Sensor-augmented Insulin Pump Therapy Research Articles

Characteristics Associated With Elevated Time Below Range in Elderly Patients With Type 1 Diabetes Using an Automated Insulin Delivery System.

This study investigated the characteristics associated with an increased risk of hypoglycemia, in elderly patients with type 1 diabetes mellitus (T1D) using automated insulin delivery (AID) systems. Cross-sectional observational study including patients >60 years, using sensor-augmented insulin pump therapy with predictive low-glucose management (SAPT-PLGM), hybrid closed-loop (HCL), and advanced hybrid closed-loop (AHCL), for more than three months. A geriatric assessment was performed, and body composition was determined to investigate its association with achieving time below range (TBR) <70 mg/dL goals. The study included 59 patients (47.5% of men, mean age of 67.6 years, glycated hemoglobin [HbA1c] of 7.5 ± 0.6%, time in range (TIR) 77.8 ± 9.9%). Time below range <70 and <54 mg/dL were 2.2 ± 2.3% and 0.4 ± 0.81%, respectively. Patients with elevated TBR <70 mg/dL (>1%) had higher HbA1c levels, lower TIR, elevated time above range (TAR), and high glycemic variability. Regarding body composition, greater muscle mass, grip strength, and visceral fat were associated with a lower TBR <70 mg/dL. These factors were independent of the type of technology used, but TIR was higher when using AHCL systems compared with SAPT-PLGM and HCL systems. In elderly patients treated with AID systems with good functional status, lower lean mass, lower grip strength, and lower visceral fat percentage were associated with TBR greater than 1%, regardless of the device used. A similar finding along was found with CGM indicators such as higher HbA1c levels, lower TIR, higher TAR, and higher CV. Geriatric assessment is crucial for personalizing patient management.

Advantages of sensor-augmented insulin pump therapy for pregnant women with type 1 diabetes mellitus.

To evaluate the efficacy of sensor-augmented pump (SAP) for improving obstetric and neonatal outcomes among pregnant women with type 1 diabetes mellitus by comparing it with continuous subcutaneous insulin infusion plus self-monitoring of blood glucose (continuous subcutaneous insulin infusion [CSII]/SMBG). This retrospective cohort study included 40 cases of pregnancy complicated by type 1 diabetes mellitus treated with SAP (SAP group), and 29 cases of pregnancy complicated by type 1 diabetes mellitus treated with CSII/SMBG (CSII/SMBG group). The obstetric and neonatal outcomes were compared between the two groups. The median of the glycoalbumin levels in the first (18.8% vs 20.9%; P < 0.05) and second (15.4% vs 18.0%; P < 0.05) trimesters, the hemoglobin A1c levels in the peripartum period (6.1% vs 6.5%; P < 0.05) and the standard deviation score of birthweights (0.36 vs 1.52; P < 0.05) were significantly lower in the SAP group than in the CSII/SMBG group. The incidence rate of large for gestational age newborns was significantly lower in the SAP group than in the CSII/SMBG group (27.5% vs 65.5%; P < 0.05). No significant differences in the incidence rates of hypertensive disorders of pregnancy, small for gestational age, respiratory distress syndrome, neonatal hypoglycemia, hypervolemia and hyperbilirubinemia were observed between the groups. The present study showed that SAP therapy is more effective in preventing large for gestational age newborns in pregnant women with type 1 diabetes mellitus than CSII/SMBG.

Nighttime hypoglycemia in Japanese children with type 1 diabetes mellitus treated with multiple daily injection insulin therapy.

Prevention of hypoglycemia is an important strategy for glycemic management in patients with type 1 diabetes mellitus (T1D). Hypoglycemia is difficult to recognize at night while sleeping, particularly when using multiple daily injection (MDI) insulin therapy rather than sensor-augmented insulin-pump therapy. Therefore, it is possible that patients with T1D are at higher risk of nocturnal hypoglycemia when insulin is administered using an MDI regimen. We investigated nocturnal hypoglycemia in 50 pediatric patients with T1D on MDI insulin therapy using data from an intermittently scanned continuous glucose monitoring (isCGM) system. Hypoglycemia was observed on 446 of the 1,270 nights studied. Most of the hypoglycemic episodes were severe (blood glucose <54 mg/dL). On nights when hypoglycemia occurred, the blood glucose concentrations measured using finger-stick blood glucose monitoring (FSGM) before sleep and the next morning were lower than nights when hypoglycemia did not occur. However, few values were below the normal blood glucose range, suggesting that FSGM alone may be insufficient to detect nocturnal hypoglycemia. Approximately 7% of time was spent below the normal glucose range during the 10 hours from 21:00 to 7:00 the next morning. This result suggests that the patients on MDI insulin therapy could end up spending more time in hypoglycemia than is recommended by the American Diabetes Association (time below range <4.0% of time per day). Monitoring glucose levels overnight using an isCGM sensor may improve glycemic management via automatic detection of blood glucose peaks and troughs.

