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AIMS: This real-world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180-day Eversense CGM System (Eversense) in patients with type 1 diabetes. MATERIALS AND METHODS: This was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes-care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70-180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery. RESULTS: One-hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty-six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (-0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM-naïve patients achieved the greatest reduction in HbA1c (-0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear. CONCLUSIONS: Real-world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).
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Diabetes Mellitus Tipo 1 , Adolescente , Adulto , Glucemia , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hemoglobina Glucada/análisis , Humanos , Insulina , Italia , Persona de Mediana Edad , Estudios Prospectivos , Adulto JovenRESUMEN
OBJECTIVE: Fasting C-peptide levels are used to differentiate type 1 from type 2 diabetes (T2D), thereby determining eligibility for coverage of continuous subcutaneous insulin infusion (CSII) for patients with T2D. METHODS: A total of 168 patients (74 female/94 male, aged 55.5 ± 9.7 years) were randomized to CSII, and 163 patients (77 female/86 male, aged 56.4 ± 9.5 years) were randomized to multiple daily injections (MDI) of insulin and grouped by baseline C-peptide level: group A (≤183 pmol/L [≤0.55 ng/mL]); group B (>183 pmol/L [>0.55 ng/mL]). At 6 months, the MDI group crossed over to CSII. Within- and between-group comparisons were recorded at 6 and 12 months in the entire group and separately for those patients aged ≥65 years. RESULTS: CSII reduced hemoglobin A1c (A1c) equally in groups A ( P = .0006, P = .0022) and B ( P<.0001, P<.0001) at 6 and 12 months, respectively. There was an increase in weight in group A versus group B at 6 months but not 12 months ( P<.03). CSII therapy reduced total daily dose (TDD) of insulin and improved treatment satisfaction similarly in groups A and B. The results for patients aged ≥65 years displayed a similar trend as the entire group. CONCLUSION: A1c, TDD of insulin, and treatment satisfaction improved for T2D patients using CSII versus MDI therapy, irrespective of baseline C-peptide level. A subgroup of patients aged ≥65 years displayed a similar trend. These results support abandoning C-peptide as a criterion for reimbursing CSII therapy in patients with diabetes. ABBREVIATIONS: A1c = hemoglobin A1c; CMS = Centers for Medicare and Medicaid Services; CSII = continuous subcutaneous insulin infusion; DTSQ = Diabetes Treatment Satisfaction Questionnaire; MDI = multiple daily injections; RCT = randomized controlled trials; T1D = type 1 diabetes; T2D = type 2 diabetes; TDD = total daily dose.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Satisfacción del Paciente , Adulto , Anciano , Glucemia/metabolismo , Péptido C/metabolismo , Diabetes Mellitus Tipo 2/metabolismo , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemia/inducido químicamente , Inyecciones Subcutáneas , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: The threshold-suspend feature of sensor-augmented insulin pumps is designed to minimize the risk of hypoglycemia by interrupting insulin delivery at a preset sensor glucose value. We evaluated sensor-augmented insulin-pump therapy with and without the threshold-suspend feature in patients with nocturnal hypoglycemia. METHODS: We randomly assigned patients with type 1 diabetes and documented nocturnal hypoglycemia to receive sensor-augmented insulin-pump therapy with or without the threshold-suspend feature for 3 months. The primary safety outcome was the change in the glycated hemoglobin level. The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events. Two-hour threshold-suspend events were analyzed with respect to subsequent sensor glucose values. RESULTS: A total of 247 patients were randomly assigned to receive sensor-augmented insulin-pump therapy with the threshold-suspend feature (threshold-suspend group, 121 patients) or standard sensor-augmented insulin-pump therapy (control group, 126 patients). The changes in glycated hemoglobin values were similar in the two groups. The mean AUC for nocturnal hypoglycemic events was 37.5% lower in the threshold-suspend group than in the control group (980 ± 1200 mg per deciliter [54.4 ± 66.6 mmol per liter] × minutes vs. 1568 ± 1995 mg per deciliter [87.0 ± 110.7 mmol per liter] × minutes, P<0.001). Nocturnal hypoglycemic events occurred 31.8% less frequently in the threshold-suspend group than in the control group (1.5 ± 1.0 vs. 2.2 ± 1.3 per patient-week, P<0.001). The percentages of nocturnal sensor glucose values of less than 50 mg per deciliter (2.8 mmol per liter), 50 to less than 60 mg per deciliter (3.3 mmol per liter), and 60 to less than 70 mg per deciliter (3.9 mmol per liter) were significantly reduced in the threshold-suspend group (P<0.001 for each range). After 1438 instances at night in which the pump was stopped for 2 hours, the mean sensor glucose value was 92.6 ± 40.7 mg per deciliter (5.1 ± 2.3 mmol per liter). Four patients (all in the control group) had a severe hypoglycemic event; no patients had diabetic ketoacidosis. CONCLUSIONS: This study showed that over a 3-month period the use of sensor-augmented insulin-pump therapy with the threshold-suspend feature reduced nocturnal hypoglycemia, without increasing glycated hemoglobin values. (Funded by Medtronic MiniMed; ASPIRE ClinicalTrials.gov number, NCT01497938.).
