Method Of Insulin Administration Research Articles

The Dilemma of Insulin Delivery into the Brain: A Comprehensive Review.

Insulin is a peptide hormone that is essential for regulating body homeostasis. Furthermore, it is involved in various neurological functions such as memory, behaviors, and cognition. The ubiquitous distribution of insulin receptors on various brain cells, such as neurons, microglia, astrocytes, and oligodendrocytes, and their differential localization across various brain regions, including the hippocampus, hypothalamus, and olfactory bulb, collectively underscore the crucial involvement of insulin in the modulation of cerebral functions. Along with ageing, in some pathological conditions such as diabetes and brain insulin resistance, the need for exogenous insulin is felt to compensate for insulin deficiency. In these cases, the biggest obstacle to the delivery of insulin to the brain is the blood-brain barrier (a physical barrier consisting of endothelial cells with tight junctions), which prevents the direct entry of most substances possessing high molecular weight, like insulin, into the brain. Therefore, different delivery methods have been proposed by researchers for insulin delivery that directly or indirectly cause the transfer of insulin to the brain. Some of these methods lack high efficiency and cause many side effects for the patient. In this regard, many new technologies have come to the aid of researchers and have introduced more effective delivery strategies, including the use of nanocarriers. Despite the promising outcomes demonstrated in the experimental models, the utilization of these techniques in human studies remains at a nascent stage and necessitates further comprehensive investigation. This review article aims to examine the diverse methods of insulin administration to the brain by gathering extensive information on insulin and its obstacles to brain delivery.

Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, open-label, randomised controlled trial

Advanced hybrid closed loop (AHCL) therapy can improve glycaemic control in pregnant women with type 1 diabetes. However, data are needed on the efficacy and safety of AHCL systems as these systems, such as the MiniMed 780G, are not currently approved for use in pregnant women. We aimed to investigate whether the MiniMed 780G can improve glycaemic control with less hypoglycaemia in pregnant women with type 1 diabetes. CRISTAL was a double-arm, parallel-group, open-label, randomised controlled trial conducted in secondary and tertiary care specialist endocrinology centres at 12 hospitals (11 in Belgium and one in the Netherlands). Pregnant women aged 18-45 years with type 1 diabetes were randomly assigned (1:1) to AHCL therapy (MiniMed 780G) or standard insulin therapy (standard of care) at a median of 10·1 (IQR 8·6-11·6) weeks of gestation. Randomisation was done centrally with minimisation dependent on baseline HbA1c, insulin administration method, and centre. Participants and study teams were not masked to group allocation. The primary outcome was proportion of time spent in the pregnancy-specific target glucose range (3·5-7·8 mmol/L), measured by continuous glucose monitoring (CGM) at 14-17 weeks, 20-23 weeks, 26-29 weeks, and 33-36 weeks. Key secondary outcomes were overnight time in target range, and time below glucose range (<3·5 mmol/L) overall and overnight. Analyses were conducted on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov (NCT04520971). Between Jan 15, 2021 and Sept 30, 2022, 101 participants were screened, and 95 were randomly assigned to AHCL therapy (n=46) or standard insulin therapy (n=49). 43 patients assigned to AHCL therapy and 46 assigned to standard insulin therapy completed the study. At baseline, 91 (95·8%) participants used insulin pumps, and the mean HbA1c was 6·5% (SD 0·6). The mean proportion of time spent in the target range (averaged over four time periods) was 66·5% (SD 10·0) in the AHCL therapy group compared with 63·2% (12·4) in the standard insulin therapy group (adjusted mean difference 1·88 percentage points [95% CI -0·82 to 4·58], p=0·17). Overnight time in the target range was higher (adjusted mean difference 6·58 percentage points [95% CI 2·31 to 10·85], p=0·0026), and time below range overall (adjusted mean difference -1·34 percentage points [95% CI, -2·19 to -0·49], p=0·0020) and overnight (adjusted mean difference -1·86 percentage points [95% CI -2·90 to -0·81], p=0·0005) were lower with AHCL therapy than with standard insulin therapy. Participants assigned to AHCL therapy reported higher treatment satisfaction. No unanticipated safety events occurred with AHCL therapy. In pregnant women starting with tighter glycaemic control, AHCL therapy did not improve overall time in target range but improved overnight time in target range, reduced time below range, and improved treatment satisfaction. These data suggest that the MiniMed 780G can be safely used in pregnancy and provides some additional benefits compared with standard insulin therapy; however, it will be important to refine the algorithm to better align with pregnancy requirements. Diabetes Liga Research Fund and Medtronic.

