Abstract
Background:
We present a digital therapeutic (DTx) using continuous glucose monitoring (CGM) and an advanced artificial intelligence (AI) algorithm to digitally personalize lifestyle interventions for people with type 2 diabetes (T2D).
Method:
A study of 118 participants with non–insulin-treated T2D (HbA
1c
≥ 6.5%) who were already receiving standard care and had a mean baseline (BL) HbA
1c
of 7.46% (0.93) used the DTx for three months to evaluate clinical endpoints, such as HbA
1c
, body weight, quality of life and app usage, for a pre-post comparison. The study also included an assessment of initial long-term data from a second use of the DTx.
Results:
After three months of using the DTx, there was an improvement of 0.67% HbA
1c
in the complete cohort and −1.08% HbA
1c
in patients with poorly controlled diabetes (BL-HbA
1c
≥ 7.0%) compared with standard of care (
P
1c
levels and a mean weight loss of −6.84 kg after six months (
P
Conclusions:
These results indicate that the DTx has clinically relevant effects on glycemic control and weight reduction for patients with both well and poorly controlled diabetes, whether through single or repeated usage. It is a noteworthy improvement in T2D management, offering a non-pharmacological, fully digital solution that integrates biofeedback through CGM and an advanced AI algorithm.