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Adolescente , Adulto , Anciano , Área Bajo la Curva , Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Sistemas de Infusión de Insulina/efectos adversos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
Background: Use of continuous glucose monitoring (CGM) systems is being rapidly adopted as standard of care for insulin-requiring patients with diabetes. The PROMISE study (NCT03808376) evaluated the accuracy and safety of the next-generation implantable Eversense CGM system for up to 180 days. Methods: This was a prospective multicenter study involving 181 subjects with diabetes at 8 USA sites. All subjects were inserted with a primary sensor. Ninety-six subjects had a second sensor, either an identical sensor or a modified sensor (sacrificial boronic acid [SBA]), inserted in their other arm (53 and 43 subjects, respectively). Accuracy was evaluated by comparing CGM to YSI 2300 glucose analyzer (Yellow Springs Instrument [YSI]) values during 10 clinic visits (day 1-180). Confirmed event detection rates, calibration stability, sensor survival, and serious adverse events (SAEs) were evaluated. Results: For primary sensors, the percent CGM readings within 20%/20% of YSI values was 92.9%; overall mean absolute relative difference (MARD) was 9.1%. The confirmed alert detection rate at 70 mg/dL was 93% and at 180 mg/dL was 99%. The median percentage of time for one calibration per day was 56%. Sixty-five percent of the primary sensors survived to 180 days. For the SBA sensors, the percent CGM readings within 20%/20% of YSI values was 93.9%; overall MARD was 8.5%. The confirmed alert detection rate at 70 mg/dL was 94% and at 180 mg/dL was 99%. The median percentage of time for one calibration per day was 63%. Ninety percent of the SBA sensors survived to 180 days. No device- or insertion/removal procedure-related SAEs were reported. Conclusion: These data show the next-generation Eversense CGM system had sustained accuracy and safety up to 180 days, with an improved calibration scheme and survival, using the primary or SBA sensors.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Glucemia , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Humanos , Estudios Prospectivos , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: Type 1 diabetes and dyslipidemia are known risk factors for cardiovascular disease (CVD), but the relationship between lipid levels in youth with type 1 diabetes and future CVD remains unknown. OBJECTIVE: To characterize lipid levels and CVD risk factors over time in youth with type 1 diabetes. SUBJECTS: The study included adolescents with type 1 diabetes (12-25 yr) with a minimum of 3-yr follow-up. METHODS: A longitudinal prospective, observational study of 46 youth with type 1 diabetes was performed. Fasting lipid profiles, A1C, and body mass index (BMI) were measured every 6 months for at least 3 yr (median 4.2 yr). Low-density lipoprotein (LDL)-cholesterol, total cholesterol (TC), and triglycerides (TG) were divided into categorical variables. RESULTS: At baseline, median age was 14.3 yr, mean diabetes duration was 6.4 ± 3.8 yr, mean A1C was 8.1 ± 1.0%, and median BMI z-score was 0.92. Fifty percent of subjects had LDL levels ≤ 100 mg/dL (≤ 2.6 mmol/L) at study onset. After adjusting for confounding factors, increasing BMI z-score [ß = 0.2, 95% confidence interval (CI ) = 0.03-0.38, p = 0.03] and increasing A1C (ß = 0.18, 95% CI = 0.08-0.29, p = 0.001) were associated with increasing LDL category over time. Non-Hispanic ethnicity (ß = 0.45, 95% CI = 0.12-0.79, p = 0.008) and family history of stroke (ß = 0.38, 95% CI = 0.04-0.72, p = 0.03) were also associated with increasing LDL category. Age, diabetes duration, and tobacco exposure were not related to change in LDL. Increasing A1C was associated with increases in TG (ß = 18.1, 95% CI = 2.3-33.9, p = 0.03), TC (ß = 20.3, 95% CI = 9.0-31.5, p < 0.0001), and LDL (ß = 13.4, 95% CI = 3.17- 23.6, p = 0.01). CONCLUSION: Glycemic control and BMI are modifiable risk factors for dyslipidemia in youth with type 1 diabetes.
