New recommendations from two major diabetes organizations aim to overcome the barriers that have kept continuous glucose monitoring (CGM) technologies from achieving their potential to "revolutionize" intensive insulin therapy.
Clinical evidence
Growing evidence supports the benefits of using CGM: the studies and clinical trials reviewed below suggest that adults with type 1 diabetes who wear a CGM device most days can improve glycaemic control without increasing risk of hypoglycaemia, while those already close to target HbA1c can maintain control while reducing risk of hypoglycaemia. In children and adolescents, achieving adequate adherence remains a significant barrier, although usability has improved with current-generation CGM devices in this age group [2b].
"Improving the clinical value and utility of CGM systems: Issues and recommendations: A joint statement of the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group" was published online October 25, 2017 in Diabetes Care and in Diabetologia
The authors were a panel led by John R Petrie, of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, Scotland. The same group published a statement on insulin-pump safety in 2015.
Despite "great progress" in CGM technology in recent years, Dr Petrie and colleagues write, "insufficient evidence of clinical utility and reliability and the lack of consistent reimbursement contribute to limited use of CGM across large populations of people with diabetes who could potentially benefit.
"A more concerted commitment to seeking robust evidence by industry, regulators, clinical and technical experts, and funding and patient organizations is required for the necessary trials to be conducted and for the field to progress," they stress.
This will include the incorporation of CGMs as key components of automated insulin-delivery systems and their intermediate iterations, including sensor-augmented insulin pumps and "hybrid" closed-loop systems.
The document summarizes the considerable data showing benefit of traditional CGMs — as well as the FreeStyle Libre , a so-called "flash" monitoring system that is termed "intermittently scanned CGM" (isCGM) — in patients with type 1 diabetes and the more limited data suggesting benefit for some patients with type 2 diabetes who use insulin.
Despite Considerable Trial Data on CGMs, Much More Research Needed
However, the authors point out several limitations to the numerous studies conducted so far, including few participants with recent history of severe hypoglycemia, lack of head-to-head comparisons between CGM and isCGM systems, lack of standardization in outcomes, and insufficient guidance for patients on how to use the CGM data to make therapeutic decisions.
Moreover, they contend, these weaknesses in the data, along with a dearth of cost/benefit studies, are partly responsible for the heterogeneity in reimbursement for the technologies in the United States and Europe.
The document makes 31 specific recommendations aimed at the relevant stakeholders — regulatory agencies, manufacturers, researchers/academics, research funding bodies, patient groups, health professionals, and medical associations — and falling under five main themes:
1. More systematic and structured premarketing evaluation of the performance of CGM systems.
2. Greater investment in trials to provide evidence of CGM value and reliability for all patient groups.
3. Standardization of CGM-measured glucose data reporting from clinical trials.
4. Improved consistency and accessibility of safety reports to regulatory authorities after market approval.
5. Increased communication and cooperation across stakeholder groups.
"We envision an ongoing role of the [American Diabetes Association, the European Association for the Study of Diabetes], and other professional medical associations in supporting the virtuous cycle of CGM innovation, confirmation of value to users, increased utilization, and greater resources reinvested to support innovation," the panel writes.
They add, "For this vision to be realized without further delay, we call upon regulators and manufacturing companies to work urgently with health professionals and people with diabetes to create an environment with much greater standardization of outcome measures, a high level of attention to safety issues, and full transparency of adverse-event reporting."
Diabetes Care. Published online October 25, 2017.  Article
Abstract The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world
Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM
This scientific statement was reviewed and approved by the American Diabetes Association Professional Practice Committee and the EASD Committee on Clinical Affairs in May 2017 and ratified by the American Diabetes Association Board of Directors and the Executive Committee of the EASD in May 2017.
This article is being simultaneously published in Diabetes Care and Diabetologia by the American Diabetes Association and the European Association for the Study of Diabetes.
This scientific statement makes recommendations for systemic improvements in clini-cal use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achiev- ing its potential to improve quality of life and health outcomes for more people with diabetes.
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Diabetologia. Published online October 25, 2017. Article
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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 analysed and reported to characterise the performance of a CGM system
c) Specify a standardised CGM output format for reporting time in range and hypoglycaemia 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 healthcare professionals
g) Protect the security and confidentiality of patient data in the era of connectivity
2. Manufacturing companies should:
a) Cooperate to standardise output formats and software used for analysis
b) Provide interfaces that can be personalised according to the needs of the user
c) Report all safety-related data transparently to the regulatory authorities
d) Cooperate with academia and healthcare professionals to provide balanced and adequate information to people with diabetes and package the output data in standardised 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 endpoints 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 standardised 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 standardisation and improved accessibility of CGM safety data to facilitate product comparisons