Indication - Diabetes mellitus
Facility level:
Assay formats
Glucose meter
Status history
First added in 2022
Purpose type
To self-monitor type 1 and type 2 diabetes mellitus at home
Specimen types
Capillary whole blood
WHO prequalified or recommended products
WHO supporting documents
HEARTS-D: diagnosis and management of type 2 diabetes (2020) https://apps.who.int/iris/handle/10665/331710 https://www.who.int/health- topics/diabetes#tab=tab_1
Technical specifications for procurements
This tool presents technical specifications for the glucose meter, to review it download the file and scroll down.
ICD11 code: 5A14

Summary of evidence evaluation

Evidence of the effectiveness of self-monitoring, relative to no self-monitoring or other alternatives, is scarce and of questionable validity (one case series) and applicability (association between monitoring frequency and outcomes). Available evidence, while of very low certainty, suggests that higher frequencies of self-monitoring might improve HbA1c control. Despite this lack of good quality evidence, self-monitoring appears to be widely recommended as part of routine care in diabetic patients using insulin therapy.

Summary of SAGE IVD deliberations

This edit would add a new test purpose for self-monitoring diabetes at home to the already existing glucose meter non-laboratory-based assay in the EDL. SAGE IVD considered the submission to be generally good and aligned with WHO guidelines, in particular for diabetes, for primary health care interventions and for self-health care. One expert observed that promoting self- monitoring of glucose at home with test strips will result in better control of diabetes and will also help to make support for the technology a priority at the government level. In this regard, including the test in the EDL constitutes a step towards reducing inequities. It was also noted that this application was the only one to receive considerable attention during the call for public comments phase, including two comments from people living with diabetes who provided evidence. SAGE IVD also commented on the role of the EDL in highlighting what is available and useful in the field even when it is not yet in the guidelines, especially in settings where access to clinical laboratories is limited. One point of confusion concerned a footnote included in the proposed edit to the test purpose provided by the applicant appearing to say that the test was for self-monitoring type 2 diabetes when indicated or recommended but not for type 1. SAGE IVD suggested removing the footnote to avoid misunderstanding, as the test is clearly meant for self-monitoring of both type 1 and type 2 diabetes. Literature cited in the discussion: Diabetes. In: WHO/Health topics [website]. Geneva: World Health Organization; 2022 (https://www.who.int/health-topics/diabetes#tab=tab_1 accessed 14 December 2022). HEARTS D: diagnosis and management of type 2 diabetes. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/331710, accessed 14 December 2022).

SAGE IVD recommendation

SAGE IVD recommended including the proposed edits to the test purpose of the glucose IVD test, for the glucose meter assay format in EDL 4 ■ as a disease-specific IVD for use in community settings and health facilities without laboratories (EDL 4, Section I.b); ■ using a glucose meter format; ■ using capillary whole blood as specimen type; ■ to self-monitor type 1 and type 2 diabetes mellitus at home.

Details of submission from 2022


For young people living with type 1 diabetes, daily insulin replacement is required for survival. Self-monitoring of blood glucose (SMBG) is universally recognized as the most important part of insulin therapy. Regular, daily SMBG outside of the health facility ensures that people using insulin are able to use it safely and efficaciously and helps them maintain target-range daily glucose levels, thus reducing glycated haemoglobin (HbA1c) levels and early and devastating complications, including blindness and renal failure. Life for a Child has done extensive research, with international colleagues, documenting the provision of blood glucose meters and test strips for SMBG purposes (1, 2, 3, 4) and has consistently found that access to this crucial component of care for people living with type 1 diabetes is extremely deficient in LMICs. Low rates of access to SMBG are largely due to lack of health system provision. The consequences of this include poorly controlled diabetes, high prevalence of complications and catastrophic financial impacts on patients and their families. In a 2018 paper (2) published in Lancet Diabetes & Endocrinology, Life for a Child first expressed support on seeing that glucose testing was included as a diagnostic for diabetes in the first WHO model list of essential in vitro diagnostics but argued that this ought to include SMBG supplies for long-term use in future versions. FIND together with partners has published a market report on diabetes self-monitoring devices in LMICs (5) that analyses the blood glucose test strip market and access barriers to testing supplies. Further to this work, FIND has engaged with blood glucose test strip manufacturers to improve the affordability of these products for LMICs (6), resulting in some of the lowest access pricing available to LMIC buyers today (7). The addition of “Diabetes mellitus” to the disease-specific section of the third EDL and the associated listing of blood glucose meters as IVDs recommended for use in community settings and health facilities without laboratories was welcome to raise the priority of these IVDs for availability at low levels of care, where blood glucose meters are frequently absent (8). This application is submitted with the goal of extending the list of test purposes to include specific mention of self-monitoring for people living with diabetes. The applicants believe this would further strengthen the important role these IVDs play in diabetes management and heighten awareness among stakeholders who consult the EDL to define diagnostics needs in their country. While the EDL includes terminology such as “home-based” and “self-testing”, the applicants deem the extension of the test purpose to include “self-monitoring” as critical to ensure the neglected use case of blood glucose meters and test strips for self-monitoring gets the attention that people living with diabetes need at the country level.

