Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation.

BACKGROUND: Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes. OBJECTIVE: This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program. METHODS: We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient's CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants' hemoglobin A1c (HbA1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes. RESULTS: At the end of the 90 days of the program, the mean HbA1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m2 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m2 in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times. CONCLUSIONS: Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM.

Gluco-friendly rice consumption: Balancing the palate with the pancreas.

Rice, or Oryza sativa/ Oryza glaberrima is the largest sources of carbohydrates, and calories, for mankind. It is the staple food across many countries of America, Africa and Asia. Hence, we need gluco-friendly ways of incorporating rice-based menus into the cuisine of persons living with diabetes. This multinational article discusses this challenge, and highlights the importance of informed and shared decision making with persons living with diabetes.

Personalized glycemic response led digital therapeutics program improves time in range in a period of 14 days.

Background: Lifestyle modification is an integral aspect for the management of type 2 diabetes (T2D). However, it is difficult to ensure the accuracy of personalized lifestyle advice. The study aims to analyse the real-world effectiveness of personalized glycemic response based Diabefly-Pro digital therapeutics for better glycemic control. Methods: Data from continuous glucose monitoring (CGM) of 64 participants with T2D was analysed. All participants were provided with modified lifestyle plan based on their personalized glycemic response. The CGM data was analysed for a period of 7 days, before and after the introduction of modified lifestyle plan. Primary outcome of the study was change in time in range (TIR). Secondary outcomes of the study were change in mean blood glucose, time above range (TAR), time below range (TBR) and glucose management indicator (GMI). Results: Significant improvement in glycemic control was observed after the introduction of personalized lifestyle plan. Median reduction in mean blood glucose was from 139.5 (118.3 to 169.3) mg/dL to 122.0 (101.5 to 148.8) mg/dL (p < 0.0001). TIR and GMI improved from 70.50 (50.75 to 83.50) % to 75.00 (58.25 to 89.00) % (p = 0.0001) and 6.64 (6.13 to 7.35) % to 6.23 (5.74 to 6.86) % (p < 0.0001) respectively. TAR reduced significantly from 17.00 (4.25 to 38.0) % to 6.00 (1.25 to 26.0) % (p < 0.0001). No significant increase in TBR was observed (p = 0.198). Conclusion: Personalized glycemic response-based Diabefly-Pro digital therapeutics program was effective in achieving better glycemic control in people with T2D.

"Show me the way" - Endoilluminator-assisted manual small-incision cataract surgery in a case of corneal scar with a small pupil.

Cataracts with coexisting corneal opacities due to various causes present a daunting challenge to surgeons. Adding to the plight could be factors like shallow anterior chamber, small pupil and mono-ocular patient. A manual small-incision cataract surgery (MSICS) could be a saviour in such situations. We demonstrate a case of post perforation corneal scar secondary to Hansen's disease with complicated cataract with non-dilating pupil in a bilaterally blind patient. Due to poor visualisation, there could have been difficulties in capsulorrhexsis, cortex aspiration & many other intraoperative manoeuvres, but use of an endo illuminator providing oblique illumination was very useful, resulting in uneventful surgery with good visual outcome. MSCICS, a surgery with minimal instrumentation, short learning curve and comparable results to phacoemulsification is perhaps the preferred procedure, in India, for complicated cataracts with multiple pre-existing pathologies.

Type 2 Diabetes in Women: Differences and Difficulties.

BACKGROUND: Lifestyle modification, along with medication, has improved the quality of life of patients with type 2 diabetes (T2D), but the treatment of diabetes in women still lacks a gender-centric approach. METHODS: Expert opinions to improve diabetes management in women were collated from the open discussion forum organized by the sixth Jothydev's Professional Education Forum Diabetes Convention, which included global diabetes care experts and the general public. The review is also based on the studies published in electronic databases such as PubMed and Google Scholar that discussed the problems and challenges faced by the Indian diabetes care sector in treating women with diabetes. RESULTS: The complex interplay of biological, socioeconomic, psychosocial, and physiological factors in women with type 2 diabetes has not been well addressed to date. Biological factors such as neurohumoral pathways, sex hormones, genetic predisposition as well as gender-based environmental and behavioural differences must be considered for modern personalized diabetes treatment. Most importantly, pregnant women with diabetes deserve special attention. This vulnerable phase has a marked impact on the future health of both the mother and the offspring. CONCLUSION: The review provides an overview of the challenges and issues that exist in the clinical management of diabetes and its complications among women in India. Women-centric clinical approaches should be encouraged for the effective management of diabetes in Indian women.