Glucose profiles of older adults with type 1 diabetes using sensor-augmented pump therapy in Australia: pre-randomisation results from the ORACL study

Older adults with type 1 diabetes are recommended modified glucose targets. However, data on the effects of diabetes technology in older age are scarce. We assessed older adults established on sensor-augmented insulin pump therapy during clinical trial run-in and compared their continuous glucose monitoring (CGM) profiles with consensus recommendations. We aimed to provide insight into the applicability of currently recommended CGM-based targets while accounting for current Diabetes UK guidelines. In this analysis, adults aged 60 years or older with type 1 diabetes with a duration of at least 10 years and entering the Older Adult Closed Loop (ORACL) trial were studied. The trial was done at two tertiary hospitals in Australia. Individuals who were independent with diabetes self-management, as well as those receiving caregiver assistance for their diabetes management, were eligible for inclusion. Participants underwent baseline clinical assessment, which included medical history and examination, testing for frailty, functional ability, cognitive functioning, psychosocial wellbeing, and subjective sleep quality; fasting venous blood samples were collected for C-peptide, glucose, and glycated haemoglobin A1c measurement. Sensor-augmented pumps, carbohydrate-counting education, and diabetes education were provided to participants by diabetes nurse educators, dietitians, and endocrinologists experienced in type 1 diabetes clinical care. CGM data were subsequently collected for 2 weeks during sensor-augmented pump therapy. The ORACL trial is registered with the Australian New Zealand Clinical Trial Registry, ACTRN12619000515190. Our analysis included all 30 participants who completed the ORACL trial run-in-19 (63%) women and 11 (37%) men (mean age 67 years [SD 5], median diabetes duration 38 years [IQR 20-47], and insulin total daily dose 0·55 units [0·41-0·66] per kg bodyweight). Ten (33%) of 30 participants had impaired hypoglycaemia awareness and six (20%) were pre-frail; none were frail. The median CGM time in range 3·9-10·0 mmol/L was 71% (IQR 64-79). The time spent with glucose above 10·0 mmol/L was 27% (18-35) and above 13·9 mmol/L was 3·9% (2·4-10·2). The time with glucose below 3·9 mmol/L was 2·0% (1·2-3·1) and the time below 3·0 mmol/L was 0·2% (0·1-0·4). Only two (7%) of 30 participants met all CGM-based consensus recommendations modified for older adults. Time in hypoglycaemia was lower among the 16 participants with predictive low-glucose alerts enabled than among the 14 participants not using predictive low-glucose alerts (median difference -1·1 percentage points [95% CI -2·0 to -0·1]; p=0·038). This difference was even greater overnight (-2·3 percentage points [-3·2 to -1·0]; p=0·0018). One serious adverse event occurred (elective cardiac stent). Using sensor-augmented pumps after multidisciplinary education, this group of older adults without frailty achieved a time in range far exceeding minimum consensus recommendations. However, the current stringent hypoglycaemia recommendations for all older adults were not met. Predictive low alerts could reduce hypoglycaemia, particularly overnight. Investigation into the effectiveness of CGM-based targets that consider frailty, functional status, and diabetes therapies for older adults is warranted. JDRF and Diabetes Australia.

