Recommendations
A high level of cooperation and engagement is required among the following stakeholders. Specifically, we recommend:
1. Regulatory agencies should:
 a) Introduce a systematic, independent, and structured premarketing and postapproval evaluation of the performance of CGM systems including assessment of “human factors”
 b) Promote the development of a consensus on which parameters should be analyzed and reported to characterize the performance of a CGM system
 c) Specify a standardized CGM output format for reporting time in range and hypoglycemia for use in clinical trials
 d) Review available outcome measures (including patient-related outcomes) and specify those best used in CGM and AID studies
 e) Assess available models for cost–benefit calculations and specify which should be used for CGM studies
 f) Rapidly and transparently disseminate safety-related data reports on CGM to health care professionals
 g) Protect the security and confidentiality of patient data in the era of connectivity
2. Manufacturing companies should:
 a) Cooperate to standardize output formats and software used for analysis
 b) Provide interfaces that can be personalized according to the needs of the user
 c) Report all safety-related data transparently to the regulatory authorities
 d) Cooperate with academia and health care professionals to provide balanced and adequate information to people with diabetes and package the output data in standardized formats to make it easy for major electronic health record companies to access and incorporate for clinical use
 e) Incorporate a wider range of existing outcome measures including patient-reported outcomes in study designs of adequate statistical power
 f) Publish all relevant data/information collected during the clinical development of a given CGM system, e.g., the results of human factors studies
 g) Communicate frequently and regularly with users, user groups, and families affected by diabetes in order that real needs can be identified and promptly addressed as soon as the relevant technology becomes available (e.g., remote monitoring)
 h) Observe high standards of data security and patient confidentiality
3. Researchers/academics should:
 a) Develop better algorithms to improve the performance of CGM and AID systems
 b) Openly report and share the patient-level results of all clinical studies
 c) Develop and validate specific and appropriate patient-related outcome measures
 d) Develop better models for cost–benefit analyses (in partnership with industry and regulatory bodies)
 e) Work to develop and perform studies that fill genuine “gaps” in the evidence
 f) Follow the recommendations made by Pickup (33) when interpreting or performing meta-analyses
 g) Involve people with diabetes and their family members/caregivers in the development of CGM and AID systems for guidance and feedback
4. Research funding bodies should:
 a) Fund fewer small, underpowered studies of specific devices; instead fund well-designed larger “class” studies with clinically relevant end points using more than one CGM system and including head-to-head comparisons
 b) Fund large independent registry studies
5. Patient groups, health professionals, and medical associations should:
 a) Provide and regularly update recommendations on CGM
 b) Provide minimum standards of training for providers and people with diabetes using CGM, isCGM, and AID
 c) Work to develop and disseminate structured company-independent education programs, e.g., SPECTRUM, and standardized output of glucose metrics and glucose and insulin profiles, e.g., Ambulatory Glucose Profile (AGP)
 d) Work together (American Association of Clinical Endocrinologists, American Association of Diabetes Educators, ADA, EASD, Endocrine Society, International Diabetes Federation, International Society for Pediatric and Adolescent Diabetes, JDRF, and other patient advocacy groups) to provide wider access to CGM for all people with diabetes who are willing and able to use these devices on a near-daily basis
6. Consumers of CGM technology—patients, family members, caregivers—should:
 a) Report device errors and malfunctions to the manufacturers and appropriate regulatory agencies
 b) Provide input to the policy development processes of professional and patient advocacy associations and regulatory authorities
 c) Advocate for standardization and improved accessibility of CGM safety data to facilitate product comparisons