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1.
J Med Internet Res ; 25: e45033, 2023 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-37606977

RESUMO

BACKGROUND: The prevalence of diabetes in the United States is high and increasing, and it is also the most expensive chronic condition in the United States. Self-monitoring of blood glucose or continuous glucose monitoring are potential solutions, but there are barriers to their use. Remote patient monitoring (RPM) with appropriate support has the potential to provide solutions. OBJECTIVE: We aim to investigate the adherence of Medicaid patients with diabetes to daily RPM protocols, the relationship between adherence and changes in blood glucose levels, and the impact of daily testing time on blood glucose changes. METHODS: This retrospective cohort study analyzed real-world data from an RPM company that provides services to Texas Medicaid patients with diabetes. Overall, 180 days of blood glucose data from an RPM company were collected to assess transmission rates and blood glucose changes, after the first 30 days of data were excluded due to startup effects. Patients were separated into adherent and nonadherent cohorts, where adherent patients transmitted data on at least 120 of the 150 days. z tests and t tests were performed to compare transmission rates and blood glucose changes between 2 cohorts. In addition, we analyzed blood glucose changes based on their testing time-between 1 AM and 10 AM, 10 AM and 6 PM, and 6 PM and 1 AM. RESULTS: Mean patient age was 70.5 (SD 11.8) years, with 66.8% (n=255) of them being female, 91.9% (n=351) urban, and 89% (n=340) from south Texas (n=382). The adherent cohort (n=186, 48.7%) had a mean transmission rate of 82.8% before the adherence call and 91.1% after. The nonadherent cohort (n=196, 51.3%) had a mean transmission rate of 45.9% before and 60.2% after. The mean blood glucose levels of the adherent cohort decreased by an average of 9 mg/dL (P=.002) over 5 months. We also found that variability of blood glucose level of the adherent cohort improved 3 mg/dL (P=.03) over the 5-month period. Both cohorts had the majority of their transmissions between 1 AM and 10 AM, with 70.5% and 53.2% for the adherent and nonadherent cohorts, respectively. The adherent cohort had decreasing mean blood glucose levels over 5 months, with the largest decrease during the 6 PM to 1 AM time period (30.9 mg/dL). Variability of blood glucose improved only for those tested from 10 AM to 6 PM, with improvements of 6.9 mg/dL (P=.02). Those in the nonadherent cohort did not report significant changes. CONCLUSIONS: RPM can help manage diabetes in Medicaid clients by improving adherence rates and glycemic control. Adherence calls helped improve adherence rates, but some patients still faced challenges in transmitting blood glucose levels. Nonetheless, RPM has the potential to reduce the risk of adverse outcomes associated with diabetes.


Assuntos
Glicemia , Diabetes Mellitus , Telemedicina , Idoso , Feminino , Humanos , Masculino , Automonitorização da Glicemia , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/terapia , Medicaid , Monitorização Fisiológica , Estudos Retrospectivos , Estados Unidos
2.
J Endocrinol Invest ; 45(9): 1663-1671, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35476320

RESUMO

PURPOSE: To evaluate if a web-based telemedicine system (the Glucoonline® system) is effective to improve glucose control in insulin-treated patients with type 1 and type 2 diabetes, as compared to standard of care. METHODS: This was a prospective, randomized, controlled trial, carried out at three tertiary referral centers for diabetes in Italy. Adults with insulin-treated type 1 and type 2 diabetes, inadequate glycemic control, and no severe diabetes-related complications and/or comorbidities were eligible for this study. Patients were randomized to either perform telemedicine-assisted (Group A) or standard (Group B) self-monitoring blood glucose (SMBG) for 6 months. In Group A, patients received prompt feedback about their blood glucose levels and therapy suggestions from the study staff via phone/SMS, when appropriate. In Group B, patients had no remote assistance from the study staff between planned visits. RESULTS: 123 patients were included in the final analysis. After 6 months, patients achieved a significant reduction in HbA1c in Group A (-0.38%, p < 0.05) but not in Group B (+ 0.08%, p = 0.53). A significant difference in the percentage of patients with HbA1c < 7% between Group A and Group B was found after 3 months (28.6% vs 11.1%, p = 0.02). Also, fewer patients (p < 0.05) with HbA1c > 8.5% were found in Group A vs Group B, respectively, after both 3 months (14.3% vs 35.2%) and 6 months (21.8% vs 42.9%). CONCLUSIONS: The use of the Glucoonline™ system resulted in improved metabolic control. Telemedicine services have potential to support diabetes self-management and provide the patients with remote, prompt assistance using affordable technological equipment. Trial registration This study was registered at clinicaltrials.gov (NCT01804803) on March 5, 2013.