Diabete hi-tech

Recently, technological innovations have radically changed diabetes care. Insulin pumps and continuous glucose monitoring systems have significantly improved diabetes outcomes in both children and adults with Type 1 diabetes. For this reason, the major international associations recommend the use of technology in the management of Type 1 diabetes. The limitations of glycemic self-monitoring have prompted research to develop alternative techniques, favouring the expansion of continuous blood glucose monitoring systems (CGMs). CGM measures interstitial glucose through tiny sensors inserted in the subcutaneous tissue. Sensors can provide information in real time on the current glucose level and its trend. These data can be uploaded to the cloud and checked any time by doctors, patients and their caregivers. CGM can be combined with multiple daily injections (MDI) therapy or continuous subcutaneous insulin infusion (CSII). With CSII, basal insulin is supplied in the form of a continuous infusion and pre-meal bolus doses are calculated based on the meals’ carbohydrate content. A variety of insulin pumps is available, some of which can communicate with specific CGM devices, helping the patient to make better decisions about insulin dosing. This approach is known as sensor-augmented insulin pump therapy and it is the gold standard for the treatment of Type 1 diabetes in children and young adults, as recommended by the Italian Association of Paediatric Endocrinology and Diabetology. In the most recent systems, basal insulin delivery can be automatically modified through algorithms, based on CGM results, target glucose and the amount of active insulin, even though the patients still have to set the pre-meal insulin bolus manually. This system is defined as a partially hybrid closed-loop system, also known as artificial pancreas. Compared to MDI, CSII is associated with better control of blood glucose - measured by haemoglobin A1c and glycemic variability -, reduction of daily insulin requirement and an improvement of the quality of life. Psychophysical disabilities, language barriers or socio-economic disadvantage should not be considered limitations of CSII treatment as long as the caregiver is able to manage the therapy. Nowadays, MDI is recommended as first line therapy exclusively for those patients who do not want to use insulin pumps due to physical discomfort. The aim of this article is to provide updated information on the management of paediatric diabetes with modern technological devices for glucose monitoring and insulin delivery.

Diabetestechnologie in der Schwangerschaft

The use of diabetes technology in pregnant women with type 1 diabetes, as well as in gestational diabetes and type 2 diabetes is becoming increasingly important. In the phase of increasing insulin resistance, especially in the second trimester, the focus is to adjust insulin therapy based on continuous glucose monitoring (CGM) targets. This requires proper bolus management and aggressive injection–eating intervals. In addition, it is essential that counseling have a strong focus on women’s eating behaviors, due to the high potential in terms of glycemic control. Sensor-augmented insulin pump therapy is used without trial data (low suspend, predictive low-glucose suspend, hybrid closed loop) and a few studies are expected to be undertaken in the near future, leaving observation as the only viable option for now. Artificial pancreas systems are the future, both in terms of control and well-being.

Mitchell-Riley Syndrome: Improving Clinical Outcomes and Searching for Functional Impact of RFX-6 Mutations.

Aims/HypothesisCaused by biallelic mutations of the gene encoding the transcription factor RFX6, the rare Mitchell–Riley syndrome (MRS) comprises neonatal diabetes, pancreatic hypoplasia, gallbladder agenesis or hypoplasia, duodenal atresia, and severe chronic diarrhea. So far, sixteen cases have been reported, all with a poor prognosis. This study discusses the multidisciplinary intensive clinical management of 4 new cases of MRS that survived over the first 2 years of life. Moreover, it demonstrates how the mutations impair the RFX6 function.MethodsClinical records were analyzed and described in detail. The functional impact of two RFX6R181W and RFX6V506G variants was assessed by measuring their ability to transactivate insulin transcription and genes that encode the L-type calcium channels required for normal pancreatic beta-cell function.ResultsAll four patients were small for gestational age (SGA) and prenatally diagnosed with duodenal atresia. They presented with neonatal diabetes early in life and were treated with intravenous insulin therapy before switching to subcutaneous insulin pump therapy. All patients faced recurrent hypoglycemic episodes, exacerbated when parenteral nutrition (PN) was disconnected. A sensor-augmented insulin pump therapy with a predictive low-glucose suspension system was installed with good results. One patient had a homozygous c.1517T>G (p.Val506Gly) mutation, two patients had a homozygous p.Arg181Trp mutation, and one patient presented with new compound heterozygosity. The RFX6V506G and RFX6R181W mutations failed to transactivate the expression of insulin and genes that encode L-type calcium channel subunits required for normal pancreatic beta-cell function.Conclusions/InterpretationMultidisciplinary and intensive disease management improved the clinical outcomes in four patients with MRS, including adjustment of parenteral/oral nutrition progression and advanced diabetes technologies. A better understanding of RFX6 function, in both intestine and pancreas cells, may break ground in new therapies, particularly regarding the use of drugs that modulate the enteroendocrine system.

