HBA1C Reduction with Digital Health Devices in Type 2 Diabetes (T2DM): A Meta-Analysis of Randomized Controlled Trials


Lee F1, Han-Burgess E2, Kennedy A1, Serafini P3, Pourrahmat MM3, Breznen B3
1Sanofi, Bridgewater, NJ, USA, 2Sanofi, Cambridge, MA, USA, 3Evidinno Outcomes Research Inc., Vancouver, BC, Canada

OBJECTIVES: To assess the efficacy of digital interventions in promoting HbA1c reduction relative to usual care in T2DM.

METHODS: A systematic literature review was conducted by searching MEDLINE®, Embase®, and CENTRAL databases on April 5, 2022 to identify studies which compared usual care to digital interventions consisting of (at minimum) a blood glucose measuring device and coaching from a healthcare professional. Random effects models were used for all meta-analyses.

RESULTS: Of 23 eligible trials, 20 measured HbA1c in a laboratory setting and formed the primary analysis set. Average participant age was 56.4 years with a BMI of 31.3 kg/m2 and an HbA1c of 8.4%. Intensity of the digital intervention arm was classified as high (n=5), medium (n=12), or low (n=3), based on frequency of contact and how personalized and comprehensive the coaching was. Two studies employed continuous glucose monitoring (CGM), and the Cochrane risk of bias tool identified four studies as high-risk because they were unblinded or used ambiguous/unreliable glucose measurement. The primary analysis estimated −0.31% greater HbA1c reduction with digital interventions compared to usual care (95%CI: −0.45, −0.16; p<0.0001). Meta-regression estimated significantly greater reduction relative to usual care for high intensity (−0.43, 95%CI: −0.74, −0.11; p = 0.0084) and medium intensity (−0.22, 95%CI: −0.38, −0.06; p = 0.0055) interventions, but not low intensity interventions (−0.25, 95%CI: −0.57, 0.07; p = 0.13). When studies which did not measure HbA1c in a laboratory were added to the primary set, the difference between digital interventions and usual care increased to −0.40% (95%CI: −0.56, −0.24; p < 0.0001). Excluding high-risk and CGM studies did not affect the primary analysis results.

CONCLUSIONS: Digital interventions are associated with greater HbA1c reduction in T2DM patients compared to usual care. A non-significant association between intensity and HbA1c reduction was observed, which warrants further investigation to understand optimal intensity for digital interventions.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA

Value in Health, Volume 26, Issue 6, S2 (June 2023)




Medical Technologies


SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)

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