Assuntos
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Telemedicina , Adulto , Glicemia/análise , Automonitorização da Glicemia/métodos , Diamante , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Estudos Prospectivos , Telemedicina/métodos
3.
Sensors (Basel) ; 22(16)2022 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-36015970

RESUMO

Background: Self-monitoring of blood glucose (SMBG) is of paramount relevance for type 2 diabetes mellitus (T2DM) patients. However, past evidence shows that there are physical and cognitive issues that might limit the usage of glucometers by T2DM patients aged 65 years and over. Objective: Our aim was to investigate the physical and cognitive issues related to the usage of glucometers by T2DM patients aged 65 years and over. Materials and Methods: The extant literature was analysed to define an original framework showing the logical nexus between physical and cognitive issues and quality of life. Then we collected evidence addressing the specific case of the Accu-Chek® Instant glucometer produced by Roche Diabetes Care GmbH, which implements new features claiming to improve usability. We conducted 30 interviews with T2DM patients aged 65 years and over, three interviews with senior nurses, and a focus group with three senior physicians and three senior nurses. Results: From the interviews, both patients and nurses declared that they were generally satisfied with the Accu-Chek® Instant glucometer's characteristics. In the focus group, the results were commented on and, in the light of some diverging answers, improvements have been set up for future implementation. Conclusions: Our study produces evidence and future suggestions about the usage of glucometers by type 2 diabetes patients aged 65 years and over.


Assuntos
Automonitorização da Glicemia , Diabetes Mellitus Tipo 2 , Idoso , Glicemia , Automonitorização da Glicemia/instrumentação , Cognição , Humanos , Qualidade de Vida
4.
Diabetes Obes Metab ; 23(11): 2521-2528, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34286892

RESUMO

AIMS: Most people living with type 1 diabetes self-manage using multiple daily injection (MDI) insulin regimens and self-monitoring of blood glucose (SMBG). Continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) are adjuncts to education and support self-management optimization. The aim of this systematic review and meta-analysis was to assess which first-line technology is most effective. METHODS: Electronic databases (MEDLINE, EMBASE and WEB OF SCIENCE) were systematically searched from 1999 to September 2020. Randomized controlled trials comparing either CSII with MDI or CGM with SMBG in adults with type 1 diabetes were included. Data were extracted in duplicate by two reviewers, and were analysed to assess individual and overall treatment effect measures (PROSPERO registration: CRD42020149915). RESULTS: Glycated haemoglobin was significantly reduced for CGM when compared with SMBG [Cohen's d - 0.62 (95% CI -0.79 to -0.45)] and for CSII when compared with MDI [Cohen's d - 0.44 (95% CI -0.67 to -0.22)]. Rates of severe hypoglycaemia were significantly reduced with CGM compared with SMBG, but did not change for CSII when compared with MDI. Episodes of diabetic ketoacidosis were more likely to occur with CSII than MDI. Both CSII and CGM reduced glucose standard deviation, compared with MDI and SMBG respectively. CONCLUSIONS: Both CGM and CSII remain impactful interventions compared with SMBG and MDI but in adults with type 1 diabetes and in the contexts in which they have been studied, CGM might have a greater positive impact on glycaemic variability and severe hypoglycaemia than CSII, when added to MDI and SMBG. A head-to-head study, including patient reported outcomes, is required to explore these findings further.


Assuntos
Diabetes Mellitus Tipo 1 , Adulto , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêutico , Injeções Subcutâneas , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Avaliação de Resultados em Cuidados de Saúde
5.
Cardiovasc Diabetol ; 18(1): 10, 2019 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-30691463

RESUMO

Novel studies have increased our knowledge regarding optimal treatment options in diabetes. Key studies that have broadened our knowledge about optimal treatment options in diabetes in recent years are cardiovascular outcome trials (CVOTs) and studies investigating aspects of digitalisation and monitoring of glucose (e.g. PDM-ProValue). We aimed at highlighting similarities between the two important pillars for a successful diabetes management. We emphasise the need for a consideration of both approaches in future clinical trial designs and protocols.


