Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes.

Importance: Continuous glucose monitoring (CGM) is recommended for patients with type 1 diabetes; observational evidence for CGM in patients with insulin-treated type 2 diabetes is lacking. Objective: To estimate clinical outcomes of real-time CGM initiation. Design, Setting, and Participants: Exploratory retrospective cohort study of changes in outcomes associated with real-time CGM initiation, estimated using a difference-in-differences analysis. A total of 41 753 participants with insulin-treated diabetes (5673 type 1; 36 080 type 2) receiving care from a Northern California integrated health care delivery system (2014-2019), being treated with insulin, self-monitoring their blood glucose levels, and having no prior CGM use were included. Exposures: Initiation vs noninitiation of real-time CGM (reference group). Main Outcomes and Measures: Ten end points measured during the 12 months before and 12 months after baseline: hemoglobin A1c (HbA1c); hypoglycemia (emergency department or hospital utilization); hyperglycemia (emergency department or hospital utilization); HbA1c levels lower than 7%, lower than 8%, and higher than 9%; 1 emergency department encounter or more for any reason; 1 hospitalization or more for any reason; and number of outpatient visits and telephone visits. Results: The real-time CGM initiators included 3806 patients (mean age, 42.4 years [SD, 19.9 years]; 51% female; 91% type 1, 9% type 2); the noninitiators included 37 947 patients (mean age, 63.4 years [SD, 13.4 years]; 49% female; 6% type 1, 94% type 2). The prebaseline mean HbA1c was lower among real-time CGM initiators than among noninitiators, but real-time CGM initiators had higher prebaseline rates of hypoglycemia and hyperglycemia. Mean HbA1c declined among real-time CGM initiators from 8.17% to 7.76% and from 8.28% to 8.19% among noninitiators (adjusted difference-in-differences estimate, -0.40%; 95% CI, -0.48% to -0.32%; P < .001). Hypoglycemia rates declined among real-time CGM initiators from 5.1% to 3.0% and increased among noninitiators from 1.9% to 2.3% (difference-in-differences estimate, -2.7%; 95% CI, -4.4% to -1.1%; P = .001). There were also statistically significant differences in the adjusted net changes in the proportion of patients with HbA1c lower than 7% (adjusted difference-in-differences estimate, 9.6%; 95% CI, 7.1% to 12.2%; P < .001), lower than 8% (adjusted difference-in-differences estimate, 13.1%; 95% CI, 10.2% to 16.1%; P < .001), and higher than 9% (adjusted difference-in-differences estimate, -7.1%; 95% CI, -9.5% to -4.6%; P < .001) and in the number of outpatient visits (adjusted difference-in-differences estimate, -0.4; 95% CI, -0.6 to -0.2; P < .001) and telephone visits (adjusted difference-in-differences estimate, 1.1; 95% CI, 0.8 to 1.4; P < .001). Initiation of real-time CGM was not associated with statistically significant changes in rates of hyperglycemia, emergency department visits for any reason, or hospitalizations for any reason. Conclusions and Relevance: In this retrospective cohort study, insulin-treated patients with diabetes selected by physicians for real-time continuous glucose monitoring compared with noninitiators had significant improvements in hemoglobin A1c and reductions in emergency department visits and hospitalizations for hypoglycemia, but no significant change in emergency department visits or hospitalizations for hyperglycemia or for any reason. Because of the observational study design, findings may have been susceptible to selection bias.

Diabetes Healthcare Professionals Use Multiple Continuous Glucose Monitoring Data Indicators to Assess Glucose Management.