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Diabetes Mellitus Tipo 1/metabolismo , Metabolismo de los Lípidos , Adolescente , Glucemia/metabolismo , Índice de Masa Corporal , Enfermedades Cardiovasculares/etiología , Niño , Colesterol/sangre , LDL-Colesterol/sangre , Dislipidemias/prevención & control , Femenino , Hemoglobina Glucada/metabolismo , Hispánicos o Latinos , Humanos , Estudios Longitudinales , Masculino , Estudios Prospectivos , Factores de Riesgo , Triglicéridos/sangre , Adulto JovenRESUMEN
INTRODUCTION: Continuous glucose monitoring (CGM) systems offer real-time data to facilitate diabetes management. The novel Eversense CGM has been approved in Europe and the US. The unique characteristics are the fully implantable sensor and the sensor life up to 180 days. AREAS COVERED: This expert review describes the results of clinical trials, and the accuracy and safety of the Eversense system. The overall MARD ranges from 8.5% to 9.4%, the 20/20% agreement rate ranges from 84% to 94%, and the percent of values in zones A and B on the Clarke Error Grid is 99.2%. No device-related serious adverse events have been described during pivotal trial studies. The most frequently reported device- or procedure-related adverse events are sensor adhesive patch location site irritation (0.66%), inability to remove the sensor upon first attempt (0.76%), and location site infection (0.96%). Mean A1c reduction is about 0.4% from pivotal trials and real-world studies. EXPERT OPINION: The Eversense system is novel and differentiated from transcutaneous CGM systems. The long life, the removable transmitter, and the on-body vibration alerts offer opportunities to properly manage diabetes with both MDI and insulin pump therapy.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Glucemia , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Control Glucémico , Humanos , Insulina/uso terapéutico , Sistemas de Infusión de InsulinaRESUMEN
OBJECTIVE: The CareLink™ (Medtronic, Inc., Northridge, CA) database houses data from continuous glucose monitoring (CGM), insulin pumps, and blood glucose (BG) meters. This study examined CGM usage and its relationship to insulin delivery and glycemia in CareLink users with type 1 diabetes mellitus (T1DM). METHODS: Users whose CareLink accounts contained =120 days of pump and glucose readings within a 180-day interval were further selected and stratified based on the frequency of CGM use and adequacy of glycemic control; correlations between these variables were sought. RESULTS: The proportion of subjects with pre-specified favorable glycemic parameters rose with increasing sensor use (p<0.001). These subjects administered more and smaller boluses, gave a higher proportion of their total daily dose (TDD) of insulin as boluses, and maintained lower TDDs than those with pre-specified less-favorable glycemic parameters (all p<0.001). CONCLUSIONS: A favorable dose effect of CGM use was evident. CGM data facilitates smaller and more frequent bolus dosing, allowing for improved glycemic control.