Assuntos
Automonitorização da Glicemia , Glicemia/metabolismo , Doenças Cardiovasculares/prevenção & controle , Ensaios Clínicos como Assunto/métodos , Diabetes Mellitus/terapia , Projetos de Pesquisa , Idoso , Biomarcadores/sangue , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus/sangue , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiologia , Determinação de Ponto Final , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , Resultado do Tratamento
6.
P T ; 44(9): 554-559, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31485151

RESUMO

Self-monitoring of bood glucose alone is not a good predictor of HbA1c goal attainment. Health plans might benefit from formulary restrictions to provide more cost-effective care, without negatively impacting glycemic control. And by using targeted inteventions, healthcare providers could help maximize SMBG's clinical benefit for patients who receive test strips. Self-monitoring of blood glucose (SMBG) can be an important tool in diabetes treatment, both for patient self-management and for guiding clinicians regarding medication adjustments. Evidence supports the association of SMBG with clinical outcomes in patients with type-1 diabetes mellitus (T1DM) although it is mixed for patients with type-2 diabetes mellitus (T2DM). The cost of SMBG comprises a substantial portion of the total cost for patients with diabetes, and test strips are one of the main expenditures of the University of North Carolina Medical Center Pharmacy Assistance Program (PAP), which provides medication coverage, including test strips, to indigent patients who have no pharmacy insurance. The objective of this study is to evaluate the utility of SMBG based on the impact of test-strip adherence on glycemic goal attainment in an indigent population that is provided with low-copay test strips. This retrospective cohort study included patients with T1DM or T2DM who were enrolled in PAP in 2016 and who received a prescription for test strips during the 90 days prior to hemoglobin A1c (HbA1c) measurement. Adherence was defined as the proportion of days covered (PDC) > 0.8. Of the 498 patients encountered, 20% of the adherent group (n = 245) and 25% of the nonadherent group (n = 253) had a goal of HbA1c < 7% (P = 0.24). There were no differences in mean HbA1c between the groups, except in the multiple daily injections (MDI) of the insulin subgroup (8.9% vs. 9.6%, P = 0.009). The adherent group was 80% less likely to have a diabetes-related hospitalization (odds ratio [OR], 0.2; 95% CI, 0.04-0.92). The total test-strip cost to PAP was more than $200,000. In conclusion, in an indigent population, adherence to SMBG does not correlate with glycemic goal attainment and imposes a substantial cost burden on the healthcare system.

7.
Ann Fam Med ; 16(4): 349-352, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29987085

RESUMO

This qualitative study examines to what extent and why physicans still prescribe self-monitoring of blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes (NITT2D) when the evidence shows it increases cost without improving hemoglobin A1c (HbA1c), general well being, or health-related quality of life. Semistructured phone interviews with 17 primary care physicians indicated that the majority continue to recommend routine self-monitoring of blood glucose due to a compelling belief in its ability to promote the lifestyle changes needed for glycemic control. Targeting physician beliefs about the effectiveness of self-monitoring of blood glucose, and designing robust interventions accordingly, may help reduce this practice.


Assuntos
Atitude do Pessoal de Saúde , Automonitorização da Glicemia , Diabetes Mellitus Tipo 2/sangue , Relações Médico-Paciente , Médicos de Atenção Primária , Diabetes Mellitus Tipo 2/reabilitação , Feminino , Hemoglobinas Glicadas/análise , Humanos , Entrevistas como Assunto , Estilo de Vida , Masculino , Educação de Pacientes como Assunto , Segurança do Paciente , Pesquisa Qualitativa , Autocuidado
8.
Saudi Pharm J ; 26(7): 965-969, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30416354