Role of nutritional therapy on dietary habits and glycemic control in insulin-treated kidney transplant patients with diabetes

AimsTo evaluate the effect of nutritional therapy on glycemic compensation and key cardio-renal risk markers in patients with diabetes and kidney transplant, on insulin treatment by Multiple Daily Injection (MDI) or Continuous Subcutaneous Insulin Infusion (CSII). Methods34 patients with diabetes on insulin treatment and kidney transplant recipients were enrolled;12 participated in the structured nutritional program (intervention group), 22 patients (control group) did not receive nutritional protocol. Both groups were then divided into subgroups according to the method of insulin administration (MDI and CSII). ResultsStatistically significant reduction in fasting blood glucose values, glycosylated hemoglobin (HbA1c) and glycosuria were observed in both groups at the end of the study. The intervention group, significantly reduced total cholesterolemia and the glycemic index, together with reduced dietary intake of lipids, cholesterol, soluble carbohydrates and increased consumption of carbohydrates and fiber. These improvements were even more pronounced in patients treated with CSII. ConclusionsA proper nutritional approach optimize glycometabolic outcomes and contribute significantly to the reduction of the major cardiovascular risk factors in renal transplant patients.

Differences in Glycemic Control for Inpatients with Type 1 Diabetes on Insulin Pump Versus Subcutaneous Insulin Therapy.

Inpatient use of insulin pump therapy has been increasing due to greater availability of this technology, however there is a paucity of research that investigates glycemic control of inpatient insulin pump users. To compare the glycemic control of hospitalized patients with type 1 diabetes (T1D) who used insulin pump vs. multiple daily injections(MDI). Retrospective chart review. Patients with T1D who were hospitalized between January 1, 2017, and December 31, 2019, in an academic medical center in the New York metropolitan area. Patients were categorized into three groups based on their method of insulin administration: "pump only" groupused insulin pump exclusively, "MDI only" group used MDI only, and "intermittent pump" group used a combination of both methods. The primary endpoints are mean blood glucose, rates of hypoglycemic events (blood glucose < 70mg/dL), and rates of hyperglycemic events (blood glucose > 250mg/dL).Separate multivariable Poisson regressions were performed to determine the association between the type of insulin administration and rate outcomes (i.e., rate of hypoglycemic events and rate of hyperglycemic events). The study included 78 patients with a mean age of 51, who were mostly male (54%), and white (72%). The average proportion of glucose measurements that were hyperglycemic for the "pump only", "MDI only", and "intermittent pump" groups were 0.11 (SD = 0.11), 0.25 (SD = 0.19), and 0.24 (SD = 0.25), respectively. The "pump only" group has a significantly lower proportion of hyperglycemic events as compared to the "MDI only" group (p = 0.0227). In this sample, patients who exclusively used their insulin pump while inpatient had a lower rate of hyperglycemic events than patients who used MDI only; suggesting that select patients can safely continue their insulin pump therapy in the inpatient setting.

Current barriers to initiating insulin therapy in individuals with type 2 diabetes.

Insulin is an essential drug in the treatment of diabetes, often necessary for managing hyperglycemia in type 2 diabetes mellitus (T2DM). It should be considered in cases of severe hyperglycemia requiring hospitalization, after the failure of other treatments, in advanced chronic kidney disease, liver cirrhosis, post-transplant diabetes, or during pregnancy. Moreover, in specific patient subgroups, early initiation of insulin is crucial for hyperglycemia control and prevention of chronic complications. Clinical guidelines recommend initiating insulin when other treatments fail, although there are barriers that may delay its initiation. The timing of initiation depends on individual patient characteristics. Typically, insulinization starts by adding basal insulin to the patient's existing treatment and, if necessary, progresses by gradually introducing prandial insulin. Several barriers have been identified that hinder the initiation of insulin, including fear of hypoglycemia, lack of adherence, the need for glucose monitoring, the injection method of insulin administration, social rejection associated with the stigma of injections, weight gain, a sense of therapeutic failure at initiation, lack of experience among some healthcare professionals, and the delayed and reactive positioning of insulin in recent clinical guidelines. These barriers contribute, among other factors, to therapeutic inertia in initiating and intensifying insulin treatment and to patients' non-adherence. In this context, the development of once-weekly insulin formulations could improve initial acceptance, adherence, treatment satisfaction, and consequently, the quality of life for patients. Currently, two once-weekly basal insulins, insulin icodec and basal insulin BIF, which are in different stages of clinical development, may help. Their longer half-life translates to lower variability and reduced risk of hypoglycemia. This review addresses the need for insulin in T2DM, its positioning in clinical guidelines under specific circumstances, the current barriers to initiating and intensifying insulin treatment, and the potential role of once-weekly insulin formulations as a potential solution to facilitate timely initiation of insulinization, which would reduce therapeutic inertia and achieve better early control in people with T2DM.

