Continuous Care Intervention Research Articles

5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study

AimsThis study assessed the five-year effects of a continuous care intervention (CCI) delivered via telemedicine, counseling people with type 2 diabetes (T2D) on a very low carbohydrate diet with nutritional ketosis. MethodsParticipants with T2D were enrolled in a 2-year, open-label, non-randomized study comparing CCI and usual care (UC). After 2 years, 194 of the 262 CCI participants were approached for a three-year extension. Of these, 169 consented, and 122 remained in the study for five years. Primary outcomes were changes in diabetes status assessed using McNemars’ test, including remission and HbA1c < 6.5 % on no glucose lowering medication or only on metformin at 5 years. Changes in body mass, glycemia, and cardiometabolic markers from baseline to 5 years were assessed using linear mixed-effects models. ResultsTwenty percent (n = 24) of the five-year completers achieved remission, with sustained remission observed over three years in 15.8 % (n = 19) and four years in 12.5 % (n = 15). Reversal to HbA1c < 6.5 % without medication or only metformin was seen in 32.5 % (n = 39). Sustained improvements were noted in body mass (−7.6 %), HbA1c (−0.3 %), triglycerides (−18.4 %), HDL-C (+17.4 %), and inflammatory markers, with no significant changes in LDL-C and total cholesterol. ConclusionsOver five years, the very low carbohydrate intervention showed excellent retention and significant health benefits, including diabetes remission, weight loss, and improved cardiometabolic markers.

Personalized and continuous care intervention affects rehabilitation, living quality, and negative emotions of patients with breast cancer

BACKGROUND Breast cancer is among the most common malignancies worldwide. With progress in treatment methods and levels, the overall survival period has been prolonged, and the demand for quality care has increased. AIM To investigate the effect of individualized and continuous care intervention in patients with breast cancer. METHODS Two hundred patients with breast cancer who received systemic therapy at The First Affiliated Hospital of Hebei North University (January 2021 to July 2023) were retrospectively selected as research participants. Among them, 134 received routine care intervention (routing group) and 66 received personalized and continuous care (intervention group). Self-rating anxiety scale (SAS), self-rating depression scale (SDS), and Functional Assessment of Cancer Therapy-Breast (FACT-B) scores, including limb shoulder joint activity, complication rate, and care satisfaction, were compared between both groups after care. RESULTS SAS and SDS scores were lower in the intervention group than in the routing group at one and three months after care. The total FACT-B scores and five dimensions in the intervention group were higher than those in the routing group at three months of care. The range of motion of shoulder anteflexion, posterior extension, abduction, internal rotation, and external rotation in the intervention group was higher than that in the routing group one month after care. The incidence of postoperative complications was 18.18% lower in the intervention group than in the routing group (34.33%; P &lt;0.05). Satisfaction with care was 90.91% higher in the intervention group than in the routing group (78.36%; P &lt;0.05). CONCLUSION Personalized and continuous care can alleviate negative emotions in patients with breast cancer, quicken rehabilitation of limb function, decrease the incidence of complications, and improve living quality and care satisfaction.

Tokophobia—Extreme Fear of Pregnancy and Birth and Implications for Care: A Case Report

The extreme or pathological fear of pregnancy and childbirth, also known as tokophobia, was first described in the mid-to-late 1800s but then rarely discussed in the literature until the turn of the 21st century. However, information remains scarce. Therefore, the goals of this case study are to describe the clinical presentation and management options of extreme fear of pregnancy and/or birth. The patient in our study is from the United States. She presented with tokophobia at her first prenatal appointment, requesting a cesarean surgery immediately, but experienced discontinuous care throughout her pregnancy. She became frustrated by the need to repeat her desire for a cesarean surgery and eventually was verbally disruptive at her 38-week visit, crying and yelling at providers and staff. If this patient had received continuous care and earlier intervention and education, her pregnancy may have been a more positive experience. This case highlights the importance of establishing a standard of care for women with tokophobia and then adapting that standard to fit each woman’s individual needs.

Effect of WeChat-based continuous care intervention on the somatic function, depression, anxiety, social function and cognitive function for cancer patients: Meta-analysis of 18 RCTs.

