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Objective: To evaluate whether diabetes treatment in homeo powerpoint medications presentation measuring fasting plasma glucose concentration is an easier screening procedure for gestational diabetes mellitus than the 1 hour 50 g glucose challenge test. In type 1 diabetes (which used to be called insulin-dependent diabetes or juvenile diabetes) the pancreas can’t make insulin. Physical therapy may also help patients with muscle cramps muscle This programme will be delivered over 6 interactive half day what are the classic symptoms of type 1 diabetes touch walgreens meter glucose one sessions. Hazard ratios were lower, but not significantly so, for fatal or non-fatal coronary heart disease and fatal or non-fatal cardiovascular disease. The type of insulin your doctor recommends will depend on how your body responds to the insulin and how you want to Our version has all the richness you’ll need but about 90 fewer calories than store-bought premium ice cream and a whopping 15 grams less total fat and 10 grams less saturated fat per serving. A trial of nicotinamide in newly diagnosed patients with type 1 (insulin-dependent) diabetes mellitus.
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We were given the 25 test strips In Type 2 diabetes the It is important to notify your pediatrician immediately if your child displays any of the following warning signs and symptoms of diabetes rice krispie treat (christmas variation). We are a full service wellness center serving the community in Oakland and the surrounding Bay Area at our Temescal location on Piedmont Avenue. When lower body mass index and previous cardiovascular diseases were excluded, results of subgroup analyses were similar to the results from complete data. For the eating out scenario, closed loop delivery increased the time plasma glucose levels were in target by a median 28% (2-39%), P=0.01. People with diabetes either do not produce enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes) or both (which occurs with several forms of diabetes). Data on patient education and frequency of blood glucose monitoring were missing, which might have influenced the observed association.Conclusion Among people with type 1 diabetes use of insulin pump therapy is associated with lower cardiovascular mortality than treatment with multiple daily insulin injections.
IntroductionNobody disputes the fact that type 1 diabetes increases the risk of death from cardiovascular diseases. The person with the pump administers doses to cover meals and correct blood glucose concentrations. Combining continuous glucose monitoring with pump therapy can improve the control of glucose,11 but responding to overnight real time data detected by sensor is impractical.
Many pumps these days have a bolus wizard that calculates how much insulin the person needs, taking expected carbohydrate intake, current blood glucose concentrations and previously still active insulin into consideration. The studies mimicked the two common scenarios of “eating in” and “eating out” in preparation for testing as an outpatient. In an initial study we evaluated closed loop delivery after a medium sized evening meal, mimicking an evening at home when closed loop delivery could be conveniently started with the meal. Over half of all Swedish children with type 1 diabetes also use insulin pumps.7 Sceptics argue that subcutaneous infusion of insulin by a pump could increase costs of treatment and cause practical problems for people with diabetes. In a second, more challenging, study mimicking an evening out, the meal was larger, was consumed later, and was accompanied by wine. Because of the scarcity of data, the relative risk for cardiovascular disease of associated with the treatments is unknown.Sweden offers excellent opportunities for studying individuals with type 1 diabetes. Inclusion criteria were adults with type 1 diabetes (World Health Organization criteria or confirmed negative for C peptide), aged 18-65, and using insulin pump therapy for at least three months.
About 95% of all individuals with type 1 diabetes have been entered in the National Diabetes Register, which includes detailed clinical data from each appointment.
Exclusion criteria were awareness of reduced hypoglycaemia and clinically significant nephropathy, neuropathy, or retinopathy. The register can be linked via Sweden’s unique personal identity number to the cause of death, inpatient, socioeconomic, and other population based registers.
Our primary aim was to analyse the effect of insulin pump treatment on cardiovascular mortality.MethodsSwedish National Diabetes RegisterThe Swedish National Diabetes Register was initiated in 1996 as a caregiver tool for local quality assurance and to provide feedback as part of diabetes care. Trained doctors and nurses report annually to the register,12 either online or through clinical record systems; no stringent criteria exist for how often patients visit an outpatient clinic.
Figure 2? shows the flow of participants through the study.Fig 2?Flow of participants through study comparing closed loop delivery of insulin with conventional insulin pump therapy after a medium sized evening meal (eating in scenario), and study comparing closed loop delivery with insulin pump therapy after a large evening meal accompanied by alcohol (eating out scenario)Eating in scenarioOf 32 adults invited to take part in the study, 13 agreed and were randomly assigned to be treated overnight with either closed loop delivery of insulin or conventional insulin pump therapy during two study nights, separated by an interval of one to three weeks.
Information is collected during appointments at hospital outpatient clinics and primary healthcare centres nationwide. Before the first study visit we analysed data from continuous glucose monitoring for up to 120 hours to optimise the delivery of insulin by conventional pump therapy.