Switching to a Minimed 780G closed-loop hybrid system: Real-life experience in a center of Latin America

IntroductionInsulin pumps serve as alternative insulin delivery methods with physiological similarity to the normal pancreas. The MiniMed 780G device is an advanced closed-loop hybrid system. Recent real-life studies have allowed reaching a higher percentage of time in range (TIR) (70 to 180 mg/dL). Being an emerging technology, it is of the utmost value to report on the early experience of use of this device. MethodsThis was an observational, descriptive, cross-sectional study that included patients older than 18 years with types 1 diabetes mellitus and other types switched to a Medtronic 780G insulin pump. Baseline clinical and glycemic control variables and those after 4 weeks of using the SmartGuard mode were evaluated. ResultsThirty-nine patients (mean age, 33 years) were analyzed, 95 % of whom had type 1 diabetes with an average disease duration of 17 years. The values for time below range (TBR) <54 mg/dL, TBR <70 mg/dL, TIR, time above range (TAR) >180 mg/dL, and TAR >250 mg/dL were 0 %, 3 %, 72 %, 21 %, and 3 %, respectively, at baseline and 1 %, 2 %, 79 %, 14 %, and 2 %, respectively, after the intervention. The changes in TIR varied based on prior therapy: multiple daily injections of insulin, 13 % improvement; MiniMed Paradigm Veo/MiniMed 640G, 6 % improvement; and MiniMed 670G, −4 % improvement. ConclusionIn conclusion, the application of a hybrid closed-loop system allowed for better glycemic control based on international standards. The average percentage improvement in TIR was lower than that in other studies and was dependent on the previous method of insulin administration, achieving lower performance with the migration from recent technologies such as the Minimed 670G.

Nose-to-brain delivery of insulin nanoparticles for diabetes management: A review

Hyperglycemia and the onset of insulin resistance or deficiency, or both, are the hallmarks of the group of diseases known as diabetes. Ultimately, insulin subcutaneous injection is the most effective treatment for diabetic patients. However, most patients must self-administer insulin at least twice daily for the rest of their lives, as this form of administration is frequently uncomfortable and inconvenient. Infections, insulin precipitation, lipoatrophy, or lipohypertrophy are commonly observed at the injection site. To date, nasal, pulmonary, and oral methods of insulin administration have been explored. Although insulin stimulation is the ideal method for diabetic patients, there are several obstacles to overcome, such as rapid insulin degradation in the stomach and limited oral bioavailability. Various strategies have been approved to improve these parameters, including the use of enzyme inhibitors, mucoadhesive polymeric agents, absorption-enhancing agents, and chemical modifications. Insulin-loaded nanocarriers can bypass numerous physiological limitations. The current review discusses the approach of nanotechnology in nose-to-brain delivery of nanoparticles for diabetes management.

Association between insulin administration method and six-month neurological outcome in survivors of out-of-hospital cardiac arrest who underwent targeted temperature management.

