Real-World User and Clinician Perspective and Experience with MiniMed™ 780G Advanced Hybrid Closed Loop System.

INTRODUCTION: The advanced hybrid closed loop (AHCL) MiniMed™ 780G system changes basal insulin delivery every 5 min and auto bolus in response to sensor glucose values. We assessed the performance of the AHCL system in real-world settings for individuals with type 1 diabetes (T1DM) as well as user and clinician perspectives and satisfaction. METHODS: We held two peer group discussions: one having adults with T1DM/parents of children and adolescents with T1DM to understand their experiences with the AHCL system and another with healthcare providers (HCPs). Responses from the discussions were analyzed and categorized into themes by two independent researchers, with any inconsistencies resolved by consensus. We also analyzed data from the system uploaded to CareLink personal software. Glycemic outcomes, including time in range (TIR), time below range (TBR), time above range (TAR), mean sensor glucose (SG) levels, glucose management indicator (GMI), sensor use, and percentage of time spent in AHCL, were determined. RESULTS: The peer group discussions revealed numerous key themes and issues for each group, such as the significance of setting reasonable expectations, carbohydrate counting and bolus dosing, technical difficulties, and overall user experience. The users (n = 25; T1DM; 17 female; age 13.8 ± 7.49 years; A1C 6.54 ± 0.45%; duration of diabetes 6 ± 6.78 years) were very satisfied with the system. Most users experienced consistent blood glucose values with very few hypoglycemic episodes. However, there were a few limitations reported, such as hyperglycemic episodes caused by inaccuracies in carb counting, issues with sensor connectivity, and cannula blockages or kinking for those using insulin Fiasp. Users achieved a mean GMI of 6.4 ± 0.26%, TIR of 83.0 ± 8.12%, TBR (54-70 mg/dL) of 2.0 ± 0.81%, TBR* (< 54 mg/dL) of 0%. All of the users achieved a TIR of > 70%. CONCLUSION: The use of the AHCL system in T1DM resulted in robust glycemic control, minimizing hypoglycemia. Providing training to both users and HCPs can help them use the system effectively.

Comparing the benefits of applying a vacuum assisted lancing device in reducing lancing pain, improving self-monitoring frequency and reducing HbA1c in people with diabetes.

BACKGROUND AND AIMS: For most people with diabetes (PwD), lancing fingertips for obtaining a blood sample is unavoidable during blood glucose monitoring (BGM). This study investigated the potential benefits of applying a vacuum over the penetration site immediately, before, during, and after lancing to determine if a vacuum would allow a less painful lancing process from fingertips and alternate sites, while still drawing sufficient blood, thereby allowing PwD to have a painless lancing experience and improving self-monitoring frequency. The cohort was encouraged to use a commercially available vacuum assisted lancing device. Change in pain perception, testing frequency, HbA1c, and future probability of VALD use were determined. METHODS: In a 24-week randomized open-label, interventional, cross-over trial, 110 PwD were recruited who used VALD and non-vacuum conventional lancing devices, for 12 weeks each. Percentage reduction in HbA1c, percentage BGM adherence, scores of pain perception, and probability of selecting VALD in the future were measured and compared. RESULTS: There was reduction in overall HbA1c values (mean ± SD), (from 9.01 ± 1.68% at baseline to 8.28 ± 1.66%) and individually in T1D (from 8.94 ± 1.77% to 8.25 ± 1.67%) and T2D (from 8.31 ± 1.17% to 8.59 ± 1.30) after using VALD for 12 weeks. Lower pain perception and high probability of using VALD over conventional devices were observed. CONCLUSION: The study highlights the benefits of applying a vacuum to the lance site which enhances the effectiveness in reducing and eliminating pain, improving self-monitoring frequency, and lowering HbA1c over non-vacuum conventional devices.

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.

A new interventional home care model for COVID management: Virtual Covid IP.