WHO or other clinical guidelines relevant to the test

American Diabetes Association. Standards of medical care in diabetes – 2022. J Clin Appl Res Educ. 2022;45 Suppl 1. ■ “All children and adolescents with type 1 diabetes should monitor glucose levels multiple times daily (up to 6–10 times/day by blood glucose meter or continuous glucose monitoring), including prior to meals and snacks, at bedtime, and as needed for safety in specific situations such as exercise, driving, or the presence of symptoms of hypoglycemia.” Basit A, Khan A, Khan RA. BRIGHT guidelines on self-monitoring of blood glucose. Pak J Med Sci. 2014;30(5):1150–5. ■ The high costs of test strips may render recommended guidelines unattainable for some people in low-resource settings; monitoring blood glucose at a reduced frequency and rotating daily test times can often be used productively. International Society for Pediatric and Adolescent Diabetes guidelines – Chapter 8: Glycemic control targets and glucose monitoring for children, adolescents, and young adults with diabetes. Berlin: ISPAD; 2018. ■ “Regular self-monitoring of glucose (using accurate fingerstick blood glucose [BG] measurements...is essential for diabetes management for all children and adolescents with diabetes. Each child should have access to technology and materials for self- monitoring of glucose measurements to test enough to optimize diabetes care.” ■ “When fingerstick BGs are used, testing may need to be performed 6 to 10 times per day to optimize intensive control.” ■ “Chronic hyperglycemia has adverse effects on neurocognitive function and brain structure and development in children and adolescents with diabetes. Chronic hyperglycemia and wide glucose fluctuations during the years of rapid brain development affect brain structure and development, including impairment of the growth of the hippocampus.” ■ “Hypoglycemia is also a significant risk for children and adolescents with diabetes. Severe hypoglycemia, particularly in young children, is associated with adverse neurocognitive effects.” New WHO report maps barriers to insulin availability and suggests actions to promote universal access. In: WHO/News [website]. Geneva: World Health Organization; 2021. ■ Since 2021, there have been commitments from WHO to include blood glucose test strips in the prequalification programme. ■ “The expansion of WHO’s prequalification programme to include glucose monitoring devices, test strips and diagnostic tools, and the inclusion of additional forms of insulin and other diabetes medicines in the latest update of the WHO Model Lists of Essential Medicines are expected to lead to improved access in countries where demand is currently unmet.” Ogle GD, von Oettingen JE, Middlehurst AC, Hanas R, Orchard TJ. Levels of type 1 diabetes care in children and adolescents for countries at varying resource levels. Pediatr Diabetes. 2019;20(1):93–8. ■ “All people with type 1 diabetes (T1D) deserve quality care. In countries that can afford it, comprehensive, guidelines-based care should be provided through the respective government health service. Currently, however, many less-resourced countries are only providing what we have defined as ‘minimal care,’ which has a high morbidity and mortality. We therefore encourage and recommend that less-resourced countries support ‘intermediate care,’ an approach that is substantially less expensive than comprehensive care but can still achieve markedly improved outcomes. The key components of intermediate care are human insulin in a basal bolus regimen, SMBG, point-of-care HbA1c testing, diabetes education, basic complications screening, and access to a doctor and nurse experienced in T1D care in young people.” ■ “Access to SMBG is a profound issue for improving T1D care in less-resourced settings, and national and international advocacy and innovative approaches are needed to address this issue.” Silver B, Ramaiya K, Andrew SB, Fredrick O, Bajaj S, Kalra S. East African diabetes study guidelines: insulin therapy in diabetes. Diabetes Ther. 2018;9(2):449–92. ■ “Blood glucose monitoring is an integral part of effective insulin therapy and should not be omitted in the patient’s care plan.” WHO global coverage targets for diabetes. 2022. ■ In April 2022, Member States of the World Health Assembly voted for the adoption of the WHO diabetes recommendations and coverage targets. These targets in particular include that “100% of people with Type 1 diabetes have access to affordable insulin treatment and blood glucose self-monitoring.”