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Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Sistemas de Infusión de Insulina/normas , Insulina/administración & dosificación , Monitoreo Ambulatorio/métodos , Adolescente , Adulto , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Ambulatorio/normas , Adulto JovenRESUMEN
Previously, the safety and accuracy of the Eversense continuous glucose monitoring (CGM) system were characterized in three pivotal trials among individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) with a single 90- or 180-day sensor insertion-removal cycle. The Post-Market Clinical Follow-up (PMCF) registry is a prospective study evaluating the long-term safety and performance of the Eversense CGM system over multiple sensor insertion-removal cycles among adults with T1D and T2D. All patients who had a sensor subcutaneously implanted across 534 participating centers in Europe and South Africa from June 2016 to August 2018 were enrolled. Adverse events (AEs) were recorded at each visit and patients were instructed to inform their clinic if they experienced any AEs between visits. AEs were adjudicated for relatedness to the device, procedure, or drug (dexamethasone acetate). The primary safety endpoint was the rate of related serious adverse events (SAEs) through four sensor insertion-removal cycles. The registry enrolled 3023 patients. As of last follow-up, 5417 sensors had been inserted with a total of 1260 patient-years (PYs) of follow-up: 969 patients had used the system for at least 6 months and 173 patients had used the system for at least 1 year. No related SAEs were reported. The most frequently reported related AEs were sensor location site infection (0.96%; 2.46 events per 100 PYs), inability to remove the sensor upon first attempt (0.76%; 1.90 events per 100 PYs), and adhesive patch location site irritation (0.66%; 1.59 events per 100 PYs). One nonserious allergic reaction to lidocaine was reported, which resolved with administration of an antihistamine. The full intended sensor life was achieved by 91% of 90-day sensors and 75% of 180-day sensors. The PMCF registry provides real-world evidence that the Eversense CGM system is safe over multiple cycles of use.
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Glucemia/análisis , Monitoreo Ambulatorio/instrumentación , Sistema de Registros , Dispositivos Electrónicos Vestibles/efectos adversos , Humanos , Vigilancia de Productos Comercializados , Estudios Prospectivos , Dispositivos Electrónicos Vestibles/estadística & datos numéricosRESUMEN
The Eversense® Continuous Glucose Monitoring (CGM) System, with the first long-term, implantable glucose sensor, has been commercially available in Europe and South Africa since 2016 for adults with diabetes. The performance of the sensor over multiple, sequential 90- or 180-day cycles from either real-world experience or clinical studies has not been previously published. The Eversense Data Management System (DMS) was used to evaluate the accuracy of General Data Protection Regulation (GDPR)-compliant sensor glucose (SG) values against self-monitoring of blood glucose (SMBG) from June 2016 through August 2019 among patients with at least four sensor cycles from European and South African health care practices. Mean SG and associated measures of variability, glucose management indicator (GMI), and percent and time in various hypoglycemic, euglycemic, and hyperglycemic ranges were calculated for the 24-h time period over each cycle. In addition, transmitter wear time was evaluated across each sensor wear cycle. Among the 945 users included in the analysis, the mean absolute relative difference (standard deviation [SD]) using 152,206, 174,645, 206,024, and 172,587 calibration matched pairs against SMBG was 11.9% (3.6%), 11.5% (4.0%), 11.8% (4.7%), and 11.5% (4.1%) during the first four sensor cycles, respectively. Mean values of the CGM metrics over the first sensor cycle were 156.5 mg/dL for SG, 54.7 mg/dL for SD, 0.35 for coefficient of variation, and 7.04% for GMI. Percent SG at different glycemic ranges was as follows: <54 mg/dL was 1.1% (16 min), <70 mg/dL was 4.6% (66 min), ≥70-180 mg/dL (time in range) was 64.5% (929 min), >180-250 mg/dL was 22.8% (328 min), and >250 mg/dL was 8.1% (117 min). The median transmitter wear time over the first cycle was 83.2%. CGM metrics and wear time were similar over the subsequent three cycles. This real-world evaluation of adult patients with diabetes using the Eversense CGM System in the home setting demonstrated that the implantable sensor provides consistent stable accuracy and CGM metrics over multiple, sequential sensor cycles with no indication of degradation of sensor performance.