767-P: Changes in Ambulatory Glucose Profile (AGP) in Patients with Type 1 Diabetes Mellitus after Switching from Sensor-Augmented Insulin Pump Therapy to a Do-it-Yourself Artificial Pancreas System: A Retrospective Data Analysis of Real-World Data

Background: Many patients with type 1 diabetes mellitus are switching from sensor-augmented insulin pump therapy to an artificial pancreas system for various reasons. Since there are no suitable approved Automated Insulin Delivery -AID system in Austria, open-source systems are increasingly being used. The question arises, how does glycemic control change after switching? Methods: This monocentric retrospective data analysis from 20to 2021 will compare sensor-augmented pump therapy with the open-source AID system using AGP profiles from 25 patients with type 1 diabetes mellitus. The AGP are generated from sensor data 4 weeks with pump therapy AGP1 and 4 weeks with open-source AID system AGP2. AGP is generated with Dexcom application. Results: Comparing AGP1 and 2 shows a significant reduction of mean glucose from 143mg/dl to 125mg/dl and glucose variability from 50mg/dl to 40mg/dl. The time in target range can be increased from 74% to 84% without changing the time in hypoglycemia. Time in hyperglycemia above 180 and 250 mg/dl and GMI decreased significantly. Conclusion: Open-source AID system can achieve an improvement in glycemic control. In this data analysis, the open-source AID systems can be considered safe due to the lack of increase in hypoglycemia. Disclosure M. Mueller-Korbsch: Research Support; Dexcom, Inc.

Closed-Loop Insulin Pump Therapy in Young Type 1 Diabetic Children

Source: Ware J, Allen JM, Boughton CK, et al. Randomized trial of closed-loop control in very young children with type 1 diabetes. N Engl J Med. 2022;386:209-219; doi: 10.1056/NEJMoa2111673Investigators from multiple institutions conducted a crossover randomized trial to compare the effectiveness and safety of a closed-loop system (ie, artificial pancreas) to sensor-augmented insulin pump therapy in young children with type 1 diabetes. Participants were children 1-7 years old with a diagnosis of type 1 diabetes for at least 6 months, recruited from diabetes centers in 4 European countries. The closed-loop system consisted of a continuous glucose sensor and insulin pump connected to a smartphone app. The app included an algorithm that automatically adjusted insulin delivery based on real-time sensor glucose readings. With the sensor-augmented pump, insulin therapy was stopped if an algorithm predicted that sensor glucose levels were likely to drop below a specified threshold. Study children were randomized to receive 16 weeks of treatment with the closed loop system, followed by 16 weeks using the augmented-sensor pump, or vice versa. The primary outcome was percentage of time spent in the target glucose range (70 to 170 mg/dL) during each treatment period. Secondary outcomes included percentage of time spent in a hyperglycemic range (>180 mg/dL) and hypoglycemic range (<70 mg/dL) and mean glucose levels. These outcomes were based on readings from the glucose sensors. Glycated hemoglobin levels were measured at baseline and at the end of each treatment period. Differences in outcomes between the closed-loop and sensor-augmented pump treatment period were assessed with repeated-measures linear regression models. Data on adverse events also were collected.Data were analyzed on 74 children with a mean age of 5.6 ±1.6 years. The mean glycated hemoglobin level at baseline was 7.3 ±0.7%. The mean time spent in the target glucose range were 71.6 ±5.9% during the closed-loop period and 62.9 ±9.0% in the sensor-augmented pump period (adjusted difference, 8.7 percentage points; 95% CI, 7.4, 9.9; P <0.001). The median time spent at glucose level >180 mg/dL was significantly less during the closed-loop period than during the control period (22.9% vs 31.7%; adjusted difference, -8.5 percentage points; 95% CI, -.9.9, -7.1; P <0.001); mean sensor glucose levels (145 ±11.8 mg/dL and 158.1 ±18.5 mg/dL, respectively; P <0.001) and mean glycated hemoglobin levels (6.6 ±0.6% and 7.0 ±0.7%) were significantly lower during the closed-loop period than during treatment with the segmented-sensor pump. There was no difference between treatment periods for percentage of time with glucose <70 mg/dL (P = 0.74). One participant had a serious adverse event (severe hypoglycemia) during their closed-loop treatment period.The authors conclude that a closed-loop system improved glycemic control in young children with type 1 diabetes.Dr Fechner has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.Type 1 diabetes is very difficult to manage in the young child. The therapeutic window for insulin is very narrow, with too much insulin resulting in hypoglycemia and too little insulin resulting in hyperglycemia. The last 5 years have seen tremendous advances in the technology available to children with type 1 diabetes. A 2019 study comparing the insulin pump to multiple daily injections showed that the insulin pump was superior to multiple daily injections. (See AAP Grand Rounds. 2019;42[1]:4.) Continuous glucose monitoring has decreased parental anxiety regarding risk of hypoglycemia and diabetic ketoacidosis;1 however, parents still are responsible for making insulin dose adjustments, and glycemic control overall is not improved.2 The results of a 2020 study of 6- to 13-year-olds with type 1 diabetes demonstrated that glucose levels were in the target range for a longer period of time in those randomized to a closed-loop system than those using a sensor-augmented pump. (See AAP Grand Rounds. 2020;44[6]:69.)3 The current researchers compared a hybrid closed-loop insulin delivery system to sensor-augmented pump therapy in younger children with type I diabetes.The strengths of the current study are the randomized, crossover design using the same algorithm with the closed-loop functionality either abled or disabled; each therapy was 16 weeks, which allowed a meaningful glycated hemoglobin to be obtained. There were no restrictions on previous episodes of hypoglycemia and diabetic ketoacidosis, and the study included a very young children with diabetes, who are more vulnerable to hypo- and hyperglycemia. Weaknesses of this study include underrepresentation of ethnic minorities and a patient population not representative of the typical type 1 diabetes population, as the average glycated hemoglobin level was 7.3% at baseline.4 Decreased patient compliance outside of the confines of a study may be reflected in poorer glucose control regardless of the insulin delivery system used.Hybrid closed-loop insulin therapy in young children with type 1 diabetes has the potential to significantly improve long-term outcomes through improved glycemic control.

