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

Paramesh Shamanna, Shashank Joshi, Lisa Shah, Mala Dharmalingam, Banshi Saboo, Jahangir Mohammed, Maluk Mohamed, Terrence Poon, Nathan Kleinman, Mohamed Thajudeen, Ashok Keshavamurthy
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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.

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利用数字孪生技术实现 2 型糖尿病逆转的精准营养和逆转分期:一项回顾性队列研究。
背景:2型糖尿病逆转在文献中主要被视为二分法事件(逆转或未逆转),尽管这种观点对临床医生或患者来说可能并不理想。这项队列研究的目的是定义2型糖尿病的逆转阶段,并测量数字孪生精准营养疗法90天前后逆转阶段的变化:本研究定义了糖尿病逆转的七个阶段。该研究是一项回顾性的前后对比研究,比较了精准营养疗法前后逆转阶段、血红蛋白 A1c (HbA1c)、体重、体重指数 (BMI) 和其他指标的变化。逆转阶段定义为 0 阶段:HbA1c 1 年,1 阶段:HbA1c = 3 种药物:结果:463 名患者在基线和 90 天内均可获得逆转阶段信息。基线时,处于各逆转阶段的患者比例分别为:第 1 和第 2 阶段:0%;第 3 阶段:1%;第 4 阶段:8%;第 5 阶段:6%;第 6 阶段:85%。90 天后,各逆转阶段的比例分别为:第 1 阶段:2%;第 2 阶段:9%;第 3 阶段:32%;第 4 阶段:39%;第 5 阶段:7%;第 6 阶段:11%,表明病情有了显著进展。不同亚组患者的逆转阶段进展率各不相同:结论:2 型糖尿病患者在接受精准营养治疗的 90 天内达到了不同的逆转阶段。使用逆转阶段可使患者在治疗过程中获益:这是一项回顾性研究,于2019年获得Medisys Clinisearch伦理审查委员会批准(无注册号)。
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审稿时长
8 weeks
期刊介绍: Clinical Diabetes and Endocrinology is an open access journal publishing within the field of diabetes and endocrine disease. The journal aims to provide a widely available resource for people working within the field of diabetes and endocrinology, in order to improve the care of people affected by these conditions. The audience includes, but is not limited to, physicians, researchers, nurses, nutritionists, pharmacists, podiatrists, psychologists, epidemiologists, exercise physiologists and health care researchers. Research articles include patient-based research (clinical trials, clinical studies, and others), translational research (translation of basic science to clinical practice, translation of clinical practice to policy and others), as well as epidemiology and health care research. Clinical articles include case reports, case seminars, consensus statements, clinical practice guidelines and evidence-based medicine. Only articles considered to contribute new knowledge to the field will be considered for publication.
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