We investigated the association of insulin administration method with the achievement of mean glucose ≤ 180 mg/dL and neurological outcomes in out-of-hospital cardiac arrest (OHCA) survivors who had hyperglycemia after the return of spontaneous circulation. From a multicenter prospective registry, we extracted the data of adult OHCA survivors who underwent targeted temperature management (TTM) between 2015 and 2018. Blood glucose levels every 4 h after initiating TTM were obtained for 72 h. We divided insulin administration methods into three categories: subcutaneous (SQI), intravenous bolus (IBI), and continuous intravenous (CII). We calculated the mean glucose and standard deviation (SD) of glucose. The primary outcome was the achievement of mean glucose ≤ 180 mg/dL. The secondary outcomes were the 6-month neurological outcome based on the Cerebral Performance Category (CPC) scale (good, CPC 1-2; poor, CPC 3-5), mean glucose, and SD of glucose. Of the 549 patients, 296 (53.9%) achieved mean glucose ≤ 180 mg/dL, and 438 (79.8%) had poor neurological outcomes, 134 (24.4%), 132 (24.0), and 283 (51.5%) were in the SQI, IBI, and CII groups, respectively. The SQI (adjusted odds ratio [aOR], 0.848; 95% confidence intervals [CIs], 0.493-1.461) and IBI (aOR, 0.673; 95% CIs, 0.415-1.091) groups were not associated with mean glucose ≤ 180 mg/dL and the SQI (aOR, 0.660; 95% CIs, 0.335-1.301) and IBI (aOR, 1.757; 95% CIs, 0.867-3.560) groups were not associated with poor neurological outcomes compared to the CII group. The CII (168 mg/dL [147-202]) group had the lowest mean glucose than the SQI (181 mg/dL [156-218]) and IBI (184 mg/dL [162-216]) groups. The CII (45.0[33.9-63.5]) group had a lower SD of glucose than the IBI (50.8 [39.1-72.0]) group. The insulin administration method was not associated with achieving mean glucose ≤ 180 mg/dL and 6-month neurological outcomes.

Prevalence of hypoglycemic conditions in adolescents with type 1 diabetes mellitus in real clinical practice

BACKGROUND. Hypoglycemia and fear of hypoglycemia remain critical problems in the treatment of adolescents with type 1 diabetes mellitus (DM1) and are factors limiting proper control of glycemia and preventing the achievement of metabolic compensation of the disease. The use of pump insulin therapy involves the prevention of hypoglycemic conditions.AIM. To analyze the frequency and duration of hypoglycemia episodes, their effect on the metabolic compensation of the disease in adolescents with type 1 diabetes mellitus (DM1) in real clinical practice, depending on the mode/method of insulin administration.MATERIALS AND METHODS. The study involved 117 adolescents with DM1 aged 12 to 19 years (average age 15.5 years). 37 adolescents received therapy by continuous subcutaneous insulin infusion (CSII); 80 adolescents received therapy by multiple insulin injections (MII). The level of glycated hemoglobin (HbA1c) was determined for all adolescents, and its main indicators were evaluated using a 6 days continuous glucose monitoring (CGM) by the «blind» method of a professional system with an iPro 2 sensor (Medtronic MiniMed, USA).RESULTS. Episodes of a decrease in glucose levels &lt;3,9 mmol/l were recorded in 87% of patients (n=102), 63% (n=74) showed a decrease in glucose levels &lt;3,0 mmol/l. Episodes decrease in glucose levels &lt;3,9 mmol/l at night were recorded in 68% of patients (n=80), and with glucose levels &lt;3,9 mmol/l in 46% (n=54). The frequency of episodes of glucose lowering &lt;3,9 mmol/l had no statistically significant differences depending on the methods of insulin administration (by continuous subcutaneous insulin infusion or multiple insulin injections), however, they are more common in adolescents with HbA1c &lt;7,0% (p=0,03). The median time spent by patients in the range of &lt;3,9 mmol/l was 5% per day, and a longer time in this range was observed in patients with HbA1c &lt;7,0% (p=0,006). The median time in the range of &lt;3,0 mmol/l was 1% per day and had no significant differences depending on the level of HbA1c (p=0,559). There were also no significant differences depending on the groups using CSII and MII (p=0,640 and p=0,250).CONCLUSION. Episodes of glucose reduction in the range of &lt;3,9 mmol/l according to CGM data are more common in adolescents with HbA1c target values, regardless of the method of insulin administration. Significantly more time in range of &lt;3,9 mmol/l is spent by adolescents with target values of HbA1c i.е. &lt;7,0% compared with HbA1c ≥7,0%, however, in both groups, a large number of patients had time in the range below the target level was higher than recommended values.

