Thanks for the opportunity to comment on this important new chapter to the ISPAD guidelines ‘stable’
I note the previous comments / suggestions already posted on this chapter.
I’d like to highlight the following for consideration / clarification:
1. Conflict of interest statement
This is always a rather tricky / sensitive issue - but one that is nevertheless very relevant to this this chapter given its subject matter. I believe that all of the authors listed are significantly involved in either supporting or leading diabetes technology research programmes. The authors may therefore be perceived as having a ‘vested interest’ and therefore potentially ‘conflicted’.
I suggest that for the sake of transparency and openness that a conflict of interest statement for each contributing author should be included at the beginning of this chapter. This should clarify the grant funding / support received for their research in this area - from both charitable and industry sources. Also the usual relationships with industry partners should be clarified (honoraria; lectures etc…), including whether they hold shares in any of these companies; hold intellectual property (IP) rights or patents in the area of diabetes technologies.
2. Executive summary.
a. “CSII reduces chronic complications of T1D in youth, despite similar hemoglobin A1C (HbA1c) achieved in those on multiple daily injection (MDI) therapy (B)”
As far I can ascertain, this statement is based on observations made by one study. I am therefore not convinced that this merits inclusion in the executive summary, certainly not as currently written.
Whilst the evidence rating assigned to this statement - B - may be correct, it is only based on the results from a single study. The statement should be either removed or, at least, rephrased. If the latter I suggest - “CSII has been shown in one study to be associated with a reduction in chronic complications of T1D in youth, despite similar hemoglobin A1C (HbA1c) achieved in those on multiple daily injection (MDI) therapy (B)”
b.“Sensor augmented pump (SAP) therapy is superior in children and adolescents over MDI with self-monitoring of blood glucose (SMBG) in reduction of HbA1c without an increase in hypoglycemia or severe hypoglycemia (A)” -
This statement seems a bit overstated given the body of evidence presented (mainly extrapolated from the STAR3 trial), the fact that SAP ‘success’ is heavily dependent on the amount of sensor usage, and that it is not supported so far by ‘real world’ observations. Suggest rephrase / moderate - appropriately
3. Section 3 - Page 4 & 5
a. “Furthermore, data from meta-analyses conducted by various groups have depicted similar findings with pump therapy”.
I am not sure this is entirely true /correct. The authors appears to have overlooked other - perhaps more robust / rigorous - meta-analyses undertaken to those cited that have different conclusions. For example Yeh , et al. Ann Intern Med. 2012;157(5):336-47
b. The discussion regarding the pooled analyses from the DPV / T1DX and NPDA paper (Sherr et al, Diabetologia 2016) - should address / acknowledge the limitations of this study - i.e. its cross-sectional nature, etc… HbA1c values in the NPDA cohort were significantly higher than those observed in the DPV / T1Dx cohorts. Differences between CSII and MDI in the better controlled DPV and T1DX cohorts were small and perhaps of debatable ‘clinical’ significance?
d. Discussion / mention regarding the DPV “database analysis of almost 10,000 participants” (Karges et al , JAMA 2017) merits further explanation and clarification.
Why are the key data from this study not shown / highlighted here - particularly regarding HbA1c? Whilst the differences in HbA1c between CSII vs MDI in this analysis may have been statistically significant (p= <0.001) their clinical significance (8.04% vs 8.22%; difference = -0.18%) is debatable, and are unlikely to be of any significant benefit over the long-term in terms of chronic complications reductions or from a health economic perspective.
Thus the statement “Thus, the benefits of pump use have now been echoed in various registry assessments.” therefore seems, again, rather overstated and presumptive.
General comments
I wonder if the following topics / themes need specific inclusion, or in some areas, more in depth consideration and clarification:
a. Statistically significant vs clinical significant observations. Some statistically significant results may not necessarily be of clinical significance and should accordingly be interpreted with this in mind.
b. Health-economic considerations / implications. This topic is not really mentioned. What are the future challenges we face regarding the costs of diabetes technology. Does the current evidence base justify the drive to make the use of diabetes technologies the new ‘standard of care’ from a health economic perspective?
c. Access to technology - I wonder if more explicit, practical, recommendations should be made regarding who should be strongly considered / prioritised for access to diabetes technologies? This is particularly relevant given that in many health care systems access to technologies may be significantly restricted or rationed through limited funding. For example:
1. What specific clinical situations / scenarios should diabetes technologies be strongly considered / recommended or prioritised ?
Table 1 - partially addresses this issue - but only for CSII and not for CGM / SAP. Also the indications highlighted on Table 1 are very broad / vague to say the least, and are based on recommendations made in 2007. Given the evidence base has moved on since then - could these recommendations be better defined or refined and made more specific?
2. Identifying the ‘type’ of patients / families - who are likely to represent a “good fit for the device”.
Are there any specific factors / characteristics - psychological; behavioural, social etc… - that would support or preclude consideration for using a specific diabetes technology?
What factors are likely to determine success / failure? Can these be listed?
Are there any ‘tools’ / resources that could help ‘screen’ to identify patients / families who may (or may not) do well with technology.
3. There is an appropriate focus on “barriers to [technology] uptake” and recommendations to “conduct a brief assessment of barriers” and to “problem-solve”, yet no practical advice is provided as to how this should be done, other than perhaps to refer to a psychologist. However - not all (many) health care systems will have ready access to a clinical psychologist or to psychological services.