Dear Delphi participants,

Thank you so much for agreeing to participate in this diabetes-related patient reported outcomes (PRO) Delphi process, which is a component of our FDA-funded Real World Evidence Project (Grant Number: 1P50FD006425-01, PI: Espinoza).  

The overall aim of our project is to build a real-time, prospective data platform that collects clinical data, device data, and patient reported outcomes for pediatric patients with Type 1 Diabetes (T1DM). This data platform will then be operationalized for clinical, research, and regulatory activities (Read more about the Real World Evidence Project Here)

The specific aim of this Delphi process is to recognise experts’ opinions on disease- and device-specific PROs in children with T1DM who use continuous glucose monitoring (CGM), and select appropriate instruments for inclusion in our data platform. To facilitate this process, our research team has conducted an extensive literature search and key informant interviews to identify relevant PROs. These PROs have been grouped into 5 domains relevant to this research project:

  1. Diabetes Related Distress and Burden
  2. Technology Acceptance
  3. General Health and Quality of Life (QoL)
  4. Psychosocial Factors
  5. Patient/Parent Autonomy

At the end of this process we hope to assemble a battery of instruments to collect patient reported outcomes. These instruments will be deployed at different times, and under different circumstances, which can be summarized into three categories:

  1. PRO measures (proposed periodicity: monthly)
    1. Examples: Skin Integrity, Pain/comfort, knowledge/management
  2. Ecological Momentary Assessment
    1. Event Contingent (ED or hospital visit)
    2. Signal Contingent (new labs, new documentation, random)
    3. Time Contingent (biweekly)
  3. Other Study Metrics (proposed periodicity: Q2-3 months)
    1. Examples: Quality of life, Mental/Emotional Health, Self-efficacy

About this Delphi Process

The Delphi Process will consist of 3 rounds of feedback, all conducted online and asynchronously using this website. Round 1 will be to provide your opinion on PROs, round 2 will be structuring and categorizing your responses and round 3 will be rating the responses and reaching consensus. Your response will remain anonymous to other experts to allow free expression of opinions. All participating experts will be acknowledged in the project report and will receive a copy of the report at the end of the study. The final recommendations of this Delphi process will then be presented to a panel of patient and parent advisors, who will provide feedback and choose the final instruments for study inclusion.

Time Commitment

We realize that you are extremely busy, and we are grateful for your participation. In practical terms, the time commitment we are asking for is roughly 3 one-hour sessions over the course of 3 months. If you find yourself needing additional time, please let us know and we will try to accommodate your schedule. If you are unable to continue participating, please let us know as well so that we can adjust our protocol accordingly. Please do not hesitate to contact us if you require further information.

Thank you again, and looking forward to working with you,


Juan Espinoza, MD

Principal Investigator


Payal Shah, MS, CCRP

Research Associate


Jennifer Raymond, MD, MCR