Evaluation of Lipohypertrophy in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injections or Continuous Subcutaneous Insulin Infusion

ObjectiveTo determine lipohypertrophy (LH) in patients with type 1 diabetes mellitus (T1DM) on multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII) and to reveal the factors associated with the development and severity of LH. MethodsSixty-six patients with T1DM treated with MDII (n = 35, 53%) or CSII (n = 31, 47%) for at least 1 year were included. LH localizations were detected with palpation and ultrasonography (USG). ResultsThe LH detection rate with USG was significantly higher than that by palpation in the whole group (P < .001). The LH was detected with USG in 30 (85.7%) patients in the MDII group and 22 (71.0%) patients in the CSII group (P = .144). Advanced LH was detected in 13 (37.1%) of the patients treated with MDII and in 3 (9.7%) of the patients treated with CSII. LH was more severe in the MDII group than in the CSII group (P = .013). Diabetes duration and length of infusion set use were significantly longer and body mass index, hypoglycemia, and complication rates were higher in patients with LH than those in patients without LH (P < .05). A positive correlation was found between LH severity and HbA1C and insulin dose (P < .05, for both). MDII as insulin administration method, incorrect rotation, and a history of ketosis were found to be the most related factors with LH severity in a multiple linear regression analysis (P < .05). ConclusionUSG might be an effective approach for detecting and evaluating the severity of LH. MDII might cause more severe LH than CSII in patients with T1DM. In this study, LH was found to be associated mostly with incorrect rotation technique and a history of ketosis.

Impact of the COVID-19 Pandemic on the Physical Activity Profile and Glycemic Control Among Qatari Adults With Type 1 Diabetes: Effect of Vaccination Status.

ObjectiveTo investigate the impact of COVID-19, as an influent barrier on physical activity (PA) patterns and glycemic control in Qatari adults with type 1 diabetes (T1D). As the COVID-19 vaccine may have a potential impact on an individual's lifestyle, we also considered this parameter.MethodsPhysical activity level, the exercise barriers (BAPAD1), anthropometric characteristics, the method of insulin administration, and the last glycated hemoglobin in % were completed by 102 Qatari adults with T1D. Moreover, all patients were asked whether they had “been vaccinated” or had a “fear of being infected by COVID-19”.ResultsFor the unvaccinated group, weight, BMI and HbA1c (%) were significantly higher than those of vaccinated group (p < 0.01) and engaged in less moderate-to-vigorous PA (MVPA) (p < 0.01) per week and had less time in vigorous PA (VPA) (p < 0.01). A significant association between VPA levels and BMI (β = −0.36, p = 0.02) and HbA1C (%) (β = −0.22; p = 0.03) was reported, and “being vaccinated” was significantly associated with MVPA (β = 0.15; p = 0.021) and VPA (β = 0.28; p = 0.032). A higher “Fear of being infected by COVID-19” score was negatively correlated with reduced PA profiles (R2 = −0.71 for MVPA; R2 = −0.69 for VPA, p < 0.01, respectively).ConclusionPracticing VPA during the COVID-19 pandemic confer many health benefits for Qatari individual with T1D. As the “Fear of being affected by COVID-19” appeared as a potential barrier to PA practices this latter e.g. PA, could likely not be achieved without the participants being vaccinated.

RECENT APPROACHES IN GLUCOSE RESPONSIVE INSULIN DELIVERY SYSTEM

Diabetes mellitus is a chronic medical condition currently affecting 382 million people across the globe, caused due to increased blood glucose levels due to less insulin production or insulin resistance. Subcutaneous insulin administration for diabetes is the only most accepted therapy for maintaining blood glucose levels in diabetic patients. Many patients with advanced type II diabetes mellitus need to regularly monitor their blood glucose level to keep their blood glucose level in the target range. However long-term insulin therapy through an invasive route of administration causes problems with patient compliance and a sudden decrease in blood glucose levels. An artificial closed-loop insulin release system that mimics the glucose-responsive insulin secretion by β-cells of pancreas is one of the ways to overcome the problem faced with the conventional method of insulin administration. Many polymeric formulations showed an improved glucose-responsive release of insulin when incorporated with glucose-responsive catalysts such as glucose oxidase, phenylboronic acid, and glucose binding proteins, the release rate can be controlled by optimizing the concentration of glucose-responsive catalysts. This article is been focused on different mechanisms of glucose-responsive release by incorporation with glucose-responsive catalysts.