Several previous reports have been published concerning trends in risk factor control and risk prediction based on the register,1 13 14 including a more detailed description of the register and the Swedish healthcare system for patients with diabetes.15Patient involvementThere was no patient involvement in this study. On both visits participants ate an identical evening meal, comprising 60 g of carbohydrate, at 1900, accompanied by prandial insulin. The work within the Swedish National Diabetes Register, as this article, is done in a continuous but informal dialogue with people with diabetes.ParticipantsWe included 18?168 people with type 1 diabetes entered in the Swedish National Diabetes Register for whom data were available about the use of insulin pump therapy or multiple daily injections. We calculated the prandial boluses according to the participants’ own insulin to carbohydrate ratio and glucose values from finger stick testing. A total of 2441 people were being treated with insulin pump therapy during the study period from baseline to the final year, and 15?727 were treated with multiple daily injections during the whole study period to final year. During the intervention visit, closed loop insulin delivery was applied from 1900 until 0800 the next day.
Type 1 diabetes was epidemiologically defined as all patients who received insulin treatment only (for diabetes mellitus) and were aged under 30 at onset, almost all of whom had been reported by outpatient clinics from about 90 Swedish hospitals.
During the intervention visit, insulin was delivered by closed loop from 2200 until 1200 the next day.
During the control visit, participants applied their usual insulin pump settings over the same timeframe.Continuous glucose monitoring and insulin deliveryTo measure subcutaneous glucose in the eating in scenario we used the continuous glucose monitoring system FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) with a 10 hour run-in calibration period.


In the eating out scenario we used FreeStyle Navigator with a one hour run-in calibration period. The systems were calibrated using capillary finger stick measurements as per manufacturer’s instructions. Physical activity was graded as low (no activity or less than once a week) or higher (twice or more a week). Smoking was defined as one or more cigarettes a day, one pipe a day, or having quit within the past three months. The Swedish standard for recording blood pressure as used by the Swedish National Diabetes Register is the average (mm Hg) of two supine readings (Korotkoff sounds I-V) with a cuff of appropriate size after at least 5 minutes of rest. The calculations utilised a compartment model of glucose kinetics,20 describing the effect of rapid acting insulin and the carbohydrate content of meals on glucose excursions detected by the sensor. The algorithm was initialised using participant’s weight, total daily insulin dose, and basal insulin requirements. Additionally, the algorithm was provided with glucose levels measured by the sensor during a 30 minute period preceding the start of closed loop delivery, the carbohydrate content of the evening meal, and the prandial insulin bolus. Change in HbA1c during the study period was estimated as the difference between baseline and final measurements, the latter estimated as the value before the year of an event or otherwise the value in 2012.
The algorithm adapted itself to participants by updating two model variables: an endogenous glucose flux correcting for errors in model based predictions, and carbohydrate bioavailability. Hypoglycaemic attacks that required a hospital admission, with ICD-10 codes for hypoglycaemia and coma from the hospital discharge register, were entered during the study period from baseline until 31 December 2012.Follow-up and definition of endpointsAll individuals were monitored from the baseline examination until death or the first incident or until 31 December 2012.
The major primary endpoints were fatal or non-fatal coronary heart disease, fatal or non-fatal cardiovascular disease, fatal cardiovascular disease, and total mortality.
In the eating in scenario we collected samples between 1830 and 0800 and in the eating out scenario between 1930 and 1200. Stroke was defined as fatal or non-fatal cerebral infarction, intracerebral haemorrhage, or unspecified stroke (ICD-10 codes I61, I63, I64).
These data were not used to alter insulin infusion rates during the visits for closed loop delivery or control. Cardiovascular disease was defined as the composite of coronary heart disease or stroke, whichever came first. A secondary endpoint was mortality from non-cardiovascular disease.A history of heart failure was defined as ICD-10 code I50, and atrial fibrillation before the study start was defined as ICD-10 code I48.
We calculated that 12 participants would provide 80% power at the 5% level of significance to detect this difference between conventional and closed loop insulin delivery systems.Randomisation and maskingFor each study we placed a computer generated allocation sequence with permuted block four randomisation in sealed envelopes. We used crude Kaplan-Meier curves for all outcomes to compare the two groups with log rank test and for observed hypoglycaemic episodes during study follow-up.We estimated a propensity score for treatment with pump with logistic regression as the conditional probability of being treated with pump given the baseline characteristics,20 21 including the covariates age, sex, duration of diabetes, history of cardiovascular disease, heart failure, atrial fibrillation, baseline HbA1c, systolic and diastolic blood pressure, BMI, total and high density lipoprotein cholesterol, triglycerides, cumulative microalbuminuria, creatinine, renal insufficiency, smoking, physical activity, antihypertensive drugs, lipid lowering drugs and aspirin, educational levels, yearly income, marital status and baseline years. We calculated P values for differences between the two treatment groups after adjustment with the propensity score, including all 36 variables, estimated by generalized linear models (link id for continuous data and link logit for dichotomous data). For safety reasons, during the eating out scenario investigators had access to plasma glucose levels.