RESUMO

BACKGROUND: Patients with uncontrolled type 1 diabetes mellitus (T1DM) are at a high risk for Ramadan fasting and are exempt from fasting; however, most still insist on fasting. The aim of this study was to examine glucose level fluctuations in those patients during Ramadan fasting using a real-time continuous glucose monitoring system (RT-CGMS). METHODS: This pilot study involved adult patients with uncontrolled T1DM (HbA1c > 7%) who insisted on fasting during Ramadan in 2014 from Maternity and Children's Hospital, Medina, Saudi Arabia. A Medtronic RT-CGMS was used to monitor the participants' glucose levels for 3 consecutive days during fasting. RESULTS: The study included 22 patients (mean age 22 ±â€¯6 years, duration of diabetes 10.9 ±â€¯7.2 years, HbA1c level 9.3 ±â€¯1.2). All participants were using the basal-bolus insulin regimen, except for one patient who was on an insulin pump. Sensor glucose (SG) profiles typically followed a pattern that was characterized by an exaggerated increase after iftar, which was sustained overnight, and a second rapid rise after suhoor, with a prolonged glucose decay over the daylight hours. The average SG was 199 ±â€¯104.1 mg/dl, which was lower during fasting 188.4 ±â€¯103.41 mg/dl than during the eating hours 212.5 ±â€¯103.51 mg/dl (P = 0.00). There was a higher rate of hyperglycemia (48%) than hypoglycemia (10%). CONCLUSIONS: Patients with uncontrolled T1DM who fasted during Ramadan experienced a wide fluctuation of glucose levels between fasting and eating hours, exhibiting a greater tendency toward hyperglycemia. The long-term effects for this finding are not known and warrant further investigation.

9.
BMC Endocr Disord ; 17(1): 4, 2017 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-28143495

RESUMO

BACKGROUND: The benefit of Self-monitoring of Blood Glucose (SMBG) in people with non-insulin treated type 2 diabetes remains unclear with inconsistent evidence from randomised controlled trials fuelling the continued debate. Lack of a consistent finding has been attributed to variations in study population and design, including the SMBG intervention. There is a growing consensus that structured SMBG, whereby the person with diabetes and health care provider are educated to detect patterns of glycaemic abnormality and take appropriate action according to the blood glucose profiles, can prove beneficial in terms of lowering HbA1c and improving overall well-being. Despite this, many national health agencies continue to issue guidelines restricting the use of SMBG in non-insulin treated type 2 diabetes. METHODS: The SMBG Study is a 12 month, multi-centre, randomised controlled trial in people with type 2 diabetes not on insulin therapy who have poor glycaemic control (HbA1c ≥58 mmol/mol / 7.5%). The participants will be randomised into three comparative groups: Group 1 will act as a control group and receive their usual diabetes care; Group 2 will undertake structured SMBG with clinical review every 3 months; Group 3 will undertake structured SMBG with additional monthly telecare support from a trained study nurse. A total of 450 participants will be recruited from 16 primary and secondary care sites across Wales and England. The primary outcome measure will be HbA1c at 12 months with secondary measures to include weight, BMI, total cholesterol and HbA1c levels at 3, 6, 9 and 12 months. Participant well-being and attitude towards SMBG will be monitored throughout the course of the study. Recruitment began in December 2012 with the last participant visit due in September 2016. DISCUSSION: This study will attempt to answer the question of whether structured SMBG provides any benefits to people with poorly controlled type 2 diabetes who are not being treated with insulin. The data will also clarify whether the telecare support provides additional value. The overall acceptability of SMBG as a tool for self-management will be assessed. TRIAL REGISTRATION: UKCRN 12038 (Registered March 2012). ISRCTN21390608 (Retrospectively registered 15th May 2014).


Assuntos
Automonitorização da Glicemia/métodos , Glicemia/análise , Protocolos Clínicos/normas , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Adolescente , Adulto , Idoso , Biomarcadores/análise , Feminino , Seguimentos , Hemoglobinas Glicadas/análise , Humanos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica , Prognóstico , Inquéritos e Questionários , Adulto Jovem
10.
J Endocrinol Invest ; 40(7): 741-744, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28239763