Culinary happiness.

Nutritional and dietary advice is the foundation of diabetes management. Unfortunately, such advice is seen in terms of intrusion and restriction of lifestyle, rather than as a health promoting intervention. This can be corrected by incorporating happiness into dietary modification. Culinary happiness can be defined as the process of sharing dietary, nutritional, and cooking advice, while ensuring the happiness associated with eating remains intact. The concept of culinary happiness includes all domains of culinary science: the procurement, preparation, plating and preservation of food.

Introduction of direct observation of procedural skills (DOPS) as a formative assessment tool during postgraduate training in anaesthesiology: Exploration of perceptions.

BACKGROUND AND AIMS: Formative assessment of procedural skills of Anaesthesiology postgraduate (PG) students is not conducted conventionally. Direct observation of procedural skills (DOPS) helps to identify gaps in performance and provides structured feedback. The present study was taken to explore perceptions of PG students and faculty about DOPS. METHODS: This mixed design interventional study was conducted on 12 PGs and 10 faculty members in Department of Anaesthesiology. After conducting DOPS, a pre-validated questionnaire was given to them about perceptions using 3-point Likert's scale along with open ended questions. Statistical analysis was done using descriptive statistics of perception to calculate percentages and themes were identified for qualitative data. RESULTS: Responses of students were positive about skill improvement (83%), time provided (75%), feedback (100%), interaction (83%), motivation (83%), satisfaction (83%), effectiveness (83%) and opportunity creation (92%). Faculty responded positively regarding change in attitude (100%), effectiveness (100%), scope (90%), feasible application (90%), ease (90%), opportunity creation (80%), gap identification (100%), satisfaction (80%). However, 60% felt training was required, 50% thought more time and commitment was required. Themes identified were DOPS is comprehensive, interactive, student-friendly, good teaching-learning tool, identifies gaps, provides focus for learning, provides systematic constructive feedback, improves skills, prepares for future practice, requires planning, may not reflect competence, has assessor variability and can be included in PG curriculum. CONCLUSION: DOPS was perceived as an effective assessment and teaching-learning tool by PG students as well as faculty.

Evaluating Glycemic Control in Patients of South Asian Origin With Type 2 Diabetes Using a Digital Therapeutic Platform: Analysis of Real-World Data.

BACKGROUND: Digital therapeutics are evidence-based therapeutic interventions driven by high-quality software programs for the treatment, prevention, or management of a medical disorder or disease. Many studies in the western population have shown the effectiveness of mobile app-based digital therapeutics for improving glycemic control in patients with type 2 diabetes (T2D). However, few studies have assessed similar outcomes in the South Asian population. OBJECTIVE: This study aims to investigate the real-world effectiveness of the Wellthy CARE digital therapeutic for improving glycemic control among the South Asian population of Indian origin. METHODS: We analyzed deidentified data from 102 patients with T2D from India enrolled in a 16-week structured self-management program delivered using the Wellthy CARE mobile app. Patients recorded their meals, weight, physical activity, and blood sugar in the app, and they received lessons on self-care behaviors (healthy eating, being active, monitoring, medication adherence, problem solving, healthy coping, and reducing risks); feedback provided by an artificial intelligence-powered chatbot; and periodic interactions with certified diabetes educators via voice calls and chats. The primary outcome of the program was a change in glycated hemoglobin A1c (HbA1c). Secondary outcomes included the difference between preintervention and postintervention fasting blood glucose (FBG) and postprandial blood glucose (PPBG) levels; changes in BMI and weight at the completion of 16 weeks; and the association between program engagement and the changes in HbA1c, FBG, and PPBG levels. RESULTS: At the end of 16 weeks, the average change in HbA1c was -0.49% (n=102; 95% CI -0.73 to 0.25; P<.001). Of all the patients, 63.7% (65/102) had improved HbA1c levels, with a mean change of -1.16% (n=65; 95% CI -1.40 to -0.92; P<.001). The mean preintervention and postintervention FBG levels were 145 mg/dL (n=51; 95% CI 135-155) and 134 mg/dL (n=51; 95% CI 122-146; P=.02) and PPBG levels were 188 mg/dL (n=51; 95% CI 172-203) and 166 mg/dL (n=51; 95% CI 153-180; P=.03), respectively. The mean changes in BMI and weight were -0.47 kg/m2 (n=59; 95% CI -0.22 to -0.71; P<.001) and -1.32 kg (n=59; 95% CI -0.63 to -2.01; P<.001), respectively. There was a stepwise decrease in HbA1c, FBG, and PPBG levels as the program engagement increased. Patients in the highest tertile of program engagement had a significantly higher reduction in HbA1c (-0.84% vs -0.06%; P=.02), FBG (-21.4 mg/dL vs -0.18 mg/dL; P=.02), and PPBG levels (-22.03 mg/dL vs 2.35 mg/dL; P=.002) than those in the lowest tertile. CONCLUSIONS: The use of the Wellthy CARE digital therapeutic for patients with T2D showed a significant reduction in the levels of HbA1c, FBG, and PPBG after 16 weeks. A higher level of participation showed improved glycemic control, suggesting the potential of the Wellthy CARE platform for better management of the disease.