This meta-analysis systematically reviewed and identified the effects of WeChat-based continuous care (WCC) interventions on various outcomes in cancer patients. Systematic review and meta-analysis. In this study, outcome measures included somatic function, anxiety, depression, social function, and cognitive function. The standardized mean differences and 95% CIs of pooled effect sizes were calculated using fixed- and random-effects models. NFail-safe and Begg's tests were performed to evaluate publication bias, and sensitivity analysis was performed to evaluate the robustness of the meta-analysis results. The meta-analysis included 18 RCTs of moderate quality. WCC interventions significantly improved somatic function, depression, anxiety, social function, and cognitive function in cancer patients. There was no significant publication bias, and the sensitivity analysis indicated robust results. WCC interventions improved depression, anxiety, social function, and cognitive function in cancer patients.

Continuous care intervention with carbohydrate restriction improves physical function of the knees among patients with type 2 diabetes: a non-randomized study

BackgroundIn a previous study, we assessed a novel, remotely monitored carbohydrate restricted diet regimen including nutritional ketosis in patients with type 2 diabetes and reported significant improvements in weight, glycemic control, abdominal fat and inflammation from baseline to 2 years. Knee outcome measures were collected as a secondary outcome in the trial. This study aims to assess the effect of this intervention on knee functional scores and to identify if changes in weight, central abdominal fat (CAF), glycemic status and high sensitivity C-reactive protein (hsCRP) were associated with its improvement.MethodsThis prospective analysis included continuous care intervention (CCI, n = 173) and usual care (UC, n = 69) trial participants with type 2 diabetes that reported knee pain at baseline. Knee outcome measures included the Knee injury and Osteoarthritis Outcome Score (KOOS) pain, symptoms, activities of daily living (ADL), sports and recreation function, and knee-related quality of life subscales, and total KOOS score were assessed from baseline to 2 years. Missing data at each time point were replaced with multiple imputation under the assumption of missing at random. To assess if the primary analysis of the knee scores changed under plausible missing not at random assumptions, sensitivity analysis was also performed using pattern mixture models. In CCI, we also assessed factors associated with the improvement of knee scores.ResultsIn the primary analysis, CCI participants demonstrated a statistically significant improvement in total KOOS and all KOOS individual subscale scores at 1 year and maintained through 2 years as opposed to UC patients who showed no significant changes from baseline to 2 years. The significant improvement in total KOOS and its individual subscale scores from baseline to 2 years remained relatively stable in CCI in the sensitivity analysis under different missing not at random scenarios confirming the robustness of the findings from the primary analysis. Approximately 46% of the CCI participants met the 10 points minimal clinically important change at 2 years. A reduction in CAF was associated with improvement in total KOOS and KOOS ADL, while a decrease in hsCRP was associated with improvement in KOOS symptoms scores.ConclusionA very low carbohydrate intervention including nutritional ketosis resulted in significant improvements in knee pain and function among patients with T2D. The improvements in knee function were likely secondary to a reduction in central adiposity and inflammation. Future research on the applicability of this intervention in radiographically confirmed OA patients is important.Trial registrationClinical trial registration: NCT02519309 (10/08/2015).

Depressive symptoms improve over 2 years of type 2 diabetes treatment via a digital continuous remote care intervention focused on carbohydrate restriction

Depressive symptoms are prevalent among people with type 2 diabetes (T2D) and, even at low severity levels, are associated with worse diabetes outcomes. Carbohydrate restriction is an effective treatment for T2D but its long-term impacts on depressive symptoms are unclear. In the current study we explored changes in depressive symptoms over 2 years among 262 primarily non-depressed T2D patients participating in a continuous remote care intervention emphasizing carbohydrate restriction. Subclinical depressive symptoms decreased over the first 10 weeks and reductions were maintained out to 2 years. Increased frequency of blood ketone levels indicative of adherence to low carbohydrate eating predicted decreases in depressive symptoms. Concerns have been raised with recommending restrictive diets due to potential negative impacts on quality-of-life factors such as mood; however, results of the current study support positive rather than negative long-term impacts of closely monitored carbohydrate restriction on depressive symptoms.