RESUMO

BACKGROUND: Even though patients with type 1 diabetes mellitus (T1DM) are exempted from fasting, the vast majority elect to fast against the advice of their healthcare providers. We have previously reported the incidence of wide fluctuations in blood glucose (BG) along with "unrecognized" severe hypoglycemia during Ramadan fasting in adolescents with T1DM. This report compares the continuous glucose monitoring (CGM) data during fasting in adolescents with T1DM according to their Pre-Ramadan diabetes control. METHODS: Children and adolescents with T1DM who intended to fast the month of Ramadan were asked to wear the CGM during fasting for a minimum of 3 days. Hypoglycemia, hyperglycemia, and severe hyperglycemia were identified as BG <70 mg/dL (3.9 mmol/L), BG 201-300 mg/dL (11.2-16.7 mmol/L), or BG >300 mg/dL (16.7 mmol/L) respectively, while normoglycemia was identified as BG 70-200 mg/dL (3.9-11.1 mmol/L). Patients were categorized as well-controlled (Group 1) and poorly controlled (Group 2) if the pre-fasting HbA1C was ≤8% (64 mmol/mol) and >8%, respectively. We compared the mean BG and the percentages of time spent in hypoglycemia, hyperglycemia, and severe hyperglycemia between the two groups using Chi-square (significant difference when P value was <0.05). RESULTS: A total of 21 patients were enrolled (15 females), age 15 ± 4 years, duration of diabetes 6 ± 3 years, and HbA1C 8.5 ± 1.0% (70 mmol/mol). There were 7 subjects in Group 1, mean HbA1C 7.5 ± 0.4, and 14 subjects in Group 2, mean HbA1C 9.1 ± 0.9. The mean ± SD BG was 174 ± 76 mg/dL versus 199 ± 98, (P < 0.05) in Group 1 and Group 2, respectively. The percentages of hypoglycemia, hyperglycemia, and severe hyperglycemia were significantly higher in Group 2, while there was a higher percentage of normoglycemia in Group 1. The overall durations of hypoglycemia, hyperglycemia, and severe hyperglycemia in Group 2 were longer by 30, 14, and 135%, respectively, than those in Group 1. CONCLUSIONS: Glycemic control before Ramadan in adolescents with T1 DM appears to correlate with blood glucose profile during Ramadan fasting. Our data suggest that optimal glycemic control before Ramadan may reduce the potential risks associated with fasting and minimize glucose fluctuation.


Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 1/fisiopatologia , Jejum/fisiologia , Hiperglicemia/epidemiologia , Hipoglicemia/epidemiologia , Hipoglicemiantes/administração & dosagem , Islamismo , Adolescente , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Hemoglobinas Glicadas/análise , Humanos , Hiperglicemia/induzido quimicamente , Hipoglicemia/induzido quimicamente , Masculino , Prevalência , Emirados Árabes Unidos/epidemiologia
11.
BMC Health Serv Res ; 17(1): 369, 2017 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-28545493

RESUMO

BACKGROUND: For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting. METHODS/DESIGN: Using stakeholder engagement approach, we developed and implemented a pragmatic trial of patient with non-insulin treated T2DM patients from five primary care practices randomized to one of three SMBG regimens: 1) no testing; 2) once daily testing with standard feedback consisting of glucose values being immediately reported to the patient through the glucose meter; and 3) once daily testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient PLUS automated, tailored feedback messaging delivered to the patient through the glucose meter following each testing. Main outcomes assessed at 52 weeks include quality of life and glycemic control. DISCUSSION: This pragmatic trial seeks to better understand the value of SMBG in non-insulin treated patients with T2DM. This paper outlines the protocol used to implement this study in fifteen community-based primary care practices and highlights the impact of stakeholder involvement from the earliest stages of project conception and implementation. Plans for stakeholder involvement for result dissemination are also discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02033499 , January 9, 2014.


Assuntos
Automonitorização da Glicemia/métodos , Glicemia/análise , Diabetes Mellitus Tipo 2/sangue , Hemoglobinas Glicadas/análise , Automonitorização da Glicemia/instrumentação , Protocolos Clínicos , Feminino , Humanos , Hipoglicemia/diagnóstico , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados da Assistência ao Paciente , Qualidade de Vida , Projetos de Pesquisa
12.
J Med Internet Res ; 19(7): e234, 2017 07 11.
Artigo em Inglês | MEDLINE | ID: mdl-28698167

RESUMO

BACKGROUND: The Livongo for Diabetes Program offers members (1) a cellular technology-enabled, two-way messaging device that measures blood glucose (BG), centrally stores the glucose data, and delivers messages back to the individual in real time; (2) unlimited BG test strips; and (3) access to a diabetes coaching team for questions, goal setting, and automated support for abnormal glucose excursions. The program is sponsored by at-risk self-insured employers, health plans and provider organizations where it is free to members with diabetes or it is available directly to the person with diabetes where they cover the cost. OBJECTIVE: The objective of our study was to evaluate BG data from 4544 individuals with diabetes who were enrolled in the Livongo program from October 2014 through December 2015. METHODS: Members used the Livongo glucose meter to measure their BG levels an average of 1.8 times per day. We estimated the probability of having a day with a BG reading outside of the normal range (70-180 mg/dL, or 3.9-10.0 mmol/L) in months 2 to 12 compared with month 1 of the program, using individual fixed effects to control for individual characteristics. RESULTS: Livongo members experienced an average 18.4% decrease in the likelihood of having a day with hypoglycemia (BG <70 mg/dL) and an average 16.4% decrease in hyperglycemia (BG >180 mg/dL) in months 2-12 compared with month 1 as the baseline. The biggest impact was seen on hyperglycemia for nonusers of insulin. We do not know all of the contributing factors such as medication or other treatment changes during the study period. CONCLUSIONS: These findings suggest that access to a connected glucose meter and certified diabetes educator coaching is associated with a decrease in the likelihood of abnormal glucose excursions, which can lead to diabetes-related health care savings.