Oral Immunotherapy and Basophil and Mast Cell Reactivity in Food Allergy.

Basophil activation tests (BATs) can closely monitor, in vitro, a patient's propensity to develop type I hypersensitivity reactions. Because of their high specificity and sensitivity, BATs have become promising diagnostic tools, especially in cases with equivocal clinical histories, skin prick test results, and/or levels of specific IgE to allergen extracts. BATs also are useful as tools for monitoring the effects of treatment, since oral immunotherapy (OIT) studies report a diminution in patients' basophil responsiveness over the course of OIT. This review will discuss the BAT findings obtained before, during, and after OIT for food allergy. We will mainly focus on the association of basophil responsiveness, and alterations in basophil surface markers, with clinical outcomes and other clinical features, such as blood levels of specific IgG and IgE antibodies. The detailed analysis of these correlations will ultimately facilitate the use of BATs, along with other blood biomarkers, to differentiate short-term desensitization versus sustained unresponsiveness and to improve treatment protocols. Given the critical anatomic location of mast cells adjacent to the many IgE+ plasma cells found in the gastrointestinal tissues of allergic individuals, we will also discuss the role of gastrointestinal mast cells in manifestations of food allergies.

Origins and clonal convergence of gastrointestinal IgE+ B cells in human peanut allergy.

B cells in human food allergy have been studied predominantly in the blood. Little is known about IgE+ B cells or plasma cells in tissues exposed to dietary antigens. We characterized IgE+ clones in blood, stomach, duodenum, and esophagus of 19 peanut-allergic patients, using high-throughput DNA sequencing. IgE+ cells in allergic patients are enriched in stomach and duodenum, and have a plasma cell phenotype. Clonally related IgE+ and non-IgE-expressing cell frequencies in tissues suggest local isotype switching, including transitions between IgA and IgE isotypes. Highly similar antibody sequences specific for peanut allergen Ara h 2 are shared between patients, indicating that common immunoglobulin genetic rearrangements may contribute to pathogenesis. These data define the gastrointestinal tract as a reservoir of IgE+ B lineage cells in food allergy.

Aberrant B cell repertoire selection associated with HIV neutralizing antibody breadth.

A goal of HIV vaccine development is to elicit antibodies with neutralizing breadth. Broadly neutralizing antibodies (bNAbs) to HIV often have unusual sequences with long heavy-chain complementarity-determining region loops, high somatic mutation rates and polyreactivity. A subset of HIV-infected individuals develops such antibodies, but it is unclear whether this reflects systematic differences in their antibody repertoires or is a consequence of rare stochastic events involving individual clones. We sequenced antibody heavy-chain repertoires in a large cohort of HIV-infected individuals with bNAb responses or no neutralization breadth and uninfected controls, identifying consistent features of bNAb repertoires, encompassing thousands of B cell clones per individual, with correlated T cell phenotypes. These repertoire features were not observed during chronic cytomegalovirus infection in an independent cohort. Our data indicate that the development of numerous B cell lineages with antibody features associated with autoreactivity may be a key aspect in the development of HIV neutralizing antibody breadth.