Evidence for clinical usefulness and impact

Gomes MB, Tannus LRM, Cobas RA, Matheus ASM, Dualib P, Zucatti AT et al. Determinants of self-monitoring of blood glucose in patients with type 1 diabetes: a multi-centre study in Brazil. Diabet Med 2013;30:1255–62. ■ “HbA1c levels were similarly associated with SMBG frequency, although with no additional benefit beyond four tests per day.” Klatman EL, Jenkins AJ, Ahmedani MY, Ogle GD. Blood glucose meters and test strips: global market and challenges to access in low-resource settings. Lancet Diabetes Endocrinol. 2019;7(2):150–60. ■ “Diabetes is a unique medical condition with respect to the frequency of home measurements required.” ■ “Hypoglycaemia and hyperglycaemia occur acutely and frequently in people with diabetes, particularly in those who are treated with insulin. Long-term glycaemia is also a major determinant of chronic complications. Therefore, home monitoring of blood glucose with meters and test strips (self-monitoring of blood glucose [SMBG]) is widely used.” ■ “Home glucose monitoring began in the 1940–50s with urine testing, first using Benedict’s solution heated over a Bunsen burner, then effervescent tablets, and then urine test strips. SMBG was first used at home by Richard Bernstein in 1969. Since then, reflectance meters have been replaced by biosensor meters, with subsequent improvements in speed, miniaturisation, accuracy, and connectivity.” ■ The majority of blood glucose test strips used in LMICs today are utilized in health care facilities, and government procurement largely focuses on glucose testing needs in facilities. ■ The cost of test strips for people living with diabetes in LMICs is often prohibitive. This often limits SMBG to the absolute minimum for this group of people, sometimes leading them to forgo usage altogether, leading to dangerous extremes of glycaemia, highly impaired quality of life, and increased risk of developing serious and preventable metabolic complications. Klatman EL, McKee M, Ogle GD. Documenting and visualising progress towards universal health coverage of insulin and blood glucose test strips for people with diabetes. Diabetes Res Clin Pract. 2019;157:107859. ■ Provision of test strips through the health system is, for many people with diabetes, the only option to perform critically important SMBG, yet the large majority of LMIC health care systems do not provide test strips for self-monitoring. ■ In LMICs, provision of test strips is rarely covered within public health system benefit packages. ■ This study looking at provision of test strips found this number to be 14% of countries surveyed (n = 37). This is still the case in health insurance schemes, where a small percentage of the population can afford enrolment. This leaves people living with insulin-treated diabetes with no choice but to purchase test strips for SMBG out of pocket at private retail pharmacies (at a cost that can range from US$ 0.25 to US$ 1.65 (median US$ 0.49, mean US$ 0.56) for one test strip). ■ Given this lack of provision and high out-of-pocket costs for SMBG supplies, global commitments made towards Goal 3 of the United Nations’ Sustainable Development Goals, which calls on governments to ensure healthy lives and promote well-being for all at all ages, are leaving those with insulin-treated diabetes behind. Miller KM, Beck RW, Bergenstal RM, Goland RS, Haller MJ, McGill JB et al. Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013;36(7)2009–14: ■ “The advent in the 1980s of meters for self-monitoring of blood glucose (SMBG) has had a substantial impact on the management of type 1 diabetes.” ■ “SMBG is the cornerstone of modern-day therapy for people with type 1 diabetes.” ■ “Several studies have demonstrated a strong correlation between frequency of SMBG and glycemic control.” ■ “A higher number of SMBG measurements per day was strongly associated with a lower HbA1c in all age-groups.” ■ “There was no significant interaction between SMBG and household income on HbA1c levels for any age-group.” ■ “The association between SMBG and HbA1c levels appeared to level-off at approximately 10 SMBG measurements per day, with adjusted mean HbA1c being similar in participants testing 10–12 times as in those testing more than 13 times per day, 7.8 and 7.7%, respectively.” Noorani M, Ramaiya K, Manji K. Glycaemic control in type 1 diabetes mellitus among children and adolescents in a resource limited setting in Dar es Salaam – Tanzania. BMC Endocr Disord. 