Comparison between insulin delivery methods: subcutaneous, inhaled, oral, and buccal

Diabetes mellitus is a complex and chronic metabolic disorder characterized by hyperglycemia. Part of the treatment for this condition is the administration of insulin, a protein that directly influences blood glucose levels. It is traditionally administered parenterally; however, new alternative ways for its application seek greater efficiency and less invasiveness. The objective of this article is to compare the different methods of insulin administration, taking into account new technologies. This review article provides an overview of diabetes and insulin, highlights the advantages and disadvantages of insulin delivery methods (subcutaneous, inhaled, oral, and buccal), and shows the new technologies that include biotechnological applications.

Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial

People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1). We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA1c), time in range (sensor glucose 3·9-10·0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600. Between Jan 29 and Jul 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59·6% vs 51·9%; mean difference 6·85 percentage points [95% CI 4·36-9·34]; p<0·0001). After 6 months HbA1c was lower (7·1% vs 7·4%; p<0·0001), as was time <3·0 mmol/L (0·47% vs 0·84%; p=0·0070), and Hypoglycaemia Fear Survey version II worry subscale score (15·4 vs 18·0; p=0·0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0·0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users. In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes. Dexcom.

879-P: Positive Impact of Use of Continuous Glucose Monitoring on Glycemic Outcomes in Young Adults with Type 1 Diabetes, in Adult Clinical Setting, Independent of Insulin Administration Method

Introduction: Young adults (YA) with type 1 diabetes (T1D) are at risk of poor glycemic control. Use of continuous glucose monitoring (CGM) has been shown to improve glucose control. However, real-world data on the impact of CGM use on glucose control in YA is limited. Methods: We analyzed data from electronic medical records collected across 2018 from a tertiary adult clinic of YA patients age 18- 30 yrs with T1D. A1C and insulin administration methods defined as sliding scale (SS), multiple daily injection while carbohydrate counting (MDI), or via pump therapy (Pump) were collected along with CGM use. Results: Data from 891 patients (mean age 26±3, T1D duration 12±7 years, 52% female, average A1C 7.9%±1.5) were analyzed. Twelve % (n= 110) were on SS; 37% (n=331) on MDI, and 51% (n= 450) on pump therapy; mean age of all 3 groups was 26 ± 3yrs. Use of CGM was recorded in 32% of patients on SS, while use of CGM was recorded in 46% and 66% of patients using MDI and pump, respectively. A1C differed between CGM users and non-users in each subgroup. Conclusion: With increasing complexity of insulin regimen, CGM use rises. However, independent of insulin administration method, CGM use was associated with lower A1C. These findings highlight the potential benefit of CGM use, in YA with T1D in adult clinic settings. Disclosure E. Toschi: None. R.A. Gabbay: Advisory Panel; Self; FormHealth, Health Reveal, Lark, Onduo, Vida Health. A. Clift: None. M. Bennetti: None. A. Atakov-Castillo: None.

Association between type 1 diabetes and female sexual dysfunction

BackgroundThis study aims to evaluate: 1) the prevalence of Female Sexual Dysfunction (FSD) in women affected by type 1 Diabetes Mellitus (DM) and the control group; 2) the correlation between duration of DM, HbA1C levels and sexual life quality; 3) the relationship between different methods of insulin administration and sexual life quality; 4) the correlation between FSD and diabetes complications.MethodsWe selected 33 women with type 1 DM and 39 healthy women as controls. Each participant underwent a detailed medical history and physical examination and completed the 6-item Female Sexual Function Index questionnaire (FSFI-6). In patients affected by type 1 DM, the different methods of insulin administration (Multi Drug Injection - MDI or Continuous Subcutaneous Insulin Infusion - CSII) and the presence of DM complications were also investigated.ResultsThe prevalence of FSD (total score ≤ 19) was significantly higher in the type 1 DM group than in the control group (12/33, 36.4% and 2/39, 5.2%, respectively; p = 0.010). No statistically significant differences were found regarding FSD according to the presence of complications, method of insulin administration or previous pregnancies.ConclusionsThis study underlined that FSD is higher in women affected by type 1 DM than in healthy controls. This could be due to the diabetic neuropathy/angiopathy and the type of insulin administration. Therefore, it is important to investigate FSD in diabetic women, as well as erectile dysfunction in diabetic men.