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Automonitorización de la Glucosa Sanguínea/instrumentación , Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 2/sangre , Sistemas de Infusión de Insulina , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéuticoRESUMEN
Background: The Eversense® Continuous Glucose Monitoring (CGM) System, with the first 90-day implantable sensor, received FDA (Food and Drug Administration) approval in June 2018. No real-world experience has been published. Methods: Deidentified sensor glucose (SG) data from August 1, 2018 to May 11, 2019 in the Eversense Data Management System (DMS) were analyzed for the first 205 patients who reached a 90-day wear period on the Eversense CGM system. The mean SG, standard deviation (SD), median interquartile range, coefficient of variation (CV), glucose measurement index (GMI), and percent and time in minutes across glucose ranges were computed for the 24-h time period, the nighttime (00:00-06:00), and by 30-day wear periods. Sensor accuracy, sensor reinsertion rate, transmitter wear time, and safety data were assessed. Results: Of the 205 patients, 129 identified as type 1, 18 as type 2, and 58 were unreported. Fifty were CGM naive, 112 had prior CGM experience, and 43 were unreported. The mean SG was 161.8 mg/dL, SD was 57.4 mg/dL, CV was 0.35, and GMI was 7.18%. Percent SG at <54 mg/dL was 1.2% (18 min), <70 mg/dL was 4.1% (59.7 min), time in range (≥70-180 mg/dL) was 62.3% (897.7 min), >180-250 mg/dL was 21.9% (315.8 min), and >250 mg/dL was 11.6% (166.7 min). Nighttime values were similar. The glucometric values were similar over 30-day time periods of the sensor wear. The mean absolute relative difference (SD) using 27,708 calibration paired points against home blood glucose meters was 11.2% (11.3%). The sensor reinsertion rate was 78.5%. The median transmitter wear time was 83.6%. There were no related serious adverse events. Conclusion: The Eversense real-world data showed promising glycemic results, sensor accuracy, and safety. These data suggest that the Eversense CGM system is a valuable tool for diabetes management.
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Automonitorización de la Glucosa Sanguínea/instrumentación , Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 2/sangre , Adulto , Femenino , Humanos , Masculino , Estados UnidosRESUMEN
BACKGROUND: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. METHODS: SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. FINDINGS: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect -2·9 [95% CI -3·5 to -2·3]; p<0·0001) and fewer severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall (three vs 18; p=0·0036). The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76). No serious adverse device effects or episodes of diabetic ketoacidosis were reported. INTERPRETATION: Insulin pump therapy with integrated CGM and a suspend-before-low feature reduced the frequency of sensor hypoglycaemic and severe hypoglycaemic events in hypoglycaemia-prone adults compared with use of continuous subcutaneous insulin infusion without real-time CGM. These results suggest that this technology could be beneficial in this high-risk population. FUNDING: Medtronic International Trading Sàrl and Medtronic Canada.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina/estadística & datos numéricos , Insulina/administración & dosificación , Adulto , Femenino , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D). METHODS: Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA1c), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT® venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitoring performance. RESULTS: Auto Mode was used a median of 81% of the time. From baseline to end of study, overall SG dropped by 6.9 ± 17.2 mg/dL (P < 0.001), HbA1c decreased from 7.9% ± 0.8% to 7.5% ± 0.6% (P < 0.001), percentage of time in target glucose range (70-180 mg/dL) increased from 56.2% ± 11.4% to 65.0% ± 7.7% (P < 0.001), and the SG coefficient of variation decreased from 39.6% ± 5.4% to 38.5% ± 3.8% (P = 0.009). The percentage of SG values within target glucose range was 68.2% ± 9.1% and that of i-STAT reference values was 65.6% ± 17.7%. The percentage of values within 20%/20 of the i-STAT reference was 85.2%. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study phase. CONCLUSION: In-home use of MiniMed 670G system Auto Mode for 3 months by children with T1D, similar to MiniMed 670G system use by adolescents and adults with T1D, was safe and associated with reduced HbA1c levels and increased time in target glucose range, compared with baseline.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina/estadística & datos numéricos , Insulina/administración & dosificación , Adolescente , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea , Niño , Diabetes Mellitus Tipo 1/sangre , Femenino , Hemoglobina Glucada/análisis , Humanos , Masculino , Resultado del TratamientoRESUMEN
OBJECTIVE: Our objective was to formulate practice guidelines for the treatment and prevention of pediatric obesity. CONCLUSIONS: We recommend defining overweight as body mass index (BMI) in at least the 85th percentile but < the 95th percentile and obesity as BMI in at least the 95th percentile against routine endocrine studies unless the height velocity is attenuated or inappropriate for the family background or stage of puberty; referring patients to a geneticist if there is evidence of a genetic syndrome; evaluating for obesity-associated comorbidities in children with BMI in at least the 85th percentile; and prescribing and supporting intensive lifestyle (dietary, physical activity, and behavioral) modification as the prerequisite for any treatment. We suggest that pharmacotherapy (in combination with lifestyle modification) be considered in: 1) obese children only after failure of a formal program of intensive lifestyle modification; and 2) overweight children only if severe comorbidities persist despite intensive lifestyle modification, particularly in children with a strong family history of type 2 diabetes or premature cardiovascular disease. Pharmacotherapy should be provided only by clinicians who are experienced in the use of antiobesity agents and aware of the potential for adverse reactions. We suggest bariatric surgery for adolescents with BMI above 50 kg/m(2), or BMI above 40 kg/m(2) with severe comorbidities in whom lifestyle modifications and/or pharmacotherapy have failed. Candidates for surgery and their families must be psychologically stable and capable of adhering to lifestyle modifications. Access to experienced surgeons and sophisticated multidisciplinary teams who assess the benefits and risks of surgery is obligatory. We emphasize the prevention of obesity by recommending breast-feeding of infants for at least 6 months and advocating that schools provide for 60 min of moderate to vigorous daily exercise in all grades. We suggest that clinicians educate children and parents through anticipatory guidance about healthy dietary and activity habits, and we advocate for restricting the availability of unhealthy food choices in schools, policies to ban advertising unhealthy food choices to children, and community redesign to maximize opportunities for safe walking and bike riding to school, athletic activities, and neighborhood shopping.