Effect of Continuous Quality Care on HAMA, HAMD Score and Quality of Life in Patients with Acute Myocardial Infarction

Objective: To analyze the impact of continuous quality care on HAMA, HAMD score, and quality of life in patients with acute myocardial infarction. Methods: The 100 patients with acute myocardial infarction admitted to our hospital from January 2020 to January 2021 were selected and divided into control and observation groups according to the random number table method, with 50 patients in each group. Patients in the control group were given routine care after discharge, and patients in the observation group received continuous quality care intervention to compare the changes in HAMA, HAMD and quality of life scores before and after care between the two groups. Results: Lower HAMA, HAMD scores and higher quality of life scores compared to care in the observation group, and the difference between groups before and after care was significant (P&lt;0.05). Conclusion: Continuous quality care can effectively reduce anxiety and depression in AMI patients and improve quality of life, which deserves clinical application.

The effect of continuous supportive care on birth pain, birth fear, midwifery care perception, oxytocin use, and delivery time during the intrapartum period: An experimental study.

Intrapartum professional midwifery support can improve the coping skills with the fear of childbirth and birth pain, increase the perception of the woman, and prevent negative experiences. However, there are relatively few studies supporting this postulation. To investigate the effects of supportive care given during labor on birth pain, birth fear, perception of midwifery care, oxytocin use, and delivery time. This is a quasi-experimental study. We collected the data between January and June 2019 in a province in Central Anatolia, Turkey. Primiparous 102 pregnant women were included in the study. However, we excluded five pregnant women from the intervention group and four pregnant women from the control group as emergency cesarean section developed. In total, 93 pregnant women, 46 in the continuous supportive care intervention group, and 47 in the usual intrapartum care control group were evaluated. The following tools were used to collect data: The Delivery Fear Scale, a Visual Analog Scale for perceived pain, the Scale of Women's Perception for Supportive Care Given During Labor, and labor outcomes information form. The participants in the intervention group receiving continuous intrapartum supportive care had less fear of birth and lower birth pain in the active and transitional stages of labor, their midwifery care perception increased, and the duration of labor was shorter (P < 0.05). However, there was no significant difference in oxytocin use between the two groups at 95% confidence interval (-0.265-0.091) (p > 0.05, Cohen's d = 0.2). Pregnant women who received continuous intrapartum supportive care had less fear of birth and reduced labor pain in active and transitional stages of labor. In addition, with the continuous supportive care provided, the perception of midwifery care of the pregnant women increased and the duration of labor decreased. Therefore, midwifery care support should be provided to women throughout their labor and delivery process.

Exploration of the Application of Continuous Care Intervention in the Treatment of Patients with Chloasma by Q1064 nm Laser

Exploration of the Application of Continuous Care Intervention in the Treatment of Patients with Chloasma by Q1064 nm Laser

Influence of Continuous Care Intervention on Wound Stomy and Improvement of ECSA Scale Score

Influence of Continuous Care Intervention on Wound Stomy and Improvement of ECSA Scale Score

Ketogenic Diets Potentially Reverse Type 2 Diabetes Via Continuous Remote Care Intervention: A Case Study in Central China

