Type 2 diabetes reversal with digital twin technology-enabled precision nutrition and staging of reversal: a retrospective cohort study

Abstract

Background: Type 2 diabetes reversal has been viewed in the literature primarily as a dichotomous event (reversed or not reversed), even though this viewpoint may not be optimal for clinicians or patients. This cohort study's objectives were to define stages of type 2 diabetes reversal and measure changes in reversal stages before and after 90 days of digital twin-enabled precision nutrition therapy.

Methods: This study defines seven stages of diabetes reversal. The study is a retrospective pre/post comparison of changes in reversal stage, hemoglobin A1c (HbA1c), weight, body mass index (BMI), and other metrics measured before and after precision nutrition therapy. Reversal stages were defined as Stage 0: HbA1c < 5.7% without medication for > 1 year, Stage 1: HbA1c < 5.7% without medication for < 1 year, Stage 2: HbA1c < 6.5% without medication, Stage 3: estimated HbA1c (eA1c) between 5.7 and 6.4% without medication, Stage 4: estimated HbA1c (eA1c) between 5.7 and 6.4% with metformin monotherapy, Stage 5: dual oral therapy, Stage 6: > = 3 medications.

Results: Reversal stage information was available for 463 patients at baseline and 90 days. At baseline, the proportions of patients in each reversal stage were Stages 1 and 2: 0%, Stage 3: 1%, Stage 4: 8%, Stage 5: 6%, and Stage 6: 85%. After 90 days, the proportions in each reversal stage were Stage 1: 2%, Stage 2: 9%, Stage 3: 32%, Stage 4: 39%, Stage 5: 7%, and Stage 6: 11%, indicating significant progress. Reversal stage progression rates varied by patient subgroup.

Conclusions: Type 2 diabetes patients reached differing reversal stages during 90 days of precision nutrition therapy. Use of reversal stages may benefit patients during therapy.

Trial registration: This was a retrospective study that was approved by the Medisys Clinisearch Ethical Review Board (without registration number) in 2019.

Keywords: Artificial intelligence; Diabetes medication elimination; Diabetes reversal; Digital twin technology; Precision nutrition; Type 2 diabetes.

Fig. 1

Percent of 463 Patients in Stages of Diabetes Reversal at Baseline and 90 Days. HbA1c: glycated hemoglobin. eA1c: estimated glycated hemoglobin from continuous glucose monitoring

Fig. 2

Stages of Diabetes Reversal for 463 Patients at Baseline and at 90 Days by Type 2 Diabetes Cluster. Diabetes reversal stages: Stage 6: > = 3 antidiabetic medications; Stage 5: dual oral therapy; Stage 4: metformin monotherapy (< 2000 mg) with eA1c between 5.7 and 6.4%; Stage 3: no antidiabetic medication with eA1c between 5.7 and 6.4%; Stage 2: HbA1c < 6.5% without antidiabetic medication; Stage 1: HbA1c < 5.7% without antidiabetic medication for less than 1 year; Stage 0: HbA1c < 5.7% without antidiabetic medication for more than 1 year. MOD: mild obesity-related diabetes; MARD: mild age-related diabetes; SIRD: severe insulin-resistant diabetes; SIDD: severe insulin-dependent diabetes

Fig. 3

Days to Reversal Stage 3 for 463 Patients. Diabetes reversal Stage 3: no antidiabetic medication with eA1c between 5.7 and 6.4%. MOD: mild obesity-related diabetes; MARD: mild age-related diabetes; SIRD: severe insulin-resistant diabetes; SIDD: severe insulin-dependent diabetes