Factors Associated with Acute Complications among Individuals with Type 1 Diabetes in China: The 3C Study

ABSTRACTBackground: To identify the sociodemographic and clinical characteristics related to the occurrence of diabetic ketoacidosis (DKA) and frequent hypoglycemia in children, adolescents and adults with type 1 diabetes in China.Methods: The 3C Study was an epidemiological study that recruited 849 type 1 diabetes patients aged 0–78 years in Beijing and Shantou, China. Separate logistic regression models were used to evaluate the association of sociodemographic and clinical factors with the occurrence of DKA in the past 12 months or frequent hypoglycemia (≥5 episodes) in the past 7 days.Results: Children and adolescents were significantly more likely to have DKA in the past 12 months compared to adults: odds ratio (OR) and (95% confidence interval [CI]), 4.67 (1.90, 11.52) for <13 years and 4.00 (1.59, 10.10) for 13 to <19 years. Underweight participants were also more likely to have DKA relative to normal weight participants: OR (95% CI), 6.87 (2.64, 17.87). Children and participants who did not receive diabetes education in the past 12 months were more likely to have frequent hypoglycemia: OR (95% CI), 2.95 (1.23, 7.06) and 7.67 (1.77, 13.2), respectively. Participants who reported self-monitoring of blood glucose ≤2 times/week (ref: 7 times/week) and participants who had higher HbA1c levels were less likely to have frequent hypoglycemia: OR (95% CI), 0.14 (0.03, 0.64) and 0.78 (0.63, 0.96), respectively. Gender, family income, parent education, health insurance coverage, diabetes duration, and insulin administration method were not significantly associated with DKA or frequent hypoglycemia in this sample.Conclusions: Children, adolescents and underweight individuals with type 1 diabetes in China were more likely to report DKA, and children, individuals without adequate diabetes education, and those with lower HbA1c levels were more likely to have frequent hypoglycemia. These patients should be targeted for preventive interventions.

906-P: Safety and Efficacy of Continuous Glucose Monitoring at an ADA Camp

Personal use of Continuous Glucose Monitor (CGM) technology has increased as a tool to optimize glycemic control. CGM use at ADA camps has also risen over the past few years, however, some campers opt not to use their home CGM at camp as finger stick blood sugars were standard for monitoring glycemic control per camp protocols. At camp, kids are exposed to various levels of activity and different foods leading to variable insulin requirements compared to home regimens. This, in turn, could increase the number of potentially dangerous hypoglycemic episodes at camp if blood glucoses (BG) are not tightly monitored. The safety and efficacy of CGM in an ADA camp setting has not yet been published. This retrospective case-control quality review was performed on camper data from ADA Camp MIDICHA 2017 summer session. It was hypothesized that campers using CGM would have fewer severe glucose excursions (hypo- or hyperglycemia) compared to campers not using CGM. Of the 483 campers, 36 campers used CGM at camp. Another 36 campers (age/gender matched) who did not use CGM were identified as controls. Campers were further matched based on insulin administration method (pump vs. injections) and cabin (to reduce activity variability). BG data including average BG levels, hypoglycemic events (BG &amp;lt;50, &amp;lt;70, &amp;lt;80 mg/dL), and hyperglycemic events (BG &amp;gt;250, &amp;gt;300, and &amp;gt;400 mg/dL) were collected and analyzed. There was no significant difference in average BG levels of campers using CGM and those not using CGM (BG=179.6 vs. 178.53 mg/dL; p=0.8832). Binary logistics regressions were used to generate odds ratios for glycemic event data. Campers using CGM had a 74% lower relative risk of having at least one severe hypoglycemic episode (BG &amp;lt;50) during their week at camp compared to controls (14% vs. 38%; OR: 0.26 (95% CI: 0.09, 0.73); P = 0.0012). No significant differences were noted in hyperglycemia frequency amongst campers using CGM and controls. Therefore, the use of CGM should be encouraged in the camp setting to reduce the incidence of severe hypoglycemia. Disclosure A. Sosnowski: None. L. Schmeltz: Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Eli Lilly and Company, Merck &amp; Co., Inc., Novo Nordisk Inc.