AIM: Amidst COVID-19 pandemic, the health care delivery in India faces major challenges owing to the overwhelming hospitals, exhausted healthcare workers, and shortage of crucial medical supplies such as ventilators and oxygen. The study aims to propose a novel successful interventional home care model, the Virtual COVID In-Patient (VCIP) care for effective COVID management. METHODS: The Covid-19 positive patients enrolled in VCIP were chosen for the study. A 24/7 active multidisciplinary WhatsApp group was created for each patient, for remote monitoring of temperature, blood pressure, blood glucose, respiratory and pulse rate along with the symptoms. Advice on sleep and exercises were given along with the medication via video-audio consultations. Lab facility was provided at the doorstep. Training on various devices, medications including steroids, delivering subcutaneous injections etc were given via video platforms. RESULTS: Among the 220 patients who availed the VCIP facility, only two were hospitalized, yielding a 99.5 % success rate in preventing hospitalizations and patients enrolled have been immensely satisfied with their experience. CONCLUSIONS: With similar pandemics anticipated in near future, VCIP model may be considered for successful domiciliary treatment and overcoming the challenges.

Sitagliptin 100 mg vs glimepiride 1-3 mg as an add-on to insulin and metformin in type 2 diabetes (SWIM).

OBJECTIVE: To compare the effect of sitagliptin (100 mg) vs glimepiride (1-3 mg) as add-on therapy in Indian type 2 diabetes (T2DM) patients on treatment with insulin and metformin (SWIM study). RESEARCH DESIGN AND METHODS: This 24-week, controlled, open-label study randomized T2DM patients (n = 440) receiving a stable dose of metformin and insulin combination therapy to sitagliptin (100 mg) or glimepiride (1-3 mg) as add-on therapy. Baseline HbA1c was ≥7.3% and ≤8.5%. After a 6-week titration period for glimepiride (dose titrated every 2 weeks by 1 mg up to a maximum of 3 mg daily), patients were continued for 18 weeks on their respective tolerable doses of glimepiride (ranging from 1 mg to 3 mg) or sitagliptin (100 mg) along with metformin and insulin. RESULTS: Greater reductions in HbA1c and TDD of insulin were achieved with sitagliptin compared to glimepiride. HbA1c targets and reductions in TDD were achieved by more patients on sitagliptin than on glimepiride. Reductions in both body weight and BMI were also noted among patients on sitagliptin when compared to those on glimepiride, and more hypoglycemic events occurred with glimepiride treatment than with sitagliptin. CONCLUSIONS: Sitagliptin (100 mg), when compared to glimepiride (1-3 mg), bestowed beneficial effects to T2DM patients in terms of achieving greater glycemic control and also brought significant reductions in total daily dose of insulin required, bodyweight, BMI and hypoglycemic events. Overall, the results suggest that sitagliptin (100 mg) is a superior agent over glimepiride (1-3 mg) as an add-on to insulin-metformin therapy among Asian Indians with T2DM.

Assessing the Therapeutic Utility of Professional Continuous Glucose Monitoring in Type 2 Diabetes Across Various Therapies: A Retrospective Evaluation.

BACKGROUND: There have been few large studies that have analyzed the effect of professional (masked) continuous glucose monitoring (P-CGM) on glycemic control in patients with type 2 diabetes (T2DM) who were on a broad spectrum of baseline therapies. METHODS: We performed a retrospective, blinded evaluation of glycemic control in 296 T2DM adults for 6 months following a 6- to 7-day study of their glycemic profile using masked P-CGM. At baseline, 91% of the patients were on some form of insulin treatment with oral hypoglycemic agents (OHA), while 7% were on one or more OHAs without insulin, and the remaining 2% were on GLP-1RAs. On the basis of the masked CGM profile, patients were counselled on diet and exercise change(s) in their baseline diabetes therapy by our professionally trained diabetes team. They also continued to receive regular treatment advice and dose titrations through our Diabetes Tele-Management System (DTMS®). The baseline changes in hemoglobin A1C (A1C) observed in these patients after 6 months of undergoing P-CGM was compared to a matched control group. RESULTS: P-CGM revealed that the predominant pattern of hyperglycemia was postprandial while previously unknown hypoglycemia was found in 38% of the patients; over half of the cases of hypoglycemia were nocturnal. The mean A1C of the P-CGM group dropped from 7.5 ± 1.4% at baseline vs. 7.0 ± 0.9% at 6 months (p < 0.0001). The frequency of performing self-monitoring of blood glucose (SMBG) was also found to be significantly increased in these patients from the baseline. Meanwhile, no significant improvement in A1C was noted in the control group during the same time frame (7.7 ± 1.1% at baseline vs. 7.4 ± 1.1% at 6 months; p = 0.0663) and frequency of SMBG remained almost unchanged. CONCLUSIONS: P-CGM can provide actionable data and motivate patients for diabetes self-care practices, resulting in an improvement in glycemic control over a wide range of baseline therapies.