Abstract Objectives Type 2 diabetes (T2D) remains a major public health challenge worldwide. Ketogenic diets (KD) have been reported to be effective in managing T2D, yet it is unclear if KD-based T2D management is suitable for patients in the central region of China where high-carbohydrate diets prevail. Here, an overweight T2D patient from Zhengzhou (Henan province), were enrolled in a 12-week KD-based continuous remote care intervention program. Methods Our 12-week intervention program is consisted of remote nutritional education, online personal coaching, and continuous monitoring of major biomarkers, e.g., body weight, blood pressure, continuous flash glucose monitoring, beta-hydroxybutyrate (BHB). The participant was advised to achieve and sustain nutritional ketosis through carbohydrate restriction since the onset of the study, and was instructed to reduce or stop diabetes medications within targeted continuous glucose levels, and to adjust carbohydrate intake in case of hypoglycemia. Results In 12 weeks, the participant (male; 52 years old) achieved a weight loss of 7.4 kg (from 90.1 kg to 82.7 kg), with waist circumference reduced from 103 cm to 97 cm and body mass index (BMI) reduced from 29.42 kg/m2 to 26.50 kg/m2; his HbA1c level and fasting glucose was reduced from 6.2% and 6.78 mmol/L at baseline to 5.8% and 5.48 mM/L repectively, with his fasting insulin decreased from 13.41 mM/L at baseline to 8.40 μIU/mL, HOMA-IR from 4.04 to 2.03, and an ideal ambulatory glucose profile (AGP) (Time in Range (TIR) ≧ 99%). The participant was advised to discontinue all diabetes medications after 1 week. During the 4th week, hypoglycemic events were detected, and the participant was advised to adjust carbohydrate intake; no hypoglycemic events were observed afterwards. Biomarkers related to blood lipids, lipoproteins, liver, kidney, thyroid and inflammation remained normal after the intervention. Conclusions Our results suggest that a 12-week KD-based continuous remote care intervention program featuring continuous flash glucose monitoring, can be effective and safe with high-level adherence in reversing T2D in a Chinese patient from central China. Funding Sources P.L. was supported by the National Natural Science Foundation of China (U1904158, U1604178) and the National high-tech developmental zone fund.

Impact of a 2-year trial of nutritional ketosis on indices of cardiovascular disease risk in patients with type 2 diabetes

BackgroundWe have previously reported that in patients with type 2 diabetes (T2D) consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) resulted in improved body weight, glycemic control, and multiple risk factors for cardiovascular disease (CVD) with the exception of an increase in low density lipoprotein cholesterol (LDL-C). In the present study, we report the impact of this intervention on markers of risk for atherosclerotic cardiovascular disease (CVD), with a focus on lipoprotein subfraction particle concentrations as well as carotid-artery intima-media thickness (CIMT).MethodsAnalyses were performed in patients with T2D who completed 2 years of this study (CCI; n = 194; usual care (UC): n = 68). Lipoprotein subfraction particle concentrations were measured by ion mobility at baseline, 1, and 2 years and CIMT was measured at baseline and 2 years. Principal component analysis (PCA) was used to assess changes in independent clusters of lipoprotein particles.ResultsAt 2 years, CCI resulted in a 23% decrease of small LDL IIIb and a 29% increase of large LDL I with no change in total LDL particle concentration or ApoB. The change in proportion of smaller and larger LDL was reflected by reversal of the small LDL subclass phenotype B in a high proportion of CCI participants (48.1%) and a shift in the principal component (PC) representing the atherogenic lipoprotein phenotype characteristic of T2D from a major to a secondary component of the total variance. The increase in LDL-C in the CCI group was mainly attributed to larger cholesterol-enriched LDL particles. CIMT showed no change in either the CCI or UC group.ConclusionConsumption of a very low carbohydrate diet with nutritional ketosis for 2 years in patients with type 2 diabetes lowered levels of small LDL particles that are commonly increased in diabetic dyslipidemia and are a marker for heightened CVD risk. A corresponding increase in concentrations of larger LDL particles was responsible for higher levels of plasma LDL-C. The lack of increase in total LDL particles, ApoB, and in progression of CIMT, provide supporting evidence that this dietary intervention did not adversely affect risk of CVD.

65-LB: Regression of Prediabetes following Two Years Treatment with a Continuous Care Intervention Emphasizing Carbohydrate Restriction: A Single-Arm, Prospective, Longitudinal Study