92-LB: Real-World, Chart Review Study to Determine the Effectiveness of FreeStyle Libre Flash Glucose Monitoring System, in Adults with Type 2 Diabetes in France

This retrospective, real-world, chart review study determined the effectiveness of the FreeStyle Libre Flash Glucose Monitoring SystemTM on HbA1c when used by adults with type 2 diabetes (T2DM) as their standard of care in a real-world setting for between 3 months to 6 months. The study population included adults on a basal-bolus insulin regimen for at least 1 year, with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol), who had been prescribed and using FreeStyle Libre regularly for at least 3 months. Pregnant patients were excluded, as were patients on dialysis. A total of 88 records from insulin using patients with T2DM from 6 hospital sites in France were included in this chart review. On average, HbA1c was 9.0±0.9% (74.7±9.7 mmol/mol), prior to FreeStyle Libre use, age was 64.4±10.6 years, BMI was 32.9±5.5 kg/m2 and average duration of insulin use 9.9±6.4 years (mean±SD), 24.1% were CSII users, 58.0% of patients were on oral antidiabetic medications (metformin, SU or DPP-4) in addition to basal-bolus and 56.8% were male. CVD, renal and retinopathy complications were reported by 40.9%, 37.5% and 37.5% of patients, respectively. HbA1c results were recorded between 91 to 183 days from the start of use of FreeStyle Libre, between May 2017 and July 2018. To minimise selection bias records were selected on a systematic basis. After at least 3 months of using FreeStyle Libre, HbA1c (primary outcome) was significantly reduced by 0.8±1.1% (mean±SD); p&amp;lt;0.0001. Sub-group analysis by insulin administration method showed HbA1c significantly reduced for both people using multiple daily injections and CSII; with reductions of 0.7±1.1%, p&amp;lt;0.0001 and 1.0±1.0% (mean±SD), p=0.0001, respectively. This real-world, chart review study concluded that people with T2DM on insulin therapy, using FreeStyle Libre for between 3 to 6 months significantly reduced HbA1c. Disclosure H. Hanaire: Research Support; Self; Abbott, Eli Lilly and Company, LifeScan, Inc., Novo Nordisk A/S. Other Relationship; Self; Eli Lilly and Company, Novo Nordisk A/S. P.Y. Benhamou: Board Member; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi. Consultant; Self; Abbott. C. Bures: Employee; Self; Abbott Laboratories. Employee; Spouse/Partner; Alere Inc. S. Favre: None. S. Fendri: None. M. Joubert: Board Member; Self; Abbott, Air Liquide, AstraZeneca, Lilly Diabetes, Medtronic, Novo Nordisk A/S. Consultant; Self; Voluntis France. Research Support; Self; Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Amgen Inc., LifeScan, Inc., Merck Sharp &amp; Dohme Corp., Sanofi.

Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus.

AimsTo quantitatively describe the relationship between dapagliflozin systemic exposure and HbA1c response among patients with type 1 diabetes mellitus (T1DM) and assess the potential impact of covariate effects.Materials and MethodsIndividual longitudinal HbA1c data from two phase 3 studies in patients with T1DM (24‐week treatment with once‐daily dapagliflozin 5 or 10 mg or placebo, with adjustable insulin) were analyzed using a non‐linear mixed effect modeling approach. Area under the concentration curve was used to measure dapagliflozin systemic exposure. Baseline HbA1c, estimated glomerular filtration rate, reduction in total insulin dose, baseline glucose concentrations, age, sex, race (Asian vs. non‐Asian), and insulin administration method (multiple daily injections vs. insulin pump) were assessed as covariates.ResultsA maximum effect (Emax) model identified a positive exposure–response relationship. Model‐predicted placebo‐corrected HbA1c reductions after 24 weeks for dapagliflozin 5‐ and 10‐mg doses were − 0.42% [95% confidence interval (CI) −0.47 to −0.36) and − 0.45% (95% CI −0.50 to −0.40), respectively; baseline HbA1c was ~8.4%. This was in good agreement with actual observations from both studies. Baseline HbA1c was a significant covariate: patients with higher baseline HbA1c were predicted to have greater HbA1c reductions.ConclusionsThe relationship between dapagliflozin systemic exposure and HbA1c response was successfully described in patients with T1DM. None of the tested covariates affected the efficacy of dapagliflozin to a clinically relevant extent. Therefore, no dose adjustment of dapagliflozin is required in patients with T1DM based on the tested covariates. ClinicalTrials.gov, NCT02268214; NCT02460978.