Assuntos
Automonitorização da Glicemia/métodos , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/terapia , Insulina/uso terapêutico , Autocuidado/métodos , Adolescente , Adulto , Idoso , Diabetes Mellitus Tipo 2/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
13.
BMC Endocr Disord ; 16(1): 21, 2016 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-27145817

RESUMO

BACKGROUND: Safe and effective insulin therapy for diabetes mellitus requires initial dose titration and regular adjustments based on blood glucose (BG) monitoring. Our objective was to explore the use of BG measurement in phase-III clinical studies of insulin analogs. These studies provide safety and efficacy information for regulatory authorities and are the basis for insulin analog regulatory approval. METHODS: A systematic review of phase-III studies of rapid-acting insulin analogs (insulin lispro, insulin aspart and insulin glulisine) and pre-mixed insulin analogs (biphasic insulin aspart and insulin lispro mix) was conducted. Studies were identified using manufacturers' databases. Search for reports was performed in Medline and registry of clinical trials (clinicaltrials.gov). The European Medicines Agency was contacted to provide Clinical Study Reports. RESULTS: Forty-five studies were included. Regular BG measurements were reported in 100 % of the studies and were performed by either self-monitoring of blood glucose (SMBG) alone in 84 %, laboratory alone in 7 %, and both SMBG and laboratory in 9 % of studies. In total, 93 % of the studies reported SMBG. Most studies (91 %) reported insulin therapy adjustments based on BG measurements. CONCLUSIONS: The findings suggest that BG monitoring and specifically SMBG are co-dependent technologies with insulin analogs. BG measurement is used in most phase-III registration studies for establishing safe and efficacious insulin administration and is recommended in the insulin labels. The indispensable role of SMBG in treatment of insulin-dependent patients should receive attention from health care payers to assess and reimburse SMBG along with insulin to avoid adverse events from inappropriate insulin administration and associated costs.


Assuntos
Automonitorização da Glicemia , Glicemia , Ensaios Clínicos Fase III como Assunto , Diabetes Mellitus/tratamento farmacológico , Insulinas/uso terapêutico , Feminino , Humanos , Insulinas/administração & dosagem , Insulinas/efeitos adversos , Masculino
14.
Diabetes Metab Res Rev ; 31(1): 61-8, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24816997

RESUMO

BACKGROUND: The aim of this study was to determine the efficacy of real-time continuous glucose monitoring in T1D patients treated with insulin pump therapy or multiple daily insulin therapy. METHODS: Twenty adult patients (ten insulin pump therapy and ten multiple daily insulin) with poor glycaemic control (HbA1c > 8.0%) were randomized into two groups for 6 months: the continuous glucose monitoring arm (using real-time continuous glucose monitoring) and the SMBG arm. After 2 months of wash-out, the participants crossed over. The primary outcome was HbA1c reduction. The secondary outcomes were hypoglycaemia and hyperglycaemia risk assessment (area under the curve < 70 mg/dL/day and AUC > 200 mg/dL/day, respectively) and glucose variability. RESULTS: Fourteen patients (eight multiple daily insulin, six insulin pump therapy) used continuous glucose monitoring appropriately (at least 40% of the time). In these patients, the improvement in glycaemic control was more evident during the real-time continuous glucose monitoring period (7.76% ± 0.4 vs 8.54% ± 0.4, p < 0.05) than during the self-monitoring of blood glucose period (8.42% ± 0.4 vs 8.56% ± 0.5, p = 0.2). Better results with continuous glucose monitoring were observed in patients using multiple daily insulin with greater improvement in both glycaemic control (7.71% ± 0.2 vs 8.58% ± 0.2, p < 0.05) and glucose variability and with a marked reduction in the risk of both hypoglycaemia and hyperglycaemia. CONCLUSIONS: Appropriate use of real-time continuous glucose monitoring improved glycometabolic control in T1D patients. The effects of continuous glucose monitoring were more evident in patients under multiple daily insulin treatment, compared with insulin pump therapy. Glucose variability, in addition to glycaemic control, was improved in compliant diabetic patients.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Insulina/administração & dosagem , Adolescente , Adulto , Glicemia/metabolismo , Automonitorização da Glicemia/métodos , Estudos Cross-Over , Feminino , Humanos , Injeções Subcutâneas , Insulina/efeitos adversos , Sistemas de Infusão de Insulina , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
15.
Pediatr Diabetes ; 16(5): 354-60, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25039921