Regression from prediabetes (preD) to normoglycemia (NG) is associated with reduced progression to type 2 diabetes (T2D). Carbohydrate restriction including nutritional ketosis (CR) has emerged as a safe, effective, and sustainable treatment for regression of hyperglycemia in T2D, yet its multi-year effects on preD are unknown. Also, some patients have difficulty initiating and/or sustaining provider-recommended lifestyle changes. Thus, we hypothesized that a remotely delivered continuous care intervention (CCI) emphasizing CR would improve glycemia and weight in patients with preD. In a single-arm, prospective, longitudinal study, we assessed incidence of regression from preD to NG, progression from preD to T2D, and prevalence of metabolic syndrome (MetS) and class II or greater obesity in participants following two years of treatment. Patients with a preD diagnosis enrolled in the study (n=116). Outcomes were assessed among 96 participants (age: 52±10 y; BMI: 39.2±7.1 kg/m2) with preD defined as HbA1c&amp;lt;6.5% with metformin use or HbA1c 5.7-6.4% (inclusive) without glycemic control medication. Retention at two years was 75% (72/96). The crude incidence for first occurrence of regression from preD to NG (HbA1c &amp;lt;5.7% without medication) was 47.6 cases per 100 person-years. Estimated cumulative incidence of NG at two years was 52.3%. One new case of T2D each year was observed, and crude incidence of T2D diagnosis was 1.5 cases per 100 person-years. Estimated cumulative incidence of T2D at two years was 3%. Prevalence of MetS was reduced from 94% to 30% at one and 47% at two years (both P&amp;lt;4.4x10-16). Prevalence of class II or greater obesity was reduced from 67% to 38% at one and 39% at two years (both P&amp;lt;.0013). Among two-year completers, 62.5% achieved ≥7% weight loss. Given these observations, this study demonstrates the potential utility of a CCI emphasizing CR for treatment of preD. Disclosure A. McKenzie: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. S.J. Athinarayanan: Employee; Self; Virta Health Corp. J. McCue: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. R.N. Adams: Employee; Self; Virta Health Corp. J.P. McCarter: Employee; Self; Abbott Laboratories. Stock/Shareholder; Self; Virta Health. J. Volek: Advisory Panel; Self; Atkins Nutritionals, Cook Keto, Virta Health Corp. Stock/Shareholder; Self; PangeaKeto, Virta Health Corp. Other Relationship; Self; Beyond Obesity. Funding Virta Health Corp

725-P: Effect of a Continuous Remote Care Intervention on Glycemic Target Achievement and Medication Use among Adults with T2D: A Post Hoc Analysis

Background: Only about half of patients with type 2 diabetes (T2D) achieve the HbA1c &amp;lt;7% target, and maintenance often requires medication intensification over time. A continuous remote care intervention (CCI) including ketosis via carbohydrate restriction nutrition therapy was previously demonstrated to improve glycemic outcomes in adults with T2D for at least two years; here, we assess the proportion of patients meeting glycemic targets and accompanying medication use. Methods: Adults with T2D selected to receive the CCI (n=262) or usual care (UC; n=87). We utilized GEE to assess change in the proportion of patients at HbA1c &amp;lt;7% target and accompanying medication use at 1 and 2 years compared to baseline. Analyses were conducted among completers and on an intent-to-treat basis with missing data considered as missing the HbA1c target. Results: The proportion of CCI patients meeting the HbA1c &amp;lt;7% target significantly increased at 1 and 2 years (Table 1). A similar improvement trend was seen among those treated with a single drug (monotherapy), and the proportion of patients at target without the use of medication approximately tripled. No changes occurred among patients who selected UC. Conclusion: This suggests the CCI is an effective means to help more patients achieve the HbA1c &amp;lt;7% target, including with monotherapy or no medication, among those who choose it. Disclosure S.J. Athinarayanan: Employee; Self; Virta Health Corp. R.N. Adams: Employee; Self; Virta Health Corp. S. Hallberg: Advisory Panel; Self; Atkins Nutritionals, Inc. Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. S. Phinney: Advisory Panel; Self; Atkins Nutritionals, Inc. Stock/Shareholder; Self; Beyond Obesity LLC (publishing), Virta Health Corp. A. McKenzie: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp.