Hypoglycemia in Prospective Multicenter Study of Pregnancies with Pre-Existing Type 1 Diabetes on Sensor-Augmented Pump Therapy: The LOIS-P Study.

Background: Pregnancies in type 1 diabetes are high risk, and data in the United States are limited regarding continuous glucose monitoring (CGM)-based hypoglycemia throughout pregnancy while on sensor-augmented insulin pump therapy. Materials and Methods: Pregnant women with type 1 diabetes in the LOIS-P Study (Longitudinal Observation of Insulin use and glucose Sensor metrics in Pregnant women with type 1 diabetes using continuous glucose monitors and insulin pumps) were enrolled before 17 weeks gestation at three U.S. centers and we used their personal insulin pump and a study Dexcom G6 CGM. We analyzed data of 25 pregnant women for CGM hypoglycemia based on international consensus guidelines for percentage time <63 and 54 mg/dL, hypoglycemic events and prolonged hypoglycemia events for 24-h, daytime, and overnight periods, and severe hypoglycemia (SH) episodes. Results: For a 24-h period, biweekly median percentage of time <63 mg/dL ranged from 0.8% at biweek 4-5 to 3.7% at biweek 14-15 with high variability throughout pregnancy. Median percentage of time <63 and 54 mg/dL was higher overnight than daytime (P < 0.01). Hypoglycemic events occurred throughout the pregnancy, ranged 1-4 events per 2 weeks, significantly decreased after the 20th week, and occurred predominantly during daytime (P < 0.01). For overnight period, hypoglycemia and events were more concentrated from 12 to 3 am. Seven prolonged hypoglycemia events without any associated SH occurred in four participants (16%), primarily overnight. Three participants experienced a single episode of SH. Conclusions: Our results suggest a higher overall risk of hypoglycemia throughout pregnancy during the overnight period with continued daytime risk of hypoglycemic events in pregnancies complicated by type 1 diabetes.

The effectiveness of a comprehensive diabetes program for glycemic control and adherence, and the selection of candidates for sensor-augmented insulin pump therapy

ObjectiveThis study aimed to estimate the effectiveness of a comprehensive diabetes program (CDP) in terms of glycemic control, adherence, and the selection of candidates for sensor-augmented insulin pump therapy (SAP). MethodsWe compared diabetes control before and 6 months after CDP. The program was based on disease management using a logical model dealing with the following: case management, education and coaching, nutritional assessment, and mental health. ResultsThe CDP improved glycemic control, HbA1c decreased by 0.56% (p-value=0.004; 95% CI: 0.14–0.98) and 19.1% of the patients reached the HbA1c goal without hypoglycemia. The CDP reduced by 52.4% the indication for SAP due to better glycemic control (36.4%) or non-adherence issues (63.6%); the remaining 47.6% persisted with poor glycemic control despite good adherence and were scaled to SAP. Among the 30 suitable candidates for SAP therapy, 60% did not reach the HbA1c goal and 40% had either hypoglycemic episodes (severe or persistent) or dawn phenomenon. The overall non-adherence rate was 33.3%. ConclusionsCDP optimized the selection of suitable candidates for SAP by improving glycemic control and identifying adherence issues early. These results provide evidence of the impact of the implementation of patient selection and educational protocols in the real-life setting of a highly experienced clinic.

Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up

ObjectiveTo evaluate the effectiveness and safety of sensor-augmented insulin pump therapy (SAP) in addition to a comprehensive diabetes program on glycated hemoglobin (HbA1c), severe hypoglycemia, ketoacidosis, and the hospital admission rate in patients with type 1 diabetes under real-world settings during a 2-year follow-up. MethodsThis was a retrospective real-life study comparing diabetes control before and after SAP therapy initiation. Patients ≥18 years old with type 1 diabetes were included. They were followed for 2 years with clinical assessments at months 3, 6, 12, 18, and 24. Effectiveness was estimated by difference in medians of HbA1c from baseline and at each follow-up visit. Safety was assessed by comparing the annual rates of severe hypoglycemia, hyperglycemic crisis, and hospital admission related to diabetes. Results162 patients were included, median age 32 years, women 73%). The main indication for SAP was poor metabolic control (51.2%). At 2 years HbA1c decreased from 8.4% to 7.5% (−0.9%, 95% CI: 0.5–1.2; p<0.0001), HbA1c ≤7% improved from 14.2% to 25.3% (11.1%, 95% CI: 19.7–2.5; p=0.006), and severe hypoglycemia decreased from 22.2% to 14.1% (−8.1%, 95% CI: −16.5 to 0.3; p=0.03). ConclusionsSAP therapy improved glycemic control after the third month of use and for up to 2 years of follow-up, with lower rates of hospital admission and severe hypoglycemia. More studies are needed to assess the add-on impact of education programs and technologies for diabetes care.

The effectiveness of a comprehensive diabetes program for glycemic control and adherence, and the selection of candidates for sensor-augmented insulin pump therapy

ObjectiveThis study aimed to estimate the effectiveness of a comprehensive diabetes program (CDP) in terms of glycemic control, adherence, and the selection of candidates for sensor-augmented insulin pump therapy (SAP). MethodsWe compared diabetes control before and 6 months after CDP. The program was based on disease management using a logical model dealing with the following: case management, education and coaching, nutritional assessment, and mental health. ResultsThe CDP improved glycemic control, HbA1c decreased by 0.56% (p-value=0.004; 95% CI: 0.14–0.98) and 19.1% of the patients reached the HbA1c goal without hypoglycemia. The CDP reduced by 52.4% the indication for SAP due to better glycemic control (36.4%) or non-adherence issues (63.6%); the remaining 47.6% persisted with poor glycemic control despite good adherence and were scaled to SAP. Among the 30 suitable candidates for SAP therapy, 60% did not reach the HbA1c goal and 40% had either hypoglycemic episodes (severe or persistent) or dawn phenomenon. The overall non-adherence rate was 33.3%. ConclusionsCDP optimized the selection of suitable candidates for SAP by improving glycemic control and identifying adherence issues early. These results provide evidence of the impact of the implementation of patient selection and educational protocols in the real-life setting of a highly experienced clinic.

Efficacy and safety of sensor augmented insulin pump therapy with low-glucose suspend feature in older adults: A retrospective study in Bogota, Colombia

Background and aimsThe literature has supported the efficacy and safety of insulin pump therapy in young adults diagnosed with type 1 diabetes (DM1). However, there is limited evidence in older adults with DM1 and DM2. MethodsA retrospective cohort study was conducted in patients ≥60 years-old with DM1 and DM2, who started Sensor Augmented Insulin Pump therapy with low-glucose suspend feature (SAP + LGS) at Hospital Universitario San Ignacio diabetes center in Bogotá, Colombia. Patients were evaluated between 2009 and 2019 and were treated with Paradigm VEO or Medtronic MiniMed 640 insulin pumps and continuous glucose monitoring system. Glycated hemoglobin (A1c), severe hypoglycemia and hypoglycemia unawareness were assessed at least every 3 months, and hospitalizations and ketoacidosis episodes incidence were assessed yearly. Results36 patients were analyzed, (67.36 ± 4.88 years-old) (body mass index 25.48 ± 4.61 kg/m2). The most common indications for starting SAP + LGS were hypoglycemia (58.3%), high glycemic variability (25.0%) and poor metabolic control (16.7%). 26 patients used VEO (72.2%) whereas 27.8% started 640 insulin pump. Data from 32 participants showed A1c decreased from 8.57 ± 1.73% to 7.42 ± 0.96 after a year of therapy (Mean difference −1.15%, p < 0.05); 28.12% reached A1c levels <7% and 42.85% < 7.5%. There was a significant decrease in the proportion of patients with at least one severe hypoglycemia (56.7 vs 3.3%), one or more hospitalizations (20 vs 3.3%), and hypoglycemia unawareness after the first year of follow-up (p < 0.05). ConclusionsThese results suggest that SAP + LGS is safe and effective in people 60 years or older after one year of therapy. Future randomized clinical trials are needed in the elderly.