2016;16:29. ■ “Adherence to BGM regimen was associated with lower mean HbA1c in those with average adherence as compared to those with poor adherence.” Ogle GD, Kim H, Middlehurst AC, Silink M, Jenkins AJ. Financial costs for families of children with Type 1 diabetes in lower-income countries. Diabet Med. 2016;33(6):820–6. ■ “For people living with diabetes in LMICs, even two test strips per day for SMBG over the course of a year often outweigh the annual cost of human insulin. The cost of two strips per day for one year as a percentage of per capita gross national income (GNI) ranged from 4% in Saint Lucia to 129% in Burkina Faso. The mean cost of two strips per day was 41% of the per capita GNI, and the median cost was 24%.” Pastakia SD, Cheng SY, Kirui NK, Kamano JH. Dynamics, impact, and feasibility of self-monitoring of blood glucose in the rural, resource constrained setting of western Kenya. Clin Diabetes. 2015;33:136–43. ■ “This study shows that, despite resource challenges that can impede the performance of frequent SMBG, patients in a semi-urban and rural setting in western Kenya achieved a 4-point reduction in median A1C after 6 months of participation in an intensive SMBG and insulin adjustment program.” Ziegler R, Heidtmann B, Hilgard D, Hofer S, Rosenbauer J, Holl R et al. Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2011;12(1):11–7. ■ “There is an association between increasing SMBG use up to five times per day and reductions in HbA1c and acute complications in children and adolescents with type 1 diabetes.” ■ “Knowing the accurate blood glucose level is the only way to adjust the patient’s insulin dose, eating behavior, and physical exercise.”
1. Klatman EL, McKee M, Ogle GD. Documenting and visualising progress towards universal health coverage of insulin and blood glucose test strips for people with diabetes. Diabetes Res Clin Pract. 2019 Nov;157:107859. doi:10.1016/j.diabres.2019.107859. 2. Klatman EL, Jenkins AJ, Ahmedani MY, Ogle GD. Blood glucose meters and test strips: global market and challenges to access in low-resource settings. Lancet Diabetes Endocrinol. 2019 Feb;7(2):150–60. doi:10.1016/S2213-8587(18)30074-3. Erratum in: Lancet Diabetes Endocrinol. 2018 Aug 30. 3. Ogle GD, Kim H, Middlehurst AC, Silink M, Jenkins AJ. Financial costs for families of children with type 1 diabetes in lower-income countries. Diabet Med. 2016 Jun;33(6):820–6. doi:10.1111/ dme.12997. 4. Ogle GD, Middlehurst AC, Silink M. The IDF Life for a Child Program Index of diabetes care for children and youth. Pediatr Diabetes. 2016 Aug;17(5):374–84. doi:10.1111/pedi.12296. 5. Market report: diabetes self-monitoring devices in low-and middle-income countries. October 2021. In: HAI [website]. Amsterdam: Health Action International; 2021 (https://haiweb.org/wp- content/uploads/2021/09/Market-Report_Self-monitoring-Devices-in-LMICs.pdf, accessed 4 April 2023). 6. FIND partners with glucose test strip manufacturers to improve affordability of blood glucose self-monitoring in low- and middle-income countries. In: FIND/Publications and statements [website]. Geneva: FIND; 2022 (https://www.finddx.org/wp-content/uploads/2022/12/2021 0818_prr_glucose_test_strips_FV_EN.pdf, accessed 4 April 2023). 7. Towards insulin for all: operationalising the WHA74 resolution on diabetes. Technical Brief May 2022. Grenoble: Santé Diabète; 2022 (https://santediabete.org/wp-content/uploads/2022/05/ SD-MSF-Diabetes_NCDs_TechBrief_AC-SD_Diabetes-resolution_ENG_May2022.pdf, accessed 4 April 2023). 8. Diabetes supplies: are they there when needed? Seattle (WA): PATH; 2015 (https://www. ghtcoalition.org/resources/diabetes-supplies-are-they-there-when-needed.pdf, accessed 4 April 2023).