BACKGROUND: Continuous glucose monitoring (CGM) offers multiple data features that can be leveraged to assess glucose management. However, how diabetes healthcare professionals (HCPs) actually assess CGM data and the extent to which they agree in assessing glycemic management are not well understood. METHODS: We asked HCPs to assess ten de-identified CGM datasets (each spanning seven days) and rank order each day by relative glycemic management (from "best" to "worst"). We also asked HCPs to endorse features of CGM data that were important in making such assessments. RESULTS: In the study, 57 HCPs (29 endocrinologists; 28 diabetes educators) participated. Hypoglycemia and glycemic variance were endorsed by nearly all HCPs to be important (91% and 88%, respectively). Time in range and daily lows and highs were endorsed more frequently by educators (all Ps < .05). On average, HCPs endorsed 3.7 of eight data features. Overall, HCPs demonstrated agreement in ranking days by relative glycemic control (Kendall's W = .52, P < .001). Rankings were similar between endocrinologists and educators (R2 = .90, Cohen's kappa = .95, mean absolute error = .4 [all Ps < .05]; Mann-Whitney U = 41, P = .53). CONCLUSIONS: Consensus in the endorsement of certain data features and agreement in assessing glycemic management were observed. While some practice-specific differences in feature endorsement were found, no differences between educators and endocrinologists were observed in assessing glycemic management. Overall, HCPs tended to consider CGM data holistically, in alignment with published recommendations, and made converging assessments regardless of practice.

Frequency of self-monitoring of blood glucose in relation to weight loss and A1C during intensive multidisciplinary weight management in patients with type 2 diabetes and obesity.

Objective: We evaluated the relationship between frequency of self-monitoring of blood glucose (SMBG) and body weight, A1C, and cardiovascular risk factors in patients with type 2 diabetes (T2D) and obesity enrolled in a 12-week intensive multidisciplinary weight management (IMWM) program. Research design and methods: We conducted a retrospective analysis of 42 patients who electronically uploaded their SMBG data over 12 weeks of an IMWM program and divided them into tertiles based on their average frequency of SMBG per day. Mean (range) SMBG frequencies were 2.3 (1.1-2.9) times/day, 3.4 (3-3.9) times/day, and 5 (4-7.7) times/day in the lowest, middle, and highest tertiles, respectively. Anthropometric and metabolic parameters were measured at baseline and after 12 weeks of intervention. Results: Participants in the highest tertile achieved a median change (IQR) in body weight of -10.4 kg (-7.6 to -14.4 kg) compared with -8.3 kg (-5.2 to -12.2 kg), and -6.9 kg (-4.2 to -8.9 kg) in the middle and lowest tertiles, respectively (p=0.018 for trend). Participants in the highest tertile had a median change (IQR) in A1C of -1.25% (-0.6 to -3.1%) compared with -0.8% (-0.3% to -2%) and -0.5% (-0.2% to -1.2%) in the middle and lowest tertiles, respectively (p=0.048 for trend). The association between change in body weight and SMBG frequency remained significant after adjusting for age, sex, baseline body mass index, diabetes duration, and use of insulin therapy. Conclusions: Increased frequency of SMBG during IMWM is associated with significantly better weight loss and improvement of A1C in patients with T2D and obesity. These findings may suggest future clinical recommendations aimed at increasing SMBG frequency to achieve the most favorable outcomes.

Mindfulness and fear of hypoglycaemia in parents of children with Type 1 diabetes: results from Diabetes MILES Youth - The Netherlands.