The two levels of care for diabetes in a developing country: Mechanisms for improved intermediate health outcomes.

India has over 70 million citizens with diabetes, the second-most of any country worldwide. Disparities in learning skills, resources, education, and physician practices make it difficult to practically implement the diabetes management guidelines recommended by international scientific organizations. In its guidelines, the International Diabetes Federation advocates for three different levels of care based on availability of resources. This study investigates the differences in intermediate health outcomes between two diabetes care programs: one a comprehensive diabetes centre, the other a limited care setting. The comprehensive centre offers telemedicine and periodic diabetes education, empowering patients and providing 24-hour advice on lifestyle modifications, diet, and exercise. All patients of this centre practice self-monitoring of blood glucose. The subjects in the limited care setting receive minimal investigations and periodic physical follow-ups, and few patients have access to home glucose monitoring. The results showed that HbA1c (7.62 vs. 8.58, p=0.003), cholesterol (134.4 vs. 173.4, p<0.001), and diastolic blood pressure (72.9 vs. 77.0, p=0.016) were significantly lower in patients receiving comprehensive care, while the reductions in systolic blood pressure (134.6 vs. 138.7, p=0.202) did not achieve statistical significance. These reductions, which remained significant after correcting for confounding factors, could be attributed to more aggressive treatment regimens in the comprehensive care centre, as well as the real-time, frequent communication with medical professionals in the telemedicine program.

CSII as an Alternative Therapeutic Strategy for Managing Type 2 Diabetes: Adding the Indian Experience to a Global Perspective.

BACKGROUND: Alternative insulin therapy with continuous subcutaneous insulin infusion (CSII) is offered with an objective of achieving better glycemic control, minimising glucose variability and thereby, preventing or reducing the risk of microvascular and macrovascular complications in people with type 1 or type 2 diabetes. Trials conducted across the world have demonstrated that CSII is more beneficial in terms of achieving better metabolic control in type 2 diabetes. Unawareness about the multiple benefits of CSII is a major hurdle to its widespread use. In India, insulin pumps are more popular in type 2 diabetes and we have been deploying pumps since 2004. Previously, we have reported reduction in HbA1c, body weight and total daily dose of insulin in patients on insulin pump therapy (IPT). OBJECTIVE: The objective of this study was to assess the attitude and behavior of type 2 diabetes patients on IPT. METHODS: A cross sectional survey was conducted among selected type 2 diabetes patients who have been on IPT for more than 3 years. We administered questionnaires to assess level of satisfaction with pump, improvement in quality of life (QoL), use of the advanced functions and average cost incurred by being on pump. Difference in scores between males and females were assessed using chiquare test for proportions and t-test for differences in means. RESULTS: Improvement in QoL after being on pump was appreciated by 92%. The level of satisfaction was rated as 'fully satisfied' by 52% of respondents while 26% found being on pump, 'satisfactory'. Ninety percent thought that the pump met their expectations. CONCLUSION: The attitude and behavior of type 2 diabetes patients on IPT is positive and promising.

Efficacy and safety of liraglutide therapy in 195 Indian patients with type 2 diabetes in real world setting.