Mathematical morphology for microaneurysm detection in fundus images.

AIM: Fundus image analysis is the basis for the better understanding of retinal diseases which are found due to diabetes. Detection of earlier markers such as microaneurysms that appear in fundus images combined with treatment proves beneficial to prevent further complications of diabetic retinopathy with an increased risk of sight loss. METHODS: The proposed algorithm consists of three modules: (1) image enhancement through morphological processing; (2) the extraction and removal of red structures, such as blood vessels preceded by detection and removal of bright artefacts; (3) finally, the true microaneurysm candidate selection among other structures based on feature extraction set. RESULTS: The proposed strategy is successfully evaluated on two publicly available databases containing both normal and pathological images. The sensitivity of 89.22%, specificity of 91% and accuracy of 92% achieved for the detection of microaneurysms for Diaretdb1 database images. The algorithm evaluation for microaneurysm detection has a sensitivity of 83% and specificity 82% for e-ophtha database. CONCLUSION: In automated detection system, the successful detection of the number of microaneurysms correlates with the stages of the retinal diseases and its early diagnosis. The results for true microaneurysm detection indicates it as a useful tool for screening colour fundus images, which proves time saving for counting of microaneurysms to follow Diabetic Retinopathy Grading Criteria.

Intrastromal voriconazole: An adjuvant approach for recalcitrant mycotic keratitis.

Purpose: To evaluate the efficacy of intrastromal voriconazole for the management of fungal keratitis not responding to conventional therapy. Methods: Patients having microbiologically proven fungal keratitis with poor response to 2 weeks of conventional topical therapy were included in the study. After obtaining informed consent, an intrastromal injection of voriconazole was administered around the ulcer. Response to treatment in the form reduction in the size of the ulcer and infiltration was recorded on regular follow-ups. Results: Out of a total of 20 patients, 14 responded to intrastromal treatment and resolved, whereas six patients progressed to perforation. Mean resolution time was 35.5 ± 9.2 days. The most common organism isolated was Fusarium in six patients while Aspergillus and Mucor were isolated in two each. The causative organism could not be isolated in eight patients. The size of the ulcer at presentation and height of hypopyon were found to be significant risk factors associated with treatment outcomes. Conclusion: Intrastromal voriconazole as an adjuvant therapy appeared to be effective in treatment of fungal keratomycosis not responding to conventional therapy, thus, reducing the need for therapeutic or tectonic keratoplasty.

Diet and inflammatory bowel disease: The Asian Working Group guidelines.

INTRODUCTION: These Asian Working Group guidelines on diet in inflammatory bowel disease (IBD) present a multidisciplinary focus on clinical nutrition in IBD in Asian countries. METHODOLOGY: The guidelines are based on evidence from existing published literature; however, if objective data were lacking or inconclusive, expert opinion was considered. The conclusions and 38 recommendations have been subject to full peer review and a Delphi process in which uniformly positive responses (agree or strongly agree) were required. RESULTS: Diet has an important role in IBD pathogenesis, and an increase in the incidence of IBD in Asian countries has paralleled changes in the dietary patterns. The present consensus endeavors to address the following topics in relation to IBD: (i) role of diet in the pathogenesis; (ii) diet as a therapy; (iii) malnutrition and nutritional assessment of the patients; (iv) dietary recommendations; (v) nutritional rehabilitation; and (vi) nutrition in special situations like surgery, pregnancy, and lactation. CONCLUSIONS: Available objective data to guide nutritional support and primary nutritional therapy in IBD are presented as 38 recommendations.

Effect of Cricoid Pressure on the Glottic View and Intubation with King Vision® Video Laryngoscope.

