In this study involving patients with type 1 diabetes, sensor-augmented insulin-pump therapy plus automated insulin suspension when glucose dropped below 70 mg per deciliter reduced nocturnal ...hypoglycemia, without affecting glycated hemoglobin values.
Severe nocturnal hypoglycemia can be catastrophic,
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and hypoglycemia remains one of the most formidable barriers to improving glycemic control in patients with diabetes.
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Sensor-augmented insulin-pump therapy offers substantial glycemic benefits, as compared with multiple daily insulin injections, but has not been shown to lower the risk of severe hypoglycemia significantly.
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The automatic suspension of insulin delivery when a preset sensor glucose threshold is reached has the potential to mitigate hypoglycemia. The low-glucose suspend feature, available in the Medtronic Paradigm Veo pump outside the United States since 2009, was used in this study in the intervention group; the feature allows . . .
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.
Background: Multiple pivotal and post market studies have confirmed the safety and accuracy of implantable Eversense CGM Systems. A post market study was initiated to compare Eversense 90-day and ...180-day systems to SMBG in CGM naïve patients. Methods: This post market study is a prospective, multicenter, one year comparison of SMBG to Eversense in CGM naïve adults with diabetes in US sites (up to 925 users). After baseline assessment including HbA1c, patients used SMBG for 6 months (phase 1) followed by Eversense for 6 months (phase 2). Sensors were inserted at the start of phase 2. Visits occurred q 90 days to collect SMBG or CGM data and assess adverse events. HbA1c was measured at 6 and 12 months. Glucometrics were calculated in both phases. Enrollment and follow-up visits are ongoing.
Results: In 15 sites, 84 users have completed the study (mean 47.6% male, 90.5% type 2 diabetes, 57.2 years age). In the initial users, reductions in HbA1c were seen in both phases and improvements in glucometrics were observed (Table) with CGM compared to SMBG.
Conclusion: In a CGM naïve population, 6 months of SMBG use reduced HbA1c. There was a further significant reduction after 6 months of using Eversense CGM, as well as significant improvement in glucometrics - an increase in Time in Range (70-180 mg/dL) with no increase Time below Range. These data suggest that Eversense CGM improves glucose management compared to SMBG.
Disclosure
K.S.Tweden: Employee; Senseonics. B.Romarowski: Employee; Senseonics. C.Mdingi: Employee; Senseonics. F.R.Kaufman: Consultant; MannKind Corporation, Twin Health, Stock/Shareholder; Senseonics.
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/m2, or BMI above 40 kg/m2 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.
Pediatric obesity can lead to concurrent co-morbidities. Intensive lifestyle modification remains the primary treatment. Carefully selected patients with severe co-morbidities may benefit from the addition of pharmacotherapy and/or bariatric surgery. Because treatment is difficult, prevention is the ultimate goal.
Context: The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) cohort represents the largest and best-characterized national sample of American youth with recent-onset type 2 ...diabetes.
Objective: The objective of the study was to describe the baseline characteristics of participants in the TODAY randomized clinical trial.
Design: Participants were recruited over 4 yr at 15 clinical centers in the United States (n = 704) and enrolled, randomized, treated, and followed up 2–6 yr.
Setting: The study was conducted at pediatric diabetes care clinics and practices.
Participants: Eligible participants were aged 10–17 yr inclusive, diagnosed with type 2 diabetes for less than 2 yr and had a body mass index at the 85th percentile or greater.
Interventions: After baseline data collection, participants were randomized to one of the folllowing groups: 1) metformin alone, 2) metformin plus rosiglitazone, or 3) metformin plus a lifestyle program of weight management.
Main Outcome Measures: Baseline data presented include demographics, clinical/medical history, biochemical measurements, and clinical and biochemical abnormalities.
Results: At baseline the cohort included the following: 64.9% were female; mean age was 14.0 yr; mean diabetes duration was 7.8 months; mean body mass index Z-score was 2.15; 89.4% had a family history of diabetes; 41.1% were Hispanic, 31.5% were non-Hispanic black; 38.8% were living with both biological parents; 41.5% had a household annual income of less than $25,000; 26.3% had a highest education level of parent/guardian less than a high school degree; 26.3% had a blood pressure at the 90th percentile or greater; 13.6% had a blood pressure at the 95th percentile or greater; 13.0% had microalbuminuria; 79.8% had a low high-density lipoprotein level; and 10.2% had high triglycerides.
Conclusions: The TODAY cohort is predominantly from racial/ethnic minority groups, with low socioeconomic status and a family history of diabetes. Clinical and biochemical abnormalities and comorbidities are prevalent within 2 yr of diagnosis. These findings contribute greatly to our understanding of American youth with type 2 diabetes.
The TODAY cohort, representing the largest and best-characterized national sample of American youth with type 2 diabetes, is described at baseline.
To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D).
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 (HbA
), 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.
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), HbA
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.
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 HbA
levels and increased time in target glucose range, compared with baseline.
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.
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.
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.
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.
Automated insulin management features of the MiniMed
640G sensor-augmented pump system include suspension in response to predicted low sensor glucose (SG) values ("suspend before low"), suspension in ...response to existing low SG values ("suspend on low"), and automatic restarting of basal insulin delivery upon SG recovery. The effectiveness of these features was evaluated using CareLink
software data.
Anonymized data from MiniMed 640G system users (n = 4818), MiniMed 530G system users (n = 39,219), and MiniMed Paradigm
Veo™ system users (n = 43,193) who voluntarily uploaded pump and sensor data were retrospectively analyzed. Comparisons were made between days in which system features were enabled at any time and those in which they were not. Comparisons were also made between pump suspension events for which insulin delivery was automatically or manually resumed and between glycemic parameters of users who switched from the MiniMed Paradigm Veo system to the MiniMed 640G system.
Days in which the MiniMed 640G "suspend before low" feature was enabled had lower percentages of SG readings ≤70 mg/dL (3.9 mmol/L) or ≥240 mg/dL (13.3 mmol/L) than days when it was not enabled (P < 0.001 for each). Users who switched from the MiniMed Paradigm Veo system to the MiniMed 640G system had fewer excursions below ≤70 mg/dL (P < 0.001) and ≥240 mg/dL (P < 0.001). SG values following automatically resumed pump suspension events recovered more rapidly and had a more stabilized endpoint than following manually resumed events.
Automated insulin management features of the MiniMed 640G system can reduce the frequency of both high and low SG values and help stabilize SG after resumption of insulin delivery.
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