709-P: Long-Term Adherence to Carbohydrate Restriction Confers Added Benefits for Adults with T2D

Background: We previously observed that adherence to carbohydrate restriction (CR) nutrition therapy during the first 3 months of a continuous remote care intervention predicted 1-yr improvements in weight and HbA1c in adults with T2D. However, the extent to which ongoing CR is needed to sustain health improvements is unknown. Methods: 262 adults with T2D counseled on CR reported adherence measured by blood beta-hydroxybutyrate (BHB) regularly via a mobile app. Patients enrolled 1-yr with mean BHB ≥0.3 mM in the first 3 months (n=174) were split into quartiles based on the percent of BHB logs ≥ 0.3 and 0.5 mM during months 4 through 12. We conducted ANOVAs to compare the groups’ percent change in weight and HbA1c from baseline to 1-yr. Results: All groups had clinically significant improvements on average in weight and HbA1c, but the percent change statistically differed by group (Ps&amp;lt;0.01). Participants who reported CR more often had greater benefit at 1-yr (Table 1). Using a 0.3 mM BHB cut-off, very consistent restriction (≥95% of the time) yielded significantly greater benefit. A 0.5 mM cut-off demonstrated greater benefit with lower frequencies of reporting (≥38% for weight and ≥66% for HbA1c). Discussion: More frequent CR over the remainder of the year conferred greater benefit on health outcomes. Future analyses should carefully examine whether the pattern of BHB values over time influences outcomes. Disclosure R.N. Adams: Employee; Self; Virta Health Corp. S.J. Athinarayanan: Employee; Self; Virta Health Corp. S. Phinney: Advisory Panel; Self; Atkins Nutritionals, Inc. Stock/Shareholder; Self; Beyond Obesity LLC (publishing), Virta Health Corp. A. McKenzie: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp.

SAT-LB125 Broad Spectrum Effects of a Ketogenic Diet Delivered by Remote Continuous Care on Inflammation and Immune Modulators in Type 2 Diabetes and Prediabetes

Type 2 diabetes (T2D) is associated with, and often preceded by, increased levels of circulating c-reactive protein (CRP) and WBC count that mediate the body’s inflammatory and immune responses (inflammatory mediators [IMs]). This relationship between inflammation and diabetes is complex, as statins have anti-inflammatory properties but paradoxically promote or exacerbate T2D. Recently it has been reported that beta-hydroxybutyrate levels characteristic of nutritional ketosis enhance cellular defenses against oxidative stress and block the assembly of the NLRP3 inflammasome. As part of an ongoing study of the effects of a well-formulated ketogenic diet (WFKD) delivered via a web-based continuous care intervention (CCI) on 262 patients with T2D1 and 116 with prediabetes (PreD), we determined plasma levels of 16 IMs at baseline, 1 yr, and 2 yrs. These same IMs were concurrently monitored in 87 patients with T2D recruited as usual care controls (UC). At baseline, a statin was prescribed for 50% of the T2D/CCI patients, 27% of PreD/CCI patients, and 59% of the T2D/UC patients; at which time statin use was associated with reduced plasma CRP (P=7 x 10-5) compared to non-statin users in the T2D/CCI group only. There were no other significant baseline differences between statin users and non-users for any IMs (WBC, TNFa, IL-1b, IL-6, IL-8, IL-18, IFN-g, E- L-, and P-selectins, EGF, VEGF-A, MCP-1, ICAM-1 and VCAM-1). After 1 yr and 2 yrs of the CCI, mean weight losses in T2D were 12% and 10%, HbA1c reductions were 1.3% and 0.9%, and diabetes medication use was reduced by 51% and 53%, respectively. Linear mixed effects models were used to assess change in IMs over the 2 yrs, facilitating intent-to-treat analyses. Fourteen of the 16 IMs (excluding ICAM-1 and VCAM-1) were reduced compared to baseline in T2D/CCI (P<0.001), with none showing significant increases between yrs 1 and 2. A similar pattern albeit at lower magnitudes was seen in patients with PreD/CCI. Despite lower CRP values at baseline, T2D/CCI patients prescribed a statin experienced further reductions with the WFKD over the 2 years (P=3 x 10-5). In the T2D/UC group, no significant changes in any of the IMs were observed at 1 yr or 2 yrs. These observations suggest that a WFKD delivered via the CCI has broad-spectrum anti-inflammatory and immune modulatory effects in patients with T2D and PreD. Consistent with prior reports, statin use was associated with reduced CRP at baseline in the T2D/CCI group, but this effect was not significant in PreD/CCI and T2D/UC groups. CRP reductions were nonetheless significant in T2D/CCI statin users, suggesting added benefit of the WFKD. We conclude that improvements in IMs induced by a combination of nutritional ketosis and weight loss contribute to the beneficial effects of the CCI in the management of T2D.1. Athinarayanan SJ, et al. Front Endocrinol. 2019. 5;10:348