BACKGROUND: GLP-1 analogues has established role in the management of type 2 diabetes mellitus (T2DM). Liraglutide, a human GLP-1 analogue is used as an adjunct to diet and exercise in adults with T2DM for improvement of glycemic control. OBJECTIVE: To assess the efficacy and safety of liraglutide in Indian patients with T2DM in real-world setting. METHODS: A prospective, open label, single arm, single centre, observational study of 24 weeks duration in a real-world setting. Subjects with T2DM with impaired glucose control despite of antidiabetic therapy and clinically suitable for liraglutide therapy were enrolled and managed. All subjects received liraglutide therapy in addition to their existing anti-diabetic therapy. Starting dose of liraglutide (Victoza) was 0.6 mg/day for 7 days followed by 1.2 mg/day for next 7 days and finally 1.8 mg/day for 22 weeks. Subjects were evaluated at baseline and at 24 weeks. Adverse events (AE) noted during course of therapy were recorded. Student t test (two tailed, dependent) was performed for assessment of statistical significance. RESULTS: Total 195 subjects were studied over 24 weeks. Mean fasting plasma glucose (FPG) was decreased from 163.81 mg/dL to 111.6 (P<0.001); similarly HbA1c was reduced from 8.14% to 6.96% (P=0.006) at 24 weeks. At week 24, 49.23% and 41.03% subjects treated with liraglutide reached an HbA1c<7.0% and ≤6.5%, respectively. Mean weight was reduced from 86.41 kg to 82.37 kg (P<0.001). Additionally mean systolic and diastolic blood pressure was reduced from 129.31 and 76.18 mm of Hg to 119.59 (P=0.90) and 70.88 (P<0.001) mm of Hg, respectively. Serum cholesterol was reduced from 166.68 mg/dL to 124.86 mg/dL (P<0.001). Twenty-two (11.28%) subjects reported adverse events (AE), the most common AEs being vomiting, tiredness, loose motion and nausea. All AEs were mild to moderate in nature without any serious AE. CONCLUSION: In 195 Indian patients with T2DM receiving anti-diabetic drugs, addition of liraglutide resulted in significant improvement in glycemic parameters and was well tolerated. Clinically significant reduction in weight, blood pressure and serum cholesterol were also noted.

Telemedicine for diabetes care: An Indian perspective - feasibility and efficacy.

Diabetes is a chronic and costly disease. In India, the usual practice among patients is to visit the doctor once in every 2-3 months to get advice on changes in the dosages of medications. The Diabetes Tele Management System (DTMS(®)) is a telemedicine based follow-up program originally introduced at Jothydev's Diabetes Research Centre at Trivandrum South India in 1998. It is a chronic disease management system which enables patient to interact lively with a professionally trained multidisciplinary team comprising of diabetes educators, nurses, dieticians, pharmacists, psychologists, physicians, etc., in modifying the dosages of medications, diet, and physical activity either through telephone/email/secure website. The uniquely designed software and the trained multidisciplinary team overcomes the globally recognized major barriers to diabetes management namely fear of hypoglycemia, polypharmacy, discontinuation of stains, and antihypertensives or wrong injection techniques. DTMS is designed to provide individualized therapy advices on glycosylated hemoglobin, blood pressure, and low density lipoprotein customized to multiple patient characteristics which help attain goals of therapy. The system has been tested on various platforms over a decade and was shown to be a patient friendly approach with successful outcomes due to a live "round-the-clock" interactive communication in contrast to text or recorded messages. The major challenge to the widespread use of DTMS(®) is seeking a source of funding this unique telemedicine program.

Liraglutide therapy beyond glycemic control: an observational study in Indian patients with type 2 diabetes in real world setting.