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Obesidad , Complicaciones del Embarazo , Adulto , Niño , Preescolar , Femenino , Humanos , Lactante , Recién Nacido , Embarazo , Fármacos Antiobesidad/uso terapéutico , Cirugía Bariátrica , Índice de Masa Corporal , Dieta , Medicina Basada en la Evidencia , Estilo de Vida , Actividad Motora , Obesidad/diagnóstico , Obesidad/prevención & control , Complicaciones del Embarazo/diagnóstico , Complicaciones del Embarazo/dietoterapia , Complicaciones del Embarazo/tratamiento farmacológico , Complicaciones del Embarazo/prevención & control , Apoyo SocialRESUMEN
BACKGROUND: The objective of the study was to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems. METHODS: This 6-month, randomized, multicenter, treat-to-target study enrolled 146 subjects treated with continuous subcutaneous insulin infusion between the ages of 12 and 72 years with type 1 diabetes and initial A1C levels of >or=7.5%. Subjects were randomized to pump therapy with real-time CGM (sensor group [SG]) or to pump therapy and self-monitoring of blood glucose only (control group [CG]). Clinical effectiveness and safety were evaluated. RESULTS: A1C levels decreased (P<0.001) from baseline (8.44+/-0.70%) in both groups (SG, -0.71+/-0.71%; CG, -0.56+/-0.072%); however, between-group differences did not achieve significance. SG subjects showed no change in mean hypoglycemia area under the curve (AUC), whereas CG subjects showed an increase (P=0.001) in hypoglycemia AUC during the blinded periods of the study. The between-group difference in hypoglycemia AUC was significant (P<0.0002). Greater than 60% sensor utilization was associated with A1C reduction (P=0.0456). Fourteen severe hypoglycemic events occurred (11 in the SG group and three in the CG group, P=0.04). CONCLUSIONS: A1C reduction was no different between the two groups. Subjects in the CG group had increased hypoglycemia AUC and number of events during blinded CGM use; however, there was no increase in hypoglycemia AUC or number of events in the SG group. Subjects with greater sensor utilization showed a greater improvement in A1C levels.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Adolescente , Adulto , Anciano , Glucemia/metabolismo , Niño , Diabetes Mellitus Tipo 1/sangre , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Hiperglucemia/sangre , Hiperglucemia/prevención & control , Hipoglucemia/sangre , Hipoglucemia/prevención & control , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Sistemas de Infusión de Insulina/efectos adversos , Masculino , Persona de Mediana Edad , Cooperación del Paciente , Resultado del TratamientoRESUMEN
BACKGROUND: Atherosclerosis appears to begin in youth with type 1 diabetes mellitus (T1DM). Highly sensitive C-reactive protein (hsCRP) is an independent marker of cardiovascular disease (CVD) risk in adults, but its relation to dyslipidemia and other CVD risk factors in adolescents with T1DM is unknown. OBJECTIVE: To study the association between lipids and hsCRP in youth with T1DM. DESIGN: Cross-sectional cohort. METHODS: hsCRP and fasting lipids were measured in 74 patients with T1DM, mean age 16.2 +/- 2.62 yr, mean duration of diabetes 7.3 +/- 4.0 yr, and mean hemoglobin A1c (HbA1c) 8.5 +/- 1.3%. According to the American Heart Association/Centers for Disease Control recommendations, hsCRP values were divided into three groups: group 1: <1.0 mg/L, low CVD risk; group 2: 1.0-3.0 mg/L, average CVD risk; and group 3: >3 mg/L, high CVD risk. Univariate linear regression between hsCRP and lipid and clinical parameters was used, with adjustment for age. RESULTS: hsCRP was significantly associated with triglycerides (Tg), apoB, systolic blood pressure (SBP), and diastolic blood pressure (DBP). Subjects in the high CVD risk group had no further worsening of lipids or BP, except for a higher Tg level. ApoB, SBP, and DBP were elevated in females with hsCRP > or =1 compared with the low-risk group, and high-density lipoprotein was decreased. In males, this difference was only significant for SBP. CONCLUSIONS: Elevation of hsCRP to a level > or =1.0 mg/L appears to be associated with elevated lipid levels in adolescents with T1DM, particularly in females. hsCRP is a marker in youth that clusters with dyslipidemia and may indicate an increased CVD risk in youth with T1DM.
