Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms

Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary

The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.

Inclusion Criteria:

1. Subject has Type 1 or Type 2 diabetes mellitus
2. Subject is 18 to 70 years old
3. Subject has chronic, active symptoms of gastroparesis for at least the past three months
4. Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule
5. Subject can speak and read English
6. Subject is able to give his/her informed consent

Exclusion Criteria:

1. Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit

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