AIMS: To identify the sociodemographic and clinical correlates of fear of hypoglycaemia among parents of children (aged 4-18 years) with Type 1 diabetes and to examine the relationships between parental fear of hypoglycaemia, mindfulness and mindful parenting. METHODS: Sociodemographic, self-reported clinical and psychological data were extracted from the cross-sectional Diabetes MILES Youth - The Netherlands dataset. Questionnaires included the Hypoglycaemia Fear Survey - Parent Worry (parental fear of hypoglycaemia), the Freiburg Mindfulness Inventory - Short version (mindfulness) and the Interpersonal Mindfulness in Parenting Scale (mindful parenting). RESULTS: A total of 421 parents (359 mothers) participated. Hierarchical linear regression analyses showed that greater parental fear of hypoglycaemia was related to younger parental age, low educational level, non-Dutch nationality, more frequent blood glucose monitoring, and less general mindfulness. Adding mindful parenting to the model negated the previous contribution of general mindfulness. In this model, lower mindful parenting was related to greater parental fear of hypoglycaemia. In particular, parents with an increased ability to be less judgemental of themselves as parents and less reactive to emotions within parenting interactions reported less fear of hypoglycaemia. In total, 21% of the variance in parental fear of hypoglycaemia was explained. CONCLUSION: Parental fear of hypoglycaemia was associated largely with parental characteristics, including non-modifiable sociodemographics (i.e. age, education, nationality) and modifiable psychological factors (i.e. mindful parenting). These findings suggest that it is important to further explore mindfulness-based interventions for parents to reduce fear of hypoglycaemia next to interventions to reduce hypoglycaemia.

Efectividad e impacto económico de un programa de atención integrada con soporte de telemedicina a pacientes diabéticos tipo 2 tratados con insulina (estudio GITDIABE) / Effectiveness and economic impact of a program of integrated care with telemedicine support on insulin-treated type 2 diabetic patients (Study GITDIABE)

OBJETIVO: Evaluar si pacientes diabéticos tipo 2 con insulina y autocontrol (DIA) incluidos en un programa de gestión integrada de la diabetes mellitus (DM) con seguimiento telemático alcanzan un grado de control metabólico a los 12 meses mejor que los no incluidos, así como el impacto en la utilización y el coste de servicios sanitarios, consumo de fármacos y tiras reactivas. DISEÑO: Estudio prospectivo de cohortes paralelas. Emplazamiento: Cuatro áreas básicas de salud de una organización sanitaria integrada. PARTICIPANTES: Ciento veintiséis pacientes DIA de 15 o más años en tratamiento con insulina rápida o intermedia con autocontroles: 42 casos y 84 controles emparejados según edad, sexo, grado de control de la DM y perfil de morbilidad. Intervención: Comunicación telemática médico-paciente y volcado de glucemias mediante la plataforma Emminens eConecta®; suministro a domicilio de tiras reactivas según consumo. Controles ocultos, con seguimiento habitual. Mediciones principales: Hemoglobina glucosilada (% HbA1c); percepción de calidad de vida (EuroQol-5 y EsDQOL); riesgo cardiovascular; utilización de recursos sanitarios; consumo de tiras reactivas y medicamentos; gasto sanitario total. RESULTADOS: Reducción de %HbA1c en casos respecto a controles de 0,38% (IC95% −0,89% a 0,12%). Sin diferencias significativas respecto a ninguna de las actividades registradas, ni cambios significativos en la calidad de vida. CONCLUSIONES: Los resultados obtenidos no difieren de otros estudios equiparables. El perfil es de un paciente anciano y pluripatológico que tiene todavía limitaciones tecnológicas. Para superar estas barreras se debería dedicar más tiempo a la formación y a la resolución de problemas tecnológicos

AIM: To evaluate if insulin-treated type 2 diabetic patients with blood glucose self-monitoring (DIA), included in a program of integrated management of diabetes mellitus (DM), achieve a better level of metabolic control with telemedicine support than with conventional support, after 12 months follow-up. The impact on the use and cost of healthcare services, pharmaceutical expenditure, and consumption of test strips for blood glucose, was also assessed. DESIGN: A prospective parallel cohorts study. Field: Four basic health areas of an integrated healthcare organisation. PARTICIPANTS: The study included 126 DIA patients aged 15 or more years, treated with rapid or intermediate Insulin and blood glucose self-monitoring, grouped into 42 cases and 84 controls, matched according to age, sex, level of metabolic control, and morbidity profile. Intervention: Telematics physician-patient communication and download of blood glucose self-monitoring data through the Emminens eConecta® platform; test strips home delivered according to consumption. Hidden controls with usual follow-up. MAIN MEASUREMENTS: Glycosylated haemoglobin (%HbA1c); perception of quality of life (EuroQol-5 and EsDQOL); cardiovascular risk; use of healthcare resources; consumption of test strips; pharmaceutical and healthcare expenditure. RESULTS: Reduction of 0.38% in HbA1c in the cases (95% CI:−0.89% to 0.12%). No significant differences with regard to any of the activities registered, or any significant change in the quality of life. CONCLUSIONS: The results obtained are similar to other equivalent studies. The profile of the patient is elderly and with multiple morbidities, who still have technological limitations. To surpass these barriers, it would be necessary to devote more time to the training and to the resolution of possible technological problems

