set change usually take? |
|
6. Do you change the set by yourself or with someone’s help? |
|
7. How often do you have problems that require changing the set within 24 h? |
|
8. How easy is it to place * the infusion set? * insert on skin | Visual scale from 1 (very difficult) to 10 (very easy) |
9. How painful is the infusion set placement * for you? * insertion on skin | Visual scale from 1 (no pain) to 10 (very painful) |
10. How uncomfortable is the set once in place *? * once inserted on skin | Visual scale from 1 (no discomfort) to 10 (very uncomfortable) |
11. Has the infusion set ever caused a skin reaction for you? |
If No, go to question 12. |
11a. What kind of skin reaction? (multiple answers allowed) |
|
11b. How often does the skin reaction happen? |
|
11c. When do you notice the skin reaction? |
|
12. How often do you need to replace the infusion set before its intended replacement time due to a skin reaction? |
|
13. How often do you need to replace the infusion set before its intended replacement time due to poor adhesive retention? |
|
14. How often do you need to use extra adhesive products to keep the infusion set attached to the skin? |
|
15. How often do you need to replace the infusion set before its intended replacement time due to unexplained persistent hyperglycemia *? * high blood glucose for a long time without knowing why |
|
16. How often do you need to replace the infusion set before its intended replacement time due to insulin leakage/loss? |
|
17. How often do you need to replace the infusion set before its intended replacement time due to bleeding? |
|
18. Overall, how satisfied are you with the infusion set you use? | Visual scale from 1 (not at all satisfied) to 10 (very satisfied) |
19. Additional comments on the infusion set | Free text |
Version | Round | I-CVI (Min) | I-CVI (Max) | Items with I-CVI < 0.833 | S-CVI |
---|---|---|---|---|---|
Patient | Round 1 | 0.83 | 1.00 | 1 | 0.9924 |
Caregiver | Round 1 | 0.83 | 1.00 | 1 | 0.9924 |
Patient | Round 2 | 1.00 | 1.00 | 0 | 1.00 |
Caregiver | Round 2 | 1.00 | 1.00 | 0 | 1.00 |
Version | Round | I-CVI (Min) | I-CVI (Max) | Items with I-CVI < 0.833 | S-CVI |
---|---|---|---|---|---|
Patient | Round 1 | 0.83 | 1.00 | 1 | 0.9924 |
Caregiver | Round 1 | 0.83 | 1.00 | 2 | 0.9848 |
Patient | Round 2 | 1.00 | 1.00 | 0 | 1.00 |
Caregiver | Round 2 | 0.833 | 1.00 | 1 | 0.9924 |
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Share and Cite
Del Monte, M.; Spacco, G.; Pintabona, A.; Siri, G.; Parodi, S.; Gambarelli, F.; Poirè, E.; Minuto, N.; Bassi, M. Development and Content Validation of the Insulin Pump Infusion Sets Satisfaction Scale (IPISS): A Self-Reported Questionnaire for Patients with Type 1 Diabetes and Caregivers. Diabetology 2025, 6, 110. https://doi.org/10.3390/diabetology6100110
Del Monte M, Spacco G, Pintabona A, Siri G, Parodi S, Gambarelli F, Poirè E, Minuto N, Bassi M. Development and Content Validation of the Insulin Pump Infusion Sets Satisfaction Scale (IPISS): A Self-Reported Questionnaire for Patients with Type 1 Diabetes and Caregivers. Diabetology. 2025; 6(10):110. https://doi.org/10.3390/diabetology6100110
Chicago/Turabian StyleDel Monte, Marco, Giordano Spacco, Andrea Pintabona, Giulia Siri, Stefano Parodi, Filippo Gambarelli, Elena Poirè, Nicola Minuto, and Marta Bassi. 2025. "Development and Content Validation of the Insulin Pump Infusion Sets Satisfaction Scale (IPISS): A Self-Reported Questionnaire for Patients with Type 1 Diabetes and Caregivers" Diabetology 6, no. 10: 110. https://doi.org/10.3390/diabetology6100110
APA StyleDel Monte, M., Spacco, G., Pintabona, A., Siri, G., Parodi, S., Gambarelli, F., Poirè, E., Minuto, N., & Bassi, M. (2025). Development and Content Validation of the Insulin Pump Infusion Sets Satisfaction Scale (IPISS): A Self-Reported Questionnaire for Patients with Type 1 Diabetes and Caregivers. Diabetology, 6(10), 110. https://doi.org/10.3390/diabetology6100110