RESUMO

OBJECTIVE: To investigate the prevalence of severe hypoglycemia in Danish children and adolescents with type 1 diabetes and to pinpoint predictors of this acute complication in children on modern treatment modalities. RESEARCH DESIGN AND METHODS: The study is based on data from DanDiabKids, a national diabetes register for children and adolescents. The register contains data on patients with type 1 diabetes with an ascertainment rate of 99%. Data from 3320 patients aged 0-18 yr was included in the study period from 1998 to 2009 and analyzed using a negative binomial model. RESULTS: One thousand nine hundred and ninety-nine episodes of severe hypoglycemia in 867 patients were registered conferring an overall incidence of severe hypoglycemia of 15.1 [95% confident interval (CI): 13.8; 16.4] per 100 patient years. This remained unchanged during the study period. Duration of diabetes, age and treatment in centers managing less than 100 patients significantly increased the risk of severe hypoglycemia (p < 0.001). Patients on insulin pump therapy had a 42% reduced risk of severe hypoglycemia compared with pen treated patients (p = 0.01). Patients treated with five or more daily insulin injections had a 31% (95% CI: 17; 49) reduced risk of severe hypoglycemia compared to patients on fewer daily injections (p = 0.015). CONCLUSIONS: Despite improvements in metabolic control over a decade the prevalence of severe hypoglycemic events remained unchanged. More intensive treatments such as insulin pump therapy and multiple daily injections on a national level seems to be a protective factor for developing severe hypoglycemia up to 2009.


Assuntos
Diabetes Mellitus Tipo 1/epidemiologia , Hipoglicemia/diagnóstico , Hipoglicemia/epidemiologia , Adolescente , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Lactente , Recém-Nascido , Masculino , Prevalência , Prognóstico , Fatores de Risco , Índice de Gravidade de Doença
16.
J Pak Med Assoc ; 65(12): 1360-2, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26627526

RESUMO

Ambulatory glucose profile (AGP) is a novel way of assessing glycaemic levels on a 24 hour basis, through a minimally invasive method, known as flash glucose monitoring. This review describes the unique features of AGP, differentiates it from existing methods of glucose monitoring, and explains how it helps pursue the glycaemic pentad. The review suggests pragmatic usage of this technology, including pre-test, intra-test, and post-test counselling, and lists specific clinical scenarios where the investigation seems to be of immense benefit.


Assuntos
Automonitorização da Glicemia/instrumentação , Transtornos do Metabolismo de Glucose/diagnóstico , Humanos
17.
J Pak Med Assoc ; 65(5 Suppl 1): S51-3, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-26013788

RESUMO

In patients with diabetes who intend to fast during Ramadan, self-monitoring of blood glucose (SMBG) is an important tool. During this month, a long established treatment regimen, including medications, physical activity and diet plan, is changed to achieve concordance with the rules of fasting. Without proper glucose monitoring, it is not possible to achieve good glycaemic control.

18.
Diabetes Res Clin Pract ; 209: 111027, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38000665

RESUMO

AIM: To determine the association between the frequency of self-monitoring of blood glucose (SMBG) and glycemic control in patients with type 2 diabetes. METHODS: The retrospective study analyzed data from 3,630 patients with type 2 diabetes who were enrolled between August 2020 and July 2021. 2456 non-insulin-treated patients were divided into SMBG ≤ 6 times/week and > 6 times/week groups. 1174 insulin-treated patients were divided into SMBG ≤ 9 times/week and > 9 times/week groups. Propensity score matching was used to generate groups with well-balanced covariates. Primary outcomes were changes in fasting blood glucose (FBG) and postprandial blood glucose (PBG) from baseline to 6 months. RESULTS: In the non-insulin-treated group, a comparison in FBG and PBG reduction between the SMBG > 6 times/week and ≤ 6 times/week groups was statistically significant (-0.59 vs. -0.18 mmol/l, P < 0.001; -0.91 vs. -0.36 mmol/l, P < 0.001). In the insulin-treated group, there was no statistically significant reduction in FBG or PBG, patients with baseline FBG > 8 or 9 mmol/l and SMBG > 9 times/week had a significant FBG reduction than the ≤ 9 times/week group. CONCLUSION: Frequent SMBG was associated with better glycemic control in non-insulin-treated patients. Insulin-treated patients with poor glycemic control may benefit from frequent SMBG.