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Proteína C-Reactiva/metabolismo , Diabetes Mellitus Tipo 1/sangre , Lípidos/sangre , Adolescente , Adulto , Edad de Inicio , Glucemia/metabolismo , Presión Sanguínea , Niño , Estudios Transversales , Diabetes Mellitus Tipo 1/fisiopatología , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Masculino , Selección de Paciente , Medición de Riesgo , Sensibilidad y EspecificidadRESUMEN
Transition to adulthood for young people with diabetes is a critical milestone in their lives. It is a time when many facets of life are changing simultaneously. It is most important to recognize the special needs of adolescents with diabetes during this period. A successful and smooth transition of diabetes care should be based on a well-organized plan that includes the young person and the family. The process should be facilitated by collaboration between the pediatric and adult clinics. It should be guided by structured policies and guidelines, including posttransition evaluation. Finally, it should be a process, not an event. The school nurse can play a critical role in its success.
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Servicios de Salud del Adolescente/organización & administración , Continuidad de la Atención al Paciente/organización & administración , Diabetes Mellitus/prevención & control , Pediatría/organización & administración , Servicios de Enfermería Escolar/organización & administración , Adolescente , Adulto , Niño , Servicios de Salud del Niño/organización & administración , Necesidades y Demandas de Servicios de Salud , Humanos , Modelos de Enfermería , Modelos Organizacionales , Rol de la Enfermera , Evaluación de Resultado en la Atención de Salud , Enfermería Pediátrica/organización & administraciónRESUMEN
INTRODUCTION: Glycated hemoglobin (A1C) is considered a "gold standard" measure of glycemic control in patients with diabetes and is correlated with a lower risk of diabetes complications and cost savings. This retrospective claims-analysis assessed the impact of A1C reduction on healthcare costs in patients with uncontrolled Type 1 and Type 2 diabetes. METHODS: Using a large repository of US health plan administrative data linked to A1C values, patients with a diabetes diagnosis and at least two A1C values between 1 January 2009 and 31 December 2014 were selected to identify changes in A1C and associated changes in healthcare expenditure. We used all medical and pharmacy claims to calculate direct healthcare costs from 1 year prior to the index A1C to 2 years after the index A1C. A propensity score method was used to match patients with decreased A1C to patients whose A1C did not decrease, based on potentially confounding variables. Then, a generalized linear model regression was used to estimate the difference-in-difference (DD) effect on costs between the two groups. RESULTS: Of the 3,197 patients who had a first A1C ≥ 9%, 2,273 patients (71%) had a decrease in A1C (Decreasers) and 924 patients (27%) had an increase in A1C (Non-decreasers). After matching, we compared 912 Decreasers to 912 Non-decreasers. Patients in the former group had average annual healthcare costs that were 24% lower during the first year of follow-up and 17% lower during the second year of follow-up, compared to patients whose A1C did not decrease. This reflected a savings of US$2503 and US$1690, respectively. For both time periods, the outpatient category was the largest contributor to cost savings. DISCUSSION: In our analysis, A1C reduction among patients with T1DM and T2DM was associated with slower growth in healthcare costs within 1-2 years. These findings suggest that programs aimed at reducing A1C over a short timeframe may lead to substantial savings and may be worth pursuing by health plans and other payers.