CONTEXT: To establish the usefulness of King Vision® video laryngoscope (KVL) in patients with rapid sequence anesthesia. AIMS: This study aims to compare the role of KVL on glottic visualization, intubation time and associated sympathetic response in routine intubations to those intubations done with cricoid pressure (CP). SETTINGS AND DESIGN: Randomized controlled study in a tertiary care hospital. METHODOLOGY: Seventy-six patients intubated with KVL were randomized to two groups - Group C (who did not receive any CP) and Group CP - who received CP. The percentage of glottic opening (POGO), intubation time, subjective assessment, and number of attempts taken to introduce KVL and endotracheal tube (ETT) were noted. The saturation, end-tidal carbon dioxide concentration and hemodynamic response (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and rate pressure product) in the peri-intubation period were also recorded. RESULTS: The demographics, airway, and technical characteristics of insertion of KVL and ETT were comparable between the groups (P > 0.05). POGO score was 100% in both groups. The significant time in insertion of KVL (Group C 29.87 ± 11.64 s and Group CP 40.68 ± 18.93 s, P = 0.004) and ETT (Group C 17.53 ± 8.71 s and Group CP 22.42 ± 10.77 s, P = 0.033) contributed to prolonged overall intubation time in CP (Group C 41.11 ± 11.65 s and Group CP 51.05 ± 17.31 s, P = 0.005). The intergroup and intragroup hemodynamic variables did not show any statistical significance (P > 0.05) over time. CONCLUSION: Although overall intubation time with KVL is prolonged in patients with CP, it provides excellent glottic view, eases intubation, and causes insignificant hemodynamic variation.

Shaping of infant B cell receptor repertoires by environmental factors and infectious disease.

Antigenic exposures at epithelial sites in infancy and early childhood are thought to influence the maturation of humoral immunity and modulate the risk of developing immunoglobulin E (IgE)-mediated allergic disease. How different kinds of environmental exposures influence B cell isotype switching to IgE, IgG, or IgA, and the somatic mutation maturation of these antibody pools, is not fully understood. We sequenced antibody repertoires in longitudinal blood samples in a birth cohort from infancy through the first 3 years of life and found that, whereas IgG and IgA show linear increases in mutational maturation with age, IgM and IgD mutations are more closely tied to pathogen exposure. IgE mutation frequencies are primarily increased in children with impaired skin barrier conditions such as eczema, suggesting that IgE affinity maturation could provide a mechanistic link between epithelial barrier failure and allergy development.

Correction to: Diet and inflammatory bowel disease: The Asian Working Group guidelines.

The recommendations 31 which recommend "VSL#3®", refer only to the product used in the cited literature and equivalent products independent from the present product labelings. This product is now known by the generic name "De Simone Formulation".

Cranio-spinal Rosai Dorfman disease: case series and literature review.

Rosai-Dorfman disease (RDD) is a rare condition similar to lymphomas, presenting with cervical lymphadenopathy in young adults. Extra-nodal involvement is relatively common but involvement of the central nervous system (CNS) is rare. Cranial RDD presents with symptoms of raised intracranial pressure, focal or generalised seizures, while spinal RDD presents with pain, peripheral neurological deficits and radiculopathy. In contrast to other similar neoplastic or degenerative conditions affecting the CNS, RDD is a benign, non-infective, granulomatous disorder. Radiologically cranio-spinal RDD often mimics commoner dural-based lesions like meningioma, with only subtle radiological differentiating findings on Magnetic Resonance Imaging (MRI). The histopathology of RDD is diagnostic. Surgical excision is preferred modality of treatment. However, adjuvant therapies like steroids and radiation may help controlling residual or recurrent disease. There are multiple sporadic reports and short case publications in the literature, often focusing on a particular aspect of RDD. In this study, authors aim to present five cases of craniospinal RDD, and comprehensive review of literature and highlight neurological complications of systemic RDD.

A review on exudates detection methods for diabetic retinopathy.

The presence of exudates on the retina is the most characteristic symptom of diabetic retinopathy. As exudates are among early clinical signs of DR, their detection would be an essential asset to the mass screening task and serve as an important step towards automatic grading and monitoring of the disease. Reliable identification and classification of exudates are of inherent interest in an automated diabetic retinopathy screening system. Here we review the numerous early studies that used for automatic exudates detection with the aim of providing decision support in addition to reducing the workload of an ophthalmologist.