The durability and effectiveness of sensor-augmented insulin pump therapy in pediatric and young adult patients with type 1 diabetes.

PurposeDespite the prevalent use of insulin pump therapy worldwide, few studies have been conducted among young patients with type 1 diabetes (T1D) in Korea. We investigated the durability and effectiveness of insulin pump therapy among Korean pediatric and young adult patients with T1D.MethodsThis study included 54 patients with T1D diagnosed at pediatric ages (range, 1.1–14.1 years) who initiated insulin pump therapy during 2016–2019 at Seoul National University Children's Hospital and Seoul National University Bundang Hospital. Clinical and biochemical data, including anthropometric measurements, insulin dose, and glycated hemoglobin (HbA1c) levels were obtained from T1D diagnosis to last follow-up.ResultsForty-four patients (81.5%) continued insulin pump therapy with a median pump use duration of 2.9 years (range, 0.2–3.5 years); 10 discontinued the therapy within 12 months (<1 month, n=6; 1–6 months, n=1; and 6–12 months, n=3) due to physical interferences or financial problems. Older age (≥10 years of age) and longer diabetes duration (≥2 years) at the initiation of pump therapy were associated with discontinuation (P<0.05 for both). For patients continuing pump therapy, HbA1c levels significantly decreased after 1 year of therapy (from 8.9% to 8.1%, P<0.001) without changes in the body mass index z-scores or insulin dose. Although 4 patients experienced diabetic ketoacidosis, all recovered without complications.ConclusionsInsulin pump therapy was effective in improving glycemic control in T1D patients during 12 months of treatment. Early initiation of insulin pump therapy after T1D diagnosis was helpful for continuing therapy.

Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up

ObjectiveTo evaluate the effectiveness and safety of sensor-augmented insulin pump therapy (SAP) in addition to a comprehensive diabetes program on glycated hemoglobin (HbA1c), severe hypoglycemia, ketoacidosis, and the hospital admission rate in patients with type 1 diabetes under real-world settings during a 2-year follow-up. MethodsThis was a retrospective real-life study comparing diabetes control before and after SAP therapy initiation. Patients ≥18 years old with type 1 diabetes were included. They were followed for 2 years with clinical assessments at months 3, 6, 12, 18, and 24. Effectiveness was estimated by difference in medians of HbA1c from baseline and at each follow-up visit. Safety was assessed by comparing the annual rates of severe hypoglycemia, hyperglycemic crisis, and hospital admission related to diabetes. Results162 patients were included, median age 32 years, women 73%). The main indication for SAP was poor metabolic control (51.2%). At 2 years HbA1c decreased from 8.4% to 7.5% (−0.9%, 95% CI: 0.5–1.2; p<0.0001), HbA1c ≤7% improved from 14.2% to 25.3% (11.1%, 95% CI: 19.7–2.5; p=0.006), and severe hypoglycemia decreased from 22.2% to 14.1% (−8.1%, 95% CI: −16.5 to 0.3; p=0.03). ConclusionsSAP therapy improved glycemic control after the third month of use and for up to 2 years of follow-up, with lower rates of hospital admission and severe hypoglycemia. More studies are needed to assess the add-on impact of education programs and technologies for diabetes care.

Satisfying Glycemic Control Achieved by Adding a Sodium-Glucose Co-transporter 2 Inhibitor to Sensor-Augmented Insulin Pump (MiniMed 640G) Therapy in a type 1 Diabetic Woman

Satisfying Glycemic Control Achieved by Adding a Sodium-Glucose Co-transporter 2 Inhibitor to Sensor-Augmented Insulin Pump (MiniMed 640G) Therapy in a type 1 Diabetic Woman

Predicting and Preventing Nocturnal Hypoglycemia in Type 1 Diabetes Using Big Data Analytics and Decision Theoretic Analysis.