Assuntos
Diabetes Mellitus Tipo 2 , Humanos , Glicemia , Controle Glicêmico , Estudos Retrospectivos , Insulina/uso terapêutico , Automonitorização da Glicemia , Insulina Regular Humana , Hipoglicemiantes/uso terapêutico
19.
Cureus ; 16(1): e51496, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38304693

RESUMO

Objectives We aimed to determine the benefits and drawbacks of real-time continuous glucose monitoring (rtCGM) compared with those of self-monitoring of blood glucose (SMBG) in children and adolescents with type 1 diabetes (T1D) and their impact on glycemic control, hypo- and hyperglycemic episodes, exercise, quality of life, and psychosocial factors. Methodology This quantitative, comparative, cross-sectional study was conducted between July 2022 and March 2023 at the Pediatric Endocrine Outpatient Clinic, King Abdulaziz University Hospital, Saudi Arabia. Data were obtained via a clinical interview with children and adolescents with T1D aged 2-18 years. Results The study involved 121 participants, with 71 (58.7%) male patients and 50 (41.3%) female patients. The participants' mean age was 11.9 ± 4.4 years. Compared with patients using SMBG, patients using rtCGM demonstrated a more significant decrease in the mean glycated hemoglobin (HbA1c) level from baseline (7.79 ± 1.17 vs. 8.92 ± 1.63, P = 0.001), a reduction in the number of hypoglycemic episodes (85.7% vs. 70.6%, P = 0.028), and stable blood glucose level during exercise (97.2% vs. 76.4%, P = 0.001). Additionally, 65 (92.9%) rtCGM users had undisturbed sleep compared with 22 (43.1%) SMBG users. Approximately 64 (91.4%) rtCGM users reported that the sensor helped decrease their anxiety levels and pain sensations. Conclusions In this novel study in Saudi Arabia, rtCGM demonstrated a significantly better impact than SMBG on glycemic control, hypo- and hyperglycemic episodes, and psychosocial factors in children and adolescents with T1D.

20.
Diabetes Technol Ther ; 26(2): 103-111, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38032852

RESUMO

Objective: To establish an accurate and robust calculation model for predicting hemoglobin A1c (HbA1c) for people with type 2 diabetes (T2D) by using the fewest discrete blood glucose values according to an irregular data set and propose an appropriate cost-effective and scientific scheme for routine blood glucose monitoring. Methods: By using two data sets obtained from 2017 to 2022, which involved 2432 people with T2D, ∼420,000 irregular blood glucose values, and 10,000 HbA1c values, multiple blood glucose monitoring schemes were designed and compared to find the optimal one. The data were structured and then fitted using a regularized extreme learning machine, and the results were evaluated on the basis of indicators such as mean absolute error (MAE), root mean square error, and the relevance analysis (R) value; the optimal scheme for routine blood glucose monitoring was determined by combining the accuracy and the cost and was compared with previous studies in terms of accuracy and stability. Results: Data fitting results for the chosen scheme: R = 0.8029 (P < 0.001), MAE = 0.3181% (95% confidence interval, 0.2666-0.3695%). Within the last 4 weeks before the prediction of HbA1c, a minimum of only seven fasting and seven postprandial blood glucose values are needed, of which are one fasting and one postprandial blood glucose values per 4 days. Compared with previous studies, the prediction model shows better accuracy and stability (P < 0.05), especially under the great glucose fluctuation group. Conclusion: A minimized calculation model for accurately and robustly predicting HbA1c using discrete self-monitoring of blood glucose data within 4 weeks for people with T2D has been established and provides a new reference for the design of a scheme for blood glucose monitoring. The diabetes care clinic of Peking University First Hospital (Registration Number: ChiCTR2300068139).


Assuntos
Glicemia , Diabetes Mellitus Tipo 2 , Humanos , Hemoglobinas Glicadas , Automonitorização da Glicemia/métodos , Jejum
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