Self-measurement of blood glucose in patients with non-insulin treated diabetes mellitus type 2

Eichler K., Tzogiou C., Knöfler F., Slavik E., Monteverde S., Wieser S.
Record ID 32018000309
English
Original Title: Blutzuckerselbstmessung bei nicht insulin-pflichtigem Diabetes mellitus Typ 2
Authors' objectives: To assess the effect on HbA1c and cost-effectiveness of adding self-measurement of blood glucose (SMBG) to usual care in adult non-insulin treated T2DM compared to usual care without SMBG.
Authors' results and conclusions: Results: We retrieved 2,882 records and included 24 RCTs and 10 economic studies. Comparing several SMBG protocols of the intervention groups with no, less frequent or less structured SMBG leads to a statistically significant HbA1c decrease of -0.29%-points (95%CI: -0.40 to 0.18; 23 RCT; low certainty of evidence). Based on our model, this HbA1c decrease translates into small but statistically significant reductions in several diabetes-related complications. SMBG leads to a modelled increase in life expectancy of 18 days (95%-CI: 13 to 25) with increased total costs of CHF 2,910 (95%-CI: 2,750 to 3,021) over a time horizon of 40 years. Based on this small health benefit and on the low total additional costs, SMBG has a formal ICER of CHF 65,023 per QALY gained. In studies without any SMBG in the control group, the HbA1c decrease is more pronounced (-0.33%-points; 95%CI: -0.45 to -0.21; 17 RCT). SMBG is more cost-effective with the ICER decreasing to CHF 41,078 per QALY gained. SMBG was associated with a significantly increased probability of detecting hypoglycaemia (RR 2.10; 95%-CI: 1.41 to 3.15; 4 RCTs with high proportions of patients treated with sulfonylureas; episodes of mild and non-severe nature; moderate quality of evidence). SMBG increases the probability of «being in HbA1c target» (RR 2.78; 95%-CI: 1.46 to 5.31; 5 RCTs; low quality of evi-dence). No relevant differences were seen in the RCTs for psychological outcomes (e.g. depres-sive symptoms, quality of life, patient satisfaction with treatment [moderate to high certainty evi-dence]), morbidity, mortality, and unexpected events and harms [low certainty of evidence]). Only 1 in 4 non-insulin treated patients with T2DM in Switzerland bought SMBG test strips in 2017 and most of those buying test strips bought substantially less than the maximum amount reimbursed. A total elimination of test strip coverage for non-insulin treated T2DM patients would lead to net savings of CHF 6.09 million per year (budget impact) from a Swiss healthcare payers’ perspective. Organisational issues of relevance are proper documentation of SMBG results by patients (possi-bly supported by smartphone applications) and adequate handling of SMBG by vulnerable groups (e.g. elderly persons with visual dysfunction or limited motor skills). From a socio-legal perspec-tive, restricting the provision of blood glucose test strips to a certain group of patients must be based on objective reasons (WZW criteria on the basis of the HTA), but may under no circum-stances be unilaterally at the expense of vulnerable groups. From an ethical perspective, the evi-dence base to question current best practices appears to be scant: SMBG is associated with a slight improvement of HbA1c levels, but it is unclear to which extent this result is also clinically relevant. At a psychological level, SMBG allows a higher degree of participation of patients in the care process, but there is no clear evidence about improved psychological outcomes in the target population. Conclusions: SMBG shows modest efficacy on HbA1c levels in RCTs. Model calculations based on this finding suggest a resulting small increase in life expectancy. However, since this has so far not been evaluated in clinical studies, this outcome cannot be confirmed nor rebutted.
Authors' methods: We performed literature searches, quantitative and qualitative evidence synthesis. For our eco-nomic analysis we used a diabetes simulation modelling approach (UKPDS-OM2).
Details
Project Status: Completed
Year Published: 2019
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Switzerland
MeSH Terms
  • Diabetes Mellitus
  • Blood Glucose
  • Blood Glucose Self-Monitoring
  • Diabetes Mellitus, Type 2
  • Patient Reported Outcome Measures
  • Cost-Benefit Analysis
Keywords
  • diabetes mellitus
  • self-measurement
  • blood glucose
  • diabetes type 2
  • non-insulin treated
  • HbA1c
  • PROMs
  • costs
  • economics
  • effectiveness
  • safety
  • cost-effectiveness
  • efficacy
  • budget impact
  • legal
  • social
  • ethical
  • organisational
Contact
Organisation Name: Swiss Federal Office of Public Health (FOPH)
Contact Address: Federal Office of Public Health, Schwarzenburgstrasse 157, CH-3003 Berne, Switzerland
Contact Name: Klazien Matter-Walstra
Contact Email: hta@bag.admin.ch
Copyright: Swiss Federal Office of Public Health
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.