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Diabetes Mellitus/economía , Hemoglobina Glucada/análisis , Costos de la Atención en Salud/estadística & datos numéricos , Complicaciones de la Diabetes/economía , Complicaciones de la Diabetes/epidemiología , Diabetes Mellitus/sangre , Diabetes Mellitus/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: It is estimated that one in 10 people in the US have a diagnosis of diabetes. Type 2 diabetes accounts for 95% of all cases in the US, with annual costs estimated to be $246 billion per year. This study investigated the impact of a glucose-measuring intervention to the burden of type 2 diabetes. OBJECTIVE: This analysis seeks to understand how professional continuous glucose monitoring (professional CGM) impacts clinical and economic outcomes when compared to patients who are not prescribed professional CGM. METHODS: This study utilized a large healthcare claims and lab dataset from the US, and identified a cohort of patients who were prescribed professional CGM as identified by CPT codes 95250 and 95251. It calculated economic and clinical outcomes 1 year before and 1 year after the use of professional CGM, using a generalized linear model. RESULTS: Patients who utilized professional CGM saw an improvement in hemoglobin A1C. The "difference-in-difference" calculation for A1C was shown to be -0.44%. There was no statistically significant difference in growth of total annual costs for people who used professional CGM compared to those who did not ($1,270, p = .08). Patients using professional CGM more than once per year had a -$3,376 difference in the growth of total costs (p = .05). Patients who used professional CGM while changing their diabetes treatment regimen also had a difference of -$3,327 in growth of total costs (p = .0023). CONCLUSION: Significant clinical benefits were observed for patients who used professional CGM. Economic benefits were observed for patients who utilized professional CGM more than once within a 1-year period or who used it during a change of diabetes therapy. This suggests that professional CGM may help decrease rising trends in healthcare costs for people with type 2 diabetes, while also improving clinical outcomes.
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Automonitorización de la Glucosa Sanguínea/economía , Costo de Enfermedad , Diabetes Mellitus Tipo 2/fisiopatología , Revisión de Utilización de Seguros , Evaluación de Resultado en la Atención de Salud , Current Procedural Terminology , Bases de Datos Factuales , Femenino , Hemoglobina Glucada/análisis , Gastos en Salud , Humanos , Seguro de Salud/economía , Masculino , Persona de Mediana Edad , Salud Poblacional , Estados UnidosRESUMEN
Real-world data from the first 3141 patients who completed 3 months of SmartGuard™ Auto Mode-enabled MiniMed™ 670G system use during the MiniMed 670G System Commercial Launch are reported. CareLink™ system data uploaded by real-world patients in the Commercial Launch from March 17, 2017 to December 31, 2017 were deidentified and analyzed. Comparisons of overall and night (10:00 PM-07:00 AM) time spent below, within, and above target glucose range (TIR) (70-180 mg/dL) between the baseline Manual Mode and closed-loop Auto Mode periods were made. These were evaluated alongside data from the 124 patients (aged 14-75 years) who completed the 3-month MiniMed 670G system pivotal trial (NCT 2463097), from June 2, 2015 to March 7, 2016. Real-world patients used Auto Mode a median 80.8% of the time (19 h and 24 min of the day). The overall mean of time spent in TIR was 66.0% during baseline Manual Mode versus 73.3% during Auto Mode (P < 0.001); the mean percentage of sensor glucose values <70 mg/dL was 2.7% versus 2.1% (P < 0.001); and that >180 mg/dL was 31.4% versus 24.6% (P < 0.001). The nighttime and early morning (03:00 AM-06:00 AM) TIR during Auto Mode was greater than that during baseline Manual Mode (nighttime: 77.2% vs. 67.4% [P < 0.001], early morning: 70.9% vs. 84.6% [P < 0.001]). Similar differences between Manual Mode and Auto Mode TIR were observed across different age groups. A slight increase in total insulin delivered was also observed. Consistent with improved glycemic control demonstrated in the pivotal trial, analysis of CareLink system data from >3000 real-world patients who completed 3 months of Auto Mode-enabled MiniMed 670G system use demonstrated increased TIR and decreased time below and above TIR compared with baseline. These improved clinical outcomes were observed across a broad age range of patients with type 1 diabetes.