BACKGROUND: Liraglutide is an analog of human glucagon-like peptide-1 (GLP-1) and acts as a GLP-1 receptor agonist. Liraglutide is presently used in the treatment of selected patients with type 2 diabetes mellitus (T2DM). OBJECTIVE: To assess efficacy and safety of liraglutide in, overweight and obese Indian patients with T2DM. METHODS: A single center, prospective, open-labeled, single-arm, observational study for 24 weeks in a real-world setting. Fourteen overweight and obese patients with T2DM who were clinically suitable for liraglutide therapy received liraglutide injections. The starting dose of liraglutide (Victoza) injection was 0.6 mg/day for 3 days followed by 1.2 mg for next 10 days and finally 1.8 mg/day for 22 weeks. Patients were evaluated at baseline and after 12 and 24 weeks of therapy. Adverse events (AE) noted during course of therapy were recorded. A repeated measure analysis of variance was performed to assess statistical significance. RESULTS: Fourteen patients were studied for 24 weeks. After 24 weeks of liraglutide therapy, mean fasting and postprandial plasma glucose decreased by 48.5 mg/dL and 66.71 mg/dL, respectively (P = 0.002 and P = 0004 over 24 weeks, respectively). A mean reduction of 2.26% of glycosylated hemoglobin was noted (P < 0.001 over 24 weeks). Mean decrease in body weight of 8.65 kg and mean decrease in body mass index of 3.26 kg/m(2) was noted (P < 0.001 over 24 weeks for each parameter). Systolic blood pressure was reduced by 15.15 mm of Hg (P = 0.004). Significant improvement in total cholesterol, low-density lipoprotein, triglycerides, and serum creatinine was noted. Nine patients reported AEs. The AEs noticed were nausea (n = 6), feeling of satiety (n = 3), and vomiting (n = 1). No serious AE or hypoglycemic episodes were observed. CONCLUSION: Liraglutide once a day improved overall glycemic control and was well tolerated. Clinically significant reduction in body weight, systolic blood pressure and improvement in lipid profile were noticed with liraglutide therapy in addition to glycemic control.

Cost-effective use of telemedicine and self-monitoring of blood glucose via Diabetes Tele Management System (DTMS) to achieve target glycosylated hemoglobin values without serious symptomatic hypoglycemia in 1,000 subjects with type 2 diabetes mellitus--a retrospective study.

OBJECTIVE: This study assessed the effectiveness, safety, and costs of the Diabetes Tele Management System (DTMS(®); Dr. Jothydev Kesavadev, Jothydev's Diabetes and Research Center, Kerala, India)-based health care in type 2 diabetes (T2D) patients in South India. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study using electronic health records in our Center. The study sample comprised T2D patients enrolled in DTMS-based management, 30-75 years old, eligible for a glycosylated hemoglobin (HbA1c) target <6.5% and actively participating in various components of DTMS such as regular reporting of self-monitoring of blood glucose (SMBG) values and dose adjustments via telemedicine. We analyzed HbA1c, lipid profile, and other parameters measured at the first visit and on subsequent physical visits at months 3 and 6 and estimated the incidence of hypoglycemia. RESULTS: We analyzed records of 1,000 subjects with 6-month follow-up data (mean age, 53.2 ± 9.8 years; 64% male). Patients had an average of 17 ± 2 telemedicine follow-ups and reported 66,745 SMBG values over 6 months. The mean ± SD HbA1c value was 8.5 ± 1.4% at the initial visit and was reduced to 6.3 ± 0.6% at 6 months (P<0.0001). The rate of SMBG values <70 mg/dL was approximately 0.04/patient/month, with 84% patients reporting no hypoglycemia. The recurring extra cost to patient for DTMS, not considering cost of oral drugs and insulin, was equivalent to 9.66 U.S. dollars/month. CONCLUSIONS: DTMS, based on telemedicine follow-up and multidisciplinary care with SMBG-based monitoring, appears to be safe and cost-effective in the intensive treatment of T2D without serious co-morbidities. This system also avoids limitations of a traditional health care such as the need for very frequent physical visits for each and every drug dose adjustment, diet, and exercise advice.

An Asian Indian woman with Wolfram syndrome on insulin pump: successful pregnancy and beyond.