SUN-LB113 A Continuous Remote Care Intervention Utilizing Carbohydrate Restriction Including Nutritional Ketosis Improves Markers of Metabolic Risk and Reduces Diabetes Medication Use in Patients With Type 2 Diabetes Over 3.5 Years

Novel lifestyle, pharmaceutical, and/or surgical therapies for type 2 diabetes (T2D) are under study to assess lasting impact on metabolic risk. Among them, carbohydrate restriction including nutritional ketosis (CR) has emerged as a safe and effective nutrition therapy for reducing hyperglycemia in patients with T2D1, yet longer term effects are unknown. At the conclusion of a 2-year study assessing a continuous remote care intervention utilizing CR (CCI) among patients who selected this therapy, intervention participants were offered the opportunity to consent to participate in a 3-year extension assessing outcomes at 3.5- and 5-y following initial enrollment. 143 of 169 extension-consented participants provided data at 3.5-y follow up. Among 3.5-y completers, linear mixed effects models were used to assess change over time in diabetes-related outcomes and McNemar’s tests were used to assess for a difference in the proportion of participants meeting certain criteria at baseline compared to follow-up. At enrollment, 3.5-y completers were (mean±SE) 55±1 y of age, 40.8±0.7 kg/m2, and 8±1 y since diagnosis. Following treatment with the CCI for 3.5 y, significant improvements compared to baseline were observed in HbA1c (-0.6±0.1 from 7.4±0.1%; P = 1.9x10-5), weight (-10.9±1.1 from 117.4 kg; P = 6.9x10-17), nonHDL-C (-10±4 from 139±3 mg/dL; P = 0.005), triglycerides (-41±11 from 189±10 mg/dl; P = 2.1x10-4), and HDL-C (+9±1 from 43±1 mg/dl; P = 3.0x10-11); total cholesterol and LDL-C were statistically unchanged. The percentage of participants prescribed diabetes medication decreased from 84.6 to 67.1% (P = 5.0x10-6), while 50.2% of diabetes medications and 71.4% of diabetes medications other than metformin were discontinued. The percentage of participants treated with no pharmaceuticals or monotherapy increased from 52.5 to 81.9% (P = 1.3x10-8). 45.5% (65/143) of participants achieved HbA1c <6.5% with either no medication (34/65, 52%) or only metformin (31/65, 48%) at 3.5 y; 37.8% of participants maintained this status from 1 through 3.5 y of treatment. 22% of participants achieved diabetes remission at 3.5 y, and 17.5% of participants maintained remission status from 2 through 3.5 y of treatment. This demonstrates that clinically meaningful improvements across multiple markers of metabolic risk can be sustained in patients with T2D who selected treatment with this CCI for 3.5 y. Improvements in metabolic risk markers reduced the need for diabetes medication, allowing some patients to achieve and sustain diabetes remission. This ongoing trial will assess 5-y effects.1. American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care. 2020; 43(Supplement 1): S48-S65. 2. Athinarayanan SJ, et al. Front Endocrinol. 2019; 10:348.

Effect of continuous nursing interventions on valve noise-related anxiety and quality of life in patients who underwent mechanical mitral valve replacement

ObjectiveThe purpose of this study was to evaluate the effect of continuous nursing interventions on valve noise-related anxiety in patients undergoing mechanical mitral valve replacement (MVR) and to analyze its impact on patient quality of life.MethodsNinety patients who underwent mechanical MVR were divided into two groups. All patients in group A received routine nursing care. In addition to this intervention, an assigned nurse periodically provided patients in group B with continuous nursing interventions and ongoing health consultations during a 1-year follow-up. A hospital anxiety and depression (HAD) scale, a customized questionnaire and a Short Form Health Status 36 (SF-36) score questionnaire were used as the research tools.ResultsThe postoperative HAD scores were better in group B than in group A, but the differences in most of the data were not statistically significant between the groups, except for HA sections 0–7 and 11–21. Based on the customized questionnaire, the subjective disturbance level was significantly lower in group B than in group A (the results of Q1 and Q4 were statistically significant). With regard to the SF-36 scores, group B was superior to group A in general health, emotional function and mental health, while the other dimensions had no significant difference.ConclusionsCompared with routine care, patients who received continuous care intervention after mechanical MVR had fewer anxiety symptoms and better quality of life.

Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial.

Purpose: Studies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. We previously reported the effectiveness of a novel digitally-monitored continuous care intervention (CCI) including nutritional ketosis in improving weight, glycemic outcomes, lipid, and liver marker changes at 1 year. Here, we assess the effects of the CCI at 2 years.Materials and methods: An open label, non-randomized, controlled study with 262 and 87 participants with T2D were enrolled in the CCI and usual care (UC) groups, respectively. Primary outcomes were retention, glycemic control, and weight changes at 2 years. Secondary outcomes included changes in body composition, liver, cardiovascular, kidney, thyroid and inflammatory markers, diabetes medication use and disease status.Results: Reductions from baseline to 2 years in the CCI group resulting from intent-to-treat analyses included: HbA1c, fasting glucose, fasting insulin, weight, systolic blood pressure, diastolic blood pressure, triglycerides, and liver alanine transaminase, and HDL-C increased. Spine bone mineral density in the CCI group was unchanged. Use of any glycemic control medication (excluding metformin) among CCI participants declined (from 55.7 to 26.8%) including insulin (-62%) and sulfonylureas (-100%). The UC group had no changes in these parameters (except uric acid and anion gap) or diabetes medication use. There was also resolution of diabetes (reversal, 53.5%; remission, 17.6%) in the CCI group but not in UC. All the reported improvements had p < 0.00012.Conclusion: The CCI group sustained long-term beneficial effects on multiple clinical markers of diabetes and cardiometabolic health at 2 years while utilizing less medication. The intervention was also effective in the resolution of diabetes and visceral obesity with no adverse effect on bone health.Clinical Trial Registration: Clinicaltrials.gov NCT02519309

760-P: Factors Associated with Resolution of Steatosis and Fibrosis in T2D Patients Following Two Years of Continuous Care Intervention

Introduction: Nonalcoholic fatty liver disease (NAFLD) is associated with type 2 diabetes (T2D) progression. Our 2-year study of T2D patients demonstrated a continuous care intervention (CCI) including nutritional ketosis improved non-invasive scores of steatosis and fibrosis, in addition to weight and glycemic control. This post hoc analysis assesses factors affecting steatosis and fibrosis resolution. Methods: 262 T2D CCI patients were analyzed. Intent-to-treat correlation and ANCOVA assessed relationships between changes in selected variables (Table 1) and changes in NAFLD liver fat (NLF) and NAFLD fibrosis (NFS) scores, steatosis and fibrosis status. Results: Changes in HOMA-IR, central abdominal fat (CAF) and beta-hydroxybutyrate (BHB) were correlated with changes in NLF, while changes in HbA1c, CAF and HDL-cholesterol were correlated with changes in NFS, even after adjustment for age, gender, race, diabetes duration and baseline BMI. ANCOVA confirmed that patients who resolved steatosis had greater BHB increase (p=0.01), HOMA-IR reduction (p=1.3x10-5) and CAF reduction (p=0.01) than those who did not. Conclusions: Following the CCI, increased BHB and decreased insulin resistance are associated with steatosis resolution, while decreased visceral obesity is associated with steatosis and fibrosis reduction. Disclosure S.J. Athinarayanan: Employee; Self; Virta Health Corp. R.N. Adams: Employee; Self; Virta Health Corp. A. McKenzie: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. S. Hallberg: Advisory Panel; Self; Atkins Nutritionals, Inc. Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. S. Phinney: Advisory Panel; Self; Atkins Nutritionals, Inc. Board Member; Self; Virta Health Corp. Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. Other Relationship; Self; Beyond Obesity. J.P. McCarter: Employee; Self; Virta Health Corp. Funding Virta Health Corp