Association of Patient-Physician Language Concordance and Glycemic Control for Limited-English Proficiency Latinos With Type 2 Diabetes.

Importance: Providing culturally competent care to the growing number of limited-English proficiency (LEP) Latinos with diabetes in the United States is challenging. Objective: To evaluate changes in risk factor control among LEP Latinos with diabetes who switched from language-discordant (English-only) primary care physicians (PCPs) to language-concordant (Spanish-speaking) PCPs or vice versa. Design, Setting, and Participants: This pre-post, difference-in-differences study selected 1605 adult patients with diabetes who self-identified as Latino, whose preferred language was Spanish, and who switched PCPs between January 1, 2007, and December 31, 2013. Study participants were members of the Kaiser Permanente Northern California health care system (an integrated health care delivery system with access to bilingual PCPs and/or professional interpreter services). Spanish-speaking and English-only PCPs were identified by self-report or utilization data. Exposures: Change in patient-PCP language concordance after switching PCPs. Main Outcomes and Measures: Glycemic control (glycated hemoglobin [HbA1c] < 8%), poor glycemic control (HbA1c > 9%), low-density-lipoprotein (LDL) control (LDL < 100 mg/dL), and systolic blood pressure (SBP) control (SBP < 140 mm Hg). Results: Overall, 1605 LEP Latino adults with diabetes (mean [SD] age, 60.5 [13.1] years) were included in this study, and there was a significant net improvement in glycemic and LDL control among patients who switched from language-discordant PCPs to concordant PCPs relative to those who switched from one discordant PCP to another discordant PCP. After adjustment and accounting for secular trends, the prevalence of glycemic control increased by 10% (95% CI, 2% to 17%; P = .01), poor glycemic control decreased by 4% (95% CI, -10% to 2%; P = .16) and LDL control increased by 9% (95% CI, 1% to 17%; P = .03). No significant changes were observed in SBP control. Prevalence of LDL control increased 15% (95% CI, 7% to 24%; P < .001) among LEP Latinos who switched from concordant to discordant PCPs. Risk factor control did not worsen following a PCP switch in any group. Conclusions and Relevance: We observed significant improvements in glycemic control among LEP Latino patients with diabetes who switched from language-discordant to concordant PCPs. Facilitating language-concordant care may be a strategy for diabetes management among LEP Latinos.

Multinight "bedside" closed-loop control for patients with type 1 diabetes.

BACKGROUND: Studies of closed-loop control (CLC) systems have improved glucose levels in patients with type 1 diabetes. In this study we test a new CLC concept aiming to "reset" the patient overnight to near-normoglycemia each morning, for several consecutive nights. SUBJECTS AND METHODS: Ten insulin pump users with type 1 diabetes (mean age, 46.4±8.5 years) were enrolled in a two-center (in the United States and Italy) randomized crossover trial comparing 5 consecutive nights of CLC (23:00-07:00 h) in an outpatient setting versus sensor-augmented insulin pump therapy of the same duration at home. Primary end points included time spent in 80-140 mg/dL as measured by continuous glucose monitoring overnight and fasting blood glucose distribution at 7:00 h. RESULTS: Compared with sensor-augmented pump therapy, CLC improved significantly time spent between 80 and 140 mg/dL (54.5% vs. 32.2%; P<0.001) and between 70 and 180 mg/dL (85.4% vs. 59.1%; P<0.001); CLC reduced the mean glucose level at 07:00 h (119.3 vs. 152.9 mg/dL; P<0.001) and overnight mean glucose level (139.0 vs. 170.3 mg/dL; P<0.001) using a marginally lower amount of insulin (6.1 vs. 6.8 units; P=0.1). Tighter overnight control led to improved daytime control on the next day: the overnight/next-day control correlation was r=0.52, P<0.01. CONCLUSIONS: Multinight CLC of insulin delivery (artificial pancreas) results in significant improvement in morning and overnight glucose levels and time in target range, with the potential to improve daytime control when glucose levels were "reset" to near-normoglycemia each morning.