Wolfram syndrome (WS), or DIDMOAD (diabetes insipidus, diabetes mellitus, optic atrophy, and deafness), is a rare autosomal recessive neurodegenerative disorder with a median life expectancy of 30 years and occurs in one in 770,000 live births. To date only five successful pregnancies have been reported among WS subjects worldwide. Here we describe the sixth report of successful pregnancy in a WS patient and the first from India. The subject is still on an insulin pump, now 31 years old and doing well. She developed diabetes at 5 years of age, optic atrophy at 14 years, and diabetes insipidus at 25 years and had a successful delivery in 2007 while on an insulin pump. Sequencing of exonic regions of the WFS1 gene showed five changes, two of which were pathogenic (exon 8). Magnetic resonance imaging of brain showed generalized neurodegenerative changes. The benefits of continuous subcutaneous insulin infusion and that of tight metabolic control in prevention of abortions and fetal malformations in diabetes associated with pregnancy are well documented. The impression of probable pleiotropic action of insulin pumps over and above that of glycemic reduction is gaining momentum. Recent evidence supports use of insulin pumps in alleviating neuropathic pain in diabetes, probably by virtue of its action in minimizing mean amplitude of glycemic excursions not possible with conventional insulin shots. WS is a progressive neurodegenerative disorder, which will probably help us in understanding the positive impact of continuous subcutaneous insulin infusion in prolonging the life span and retarding neuronal damage in WS.

Use of insulin pumps in India: suggested guidelines based on experience and cultural differences.

All type 1 diabetes mellitus (T1DM) subjects and the majority of type 2 diabetes mellitus (T2DM) subjects at one time or another require insulin to sustain life. Syringes and pens are presently the most popular insulin delivery devices. Though in use for more than 3 decades, insulin pumps are now being more commonly used because of their unique ability to continuously infuse insulin, closely mimicking that of physiological secretion from a normal pancreas. Unlike insulin shots with syringes, pump infusion sites need to be changed less frequently. Scientific evidence from published studies have proven added benefit of insulin pumps in improving quality of life, normalizing sugars in recalcitrant diabetes, improving sexual function, and relieving the intractable pain of neuropathy. In the western world, pumps are commonly used with T1DM subjects, whereas in India 80% of pumpers are T2DM subjects. The success of insulin pump therapy depends on selection of the right candidate, extensive education, motivation, and implementing the sophisticated programs with skill. However, all affordable patients are not ideal candidates for pump therapy because for successful continuation of pump therapy other inclusion criteria should also be fulfilled. Among the other indications discussed are a high level of insulin resistance, brittle diabetes, chronic kidney disease on renal replacement therapy, and continuous glucose monitoring pattern strongly suggesting need for a variable basal insulin infusion rate. In International Diabetes Foundation data released in 2009, estimated diabetes prevalence for 2010 is 285 million, representing 6.4% of the world's adult population, with a prediction that by 2030 the number of people with diabetes will have increased to 438 million. Considering this massive growth in T2DM and its propensity after 10­15 years to lead to an insulin-deficient state, available evidence from studies is a compelling indication not to deny the benefits of continuous subcutaneous insulin infusion in selected T2DM subjects. This article aims at suggesting guidelines based on clinical experience and cultural diversity for India and developing countries.

Reduction of glycosylated hemoglobin following 6 months of continuous subcutaneous insulin infusion in an Indian population with type 2 diabetes.

BACKGROUND: The standard treatment regimen for insulin-dependent type 2 diabetes is multiple daily injections (MDI) of insulin, but continuous subcutaneous insulin infusion (CSII) with an insulin pump offers more flexibility and the possibility of a reduced total daily insulin dose. Few studies have investigated CSII for type 2 diabetes, and none has focused on an Asian Indian population. METHODS: Subjects with type 2 diabetes who were previously using MDI were switched to CSII. Glycosylated hemoglobin (HbA1c), body weight, and total daily insulin dose were recorded at baseline (MDI) and after 6 months of CSII. Subjects were also asked to rate their satisfaction with CSII and the treatment's interference in their daily activities after 6 months. RESULTS: A total of 46 subjects received CSII. Mean HbA1c was reduced by 0.5% after 6 months. This outcome was statistically significant (P < 0.0063; 95% confidence interval, 0.161-0.921%). There was no statistically significant change in body weight or total insulin daily dose. Subjects reported high satisfaction with CSII and low interference with daily activities. CONCLUSIONS: Six months of CSII in Asian Indian subjects with type 2 diabetes resulted in a statistically and clinically significant change in HbA1c.