Background: Despite new glucose sensing technologies, nocturnal hypoglycemia is still a problem for people with type 1 diabetes (T1D) as symptoms and sensor alarms may not be detected while sleeping. Accurately predicting nocturnal hypoglycemia before sleep may help minimize nighttime hypoglycemia. Methods: A support vector regression (SVR) model was trained to predict, before bedtime, the overnight minimum glucose and overnight nocturnal hypoglycemia for people with T1D. The algorithm was trained on continuous glucose measurements and insulin data collected from 124 people (22,804 valid nights of data) with T1D. The minimum glucose threshold for announcing nocturnal hypoglycemia risk was derived by applying a decision theoretic criterion to maximize expected net benefit. Accuracy was evaluated on a validation set from 10 people with T1D during a 4-week trial under free-living sensor-augmented insulin-pump therapy. The primary outcome measures were sensitivity and specificity of prediction, the correlation between predicted and actual minimum nocturnal glucose, and root-mean-square error. The impact of using the algorithm to prevent nocturnal hypoglycemia is shown in-silico. Results: The algorithm predicted 94.1% of nocturnal hypoglycemia events (<3.9 mmol/L, 95% confidence interval [CI], 71.3-99.9) with an area under the receiver operating characteristic curve of 0.86 (95% CI, 0.75-0.98). Correlation between actual and predicted minimum glucose was high (R = 0.71, P < 0.001). In-silico simulations showed that the algorithm could reduce nocturnal hypoglycemia by 77.0% (P = 0.006) without impacting time in target range (3.9-10 mmol/L). Conclusion: An SVR model trained on a big data set and optimized using decision theoretic criterion can accurately predict at bedtime if overnight nocturnal hypoglycemia will occur and may help reduce nocturnal hypoglycemia.

Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial

Automated closed-loop control (CLC), known as the "artificial pancreas" is emerging as a treatment option for Type 1 Diabetes (T1D), generally superior to sensor-augmented insulin pump (SAP) treatment. It is postulated that evening-night (E-N) CLC may account for most of the benefits of 24-7 CLC; however, a direct comparison has not been done. In this trial (NCT02679287), adults with T1D were randomised 1:1 to two groups, which followed different sequences of four 8-week sessions, resulting in two crossover designs comparing SAP vs E-N CLC and E-N CLC vs 24-7 CLC, respectively. Eligibility: T1D for at least 1 year, using an insulin pump for at least six months, ages 18 years or older. Primary hypothesis: E-N CLC compared to SAP will decrease percent time <70mg/dL (3.9mmol/L) measured by continuous glucose monitoring (CGM) without deterioration in HbA1c. Secondary Hypotheses: 24-7 CLC compared to SAP will increase CGM-measured time in target range (TIR, 70-180mg/dL; 3.9-10mmol/L) and will reduce glucose variability during the day. Ninety-three participants were randomised and 80 were included in the analysis, ages 18-69 years; HbA1c levels 5.4-10.6%; 66% female. Compared to SAP, E-N CLC reduced overall time <70mg/dL from 4.0% to 2.2% () resulting in an absolute difference of 1.8% (95%CI: 1.2-2.4%), p<0.0001. This was accompanied by overall reduction in HbA1c from 7.4% at baseline to 7.1% at the end of study, resulting in an absolute difference of 0.3% (95% CI: 0.1-0.4%), p<0.0001. There were 5 severe hypoglycaemia adverse events attributed to user-directed boluses without malfunction of the investigational device, and no diabetic ketoacidosis events. In type 1 diabetes, evening-night closed-loop control was superior to sensor-augmented pump therapy, achieving most of the glycaemic benefits of 24-7 closed-loop.

Cost-Effectiveness of Sensor-Augmented Insulin Pump Therapy Versus Continuous Insulin Infusion in Patients with Type 1 Diabetes in Turkey.

Background and Aims: Sensor-augmented pump therapy (SAP) combines continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII). SAP is costlier than CSII but provides additional clinical benefits relative to CSII alone. A long-term cost-effectiveness analysis was performed to determine whether SAP is cost-effective relative to CSII in patients with type 1 diabetes (T1D) in Turkey. Methods: Analyses were performed in two different patient cohorts, one with poor glycemic control at baseline (mean glycated hemoglobin 9.0% [75 mmol/mol]) and a second cohort considered to be at increased risk of hypoglycemic events. Clinical input data and direct medical costs were sourced from published literature. The analysis was performed from a third-party payer perspective over patient lifetimes and future costs and clinical outcomes were discounted at 3.5% per annum. Results: In both patient cohorts, SAP was associated with a gain in quality-adjusted life expectancy but higher costs relative to CSII (incremental gain of 1.40 quality-adjusted life years [QALYs] in patients with poor baseline glycemic control and 1.73 QALYs in patients at increased risk of hypoglycemic events). Incremental cost-effectiveness ratios for SAP versus CSII were TRY 76,971 (EUR 11,612) per QALY gained for patients with poor baseline glycemic control and TRY 69,534 (EUR 10,490) per QALY gained for patients at increased risk for hypoglycemia. Conclusions: SAP is associated with improved long-term clinical outcomes versus CSII, and in Turkey, SAP is likely to represent good value for money compared with CSII in T1D patients with poor glycemic control and/or with frequent severe hypoglycemic events.