Position statement on efficiency of technologies for diabetes management.

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality are of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring nd self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the directones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease.

Longitudinal study of new and prevalent use of self-monitoring of blood glucose.

OBJECTIVE: We sought to assess longitudinal association between self-monitoring of blood glucose (SMBG) and glycemic control in diabetic patients from an integrated health plan (Kaiser Permanente Northern California). RESEARCH DESIGN AND METHODS: Longitudinal analyses of glycemic control among 1) 16,091 patients initiating SMBG (new-user cohort) and 2) 15,347 ongoing users of SMBG (prevalent-user cohort). SMBG frequency was based on pharmacy use (number of blood glucose test strips dispensed), and glycemic control was based on HbA(1c) (A1C). In the new-user cohort, ANCOVA models (pre- and posttest design) were used to assess the effect of initiating SMBG. In the prevalent-user cohort, repeated-measure, mixed-effects models with random-intercept and time-dependent covariates were used to assess changes in SMBG and A1C. All models were stratified by therapy (no medications, oral agents only, or insulin) and adjusted for baseline A1C, sociodemographics, insulin injection frequency, comorbidity index, medication adherence, smoking status, health care use, and provider specialty. RESULTS: Greater SMBG practice frequency among new users was associated with a graded decrease in A1C (relative to nonusers) regardless of diabetes therapy (P < 0.0001). Changes in SMBG frequency among prevalent users were associated with an inverse graded change in A1C only among pharmacologically treated patients (P < 0.0001). CONCLUSIONS: These observational findings are consistent with short-term benefits of initiating SMBG practice for all patients but continuing benefits only for pharmacologically treated patients. Differences in effectiveness between new versus prevalent users of SMBG have implications for guideline development and interpretation of observational outcomes data.

Medication knowledge and self-management by people with type 2 diabetes.

OBJECTIVE: To explore medication knowledge and self-management practices of people with type 2 diabetes. DESIGN: A one-shot cross sectional study using in-depth interviews and participant observation. SETTING: Diabetes outpatient education centre of a university teaching hospital. SUBJECTS: People with type 2 diabetes, n=30, 17 males and 13 females, age range 33-84, from a range of ethnic groups. OUTCOME MEASURES: Ability to state name, main actions and when to take medicines. Performance of specific medication-related tasks; opening bottles and packs, breaking tablets in half, administering insulin, and testing blood glucose. RESULTS: Average medication use > or = 10years. Respondents were taking 86 different medicines, mean 7 +/- 2.97 SD. Dose frequency included two, three and four times per day. All respondents had > or = 2 diabetic complications +/- other comorbidities. The majority (93%) were informed about how and when to take their medicines, but only 37% were given information about side effects and 17% were given all possible seven items of information. Younger respondents received more information than older respondents. Older respondents had difficulty opening bottles and breaking tablets in half. Twenty percent regularly forgot to take their medicines. Increasing medication costs was one reason for stopping medicines or reducing the dose or dose interval. The majority tested their blood glucose but did not control test their meters and 33% placed used sharps directly into the rubbish. CONCLUSION: Polypharmacy was common. Medication knowledge and self-management were inadequate and could lead to adverse events.