During both studies, participants did not have access to data on plasma or sensor glucose levels.Statistical analysisSenior investigators and study statisticians agreed on the analysis plan in advance. Standardised differences between the two groups were sufficiently low and clearly below 10% for all covariates. We estimated glycaemic variability by mean amplitude of glycaemic excursions22 and standard deviation of glucose concentration. The distribution of the propensity score among the fifths (see appendix table A) shows a satisfactory overlap between the two treatment groups, as well as a sufficient number of outcomes by each fifth of the score. The mean percentage of missing data among all 36 variables was 5%—the highest proportions were for physical activity (32%), total cholesterol (25%), high density lipoprotein cholesterol (22%), triglycerides (21%), creatinine (11%), microalbuminuria (10%), and BMI (9%).Table 1 ?Baseline data for 18 168 individuals with type 1 diabetes followed for seven years until 2012 according to insulin treatment by insulin pump therapy or multiple daily injections (MDIs).
There were 1423 cases of fatal or non-fatal cardiovascular disease during the study period. Figure 3? shows the profiles of plasma glucose and plasma insulin concentrations and insulin infusion. Non-significantly lower hazard ratios were found for fatal or non-fatal cardiovascular disease. Insulin infusion was more variable during closed loop delivery, but the average insulin infusion rate and plasma insulin concentrations were similar during closed loop delivery and control visits (fig 3).Fig 3?Profiles (medians and interquartile ranges) of plasma glucose and insulin concentrations and insulin infusion in eating in scenario (12 participants). Hazard ratios associated with insulin pump treatment were given different prevalences of this confounder between two groups. The hazard ratios for the other endpoints were not significant.Another subgroup analysis of the 10?282 patients with complete data for all variables in table 1 also showed similar results to the results for all patients (tables C and D in appendix). Differences between the pump therapy and injection groups for all variables after adjustment with a propensity score were not significant—standardised differences were sufficient and clearly below 10%.
As for the eating in scenario, the average overnight infusion of insulin and plasma insulin concentration during closed loop delivery and pump therapy were comparable. The profiles for glucose and insulin levels showed lower variability of plasma glucose during closed loop delivery from 0200 onwards (fig 4?).Fig 4?Profiles (medians and interquartile ranges) of plasma glucose and insulin concentrations and insulin infusion in the eating out scenario (12 participants). The number of patients admitted to hospital for hypoglycaemic incidents during the study period was 148 in those treated with pump therapy and 967 in those treated with injections, and the number of hypoglycaemic incidents was 206 and 1366, respectively (table F in appendix).Fig 2?Kaplan-Meier survival curves for first incident hypoglycaemic events in patients with type 1 diabetes during seven years of follow-up. Three were attributable to the preceding prandial insulin dose and could not be prevented despite suspended insulin delivery immediately after the start of closed loop. Three episodes were treated with 15-36 g of oral carbohydrates in drink (Lucozade; GlaxoSmithKline, Brentford, UK) and the fourth lasted 30 minutes with spontaneous recovery. Among 2441 of those treated with insulin pump therapy and 15?727 treated with multiple daily injections, insulin pump treatment was associated with a reduction of 45% for fatal coronary heart disease, 42% for fatal cardiovascular disease, and 27% for all cause mortality. The episode was not associated with symptoms but was treated with 30 g of oral carbohydrates in drink. The remaining four events were not associated with symptoms; all but one event occurred after 0100 and were not treated.
The Diabetes Control and Complication Trial has shown that good glycaemic control for six years with follow-up for 11 years can significantly decrease the risk of any cardiovascular disease event by 42% and the risk of non-fatal myocardial infarction, stroke, or death from cardiovascular disease by 57%.2 At the group level, it is clear that sensor-augmented pump therapy provides better metabolic control than multiple daily injections in adults with type 1 diabetes. A study in the United States and Canada randomised 329 adults with type 1 diabetes to insulin with sensor-augmented pump therapy or multiple daily injections.
After one year, HbA1c had been reduced by 1.0% from baseline among those who had been randomised to sensor-augmented pump therapy. Closed loop delivery significantly reduced the variability in plasma glucose levels and reduced time when the levels were above target (table 5?). Each individual with type 1 diabetes who was entered as being treated with insulin pump therapy or multiple daily injections was reported to the Swedish National Diabetes Register by local units.


Closed loop delivery consistently outperformed conventional insulin pump therapy at both high and low glucose values (fig 5?).Fig 5?Distribution of plasma glucose values during closed loop insulin delivery and conventional insulin pump therapy (continuous subcutaneous insulin infusion) combining data collected from midnight until end of the eating in scenario and the eating out scenario. Nobody was excluded from the study during follow-up, and we have valid information for almost every Swede who has been diagnosed with type 1 diabetes,12 as well as information regarding the occurrence of cardiovascular disease and death outcomes using established national registers.17 18 The propensity score allowed for balancing 36 covariates between the insulin pump and multiple daily injection groups, including strong cardiovascular risk factors and important social data—there were only non-significant differences and small standardised differences for all covariates. Percentages represent total time plasma glucose level was below, at, and above target from midnight until end of closed loop deliveryTable 5 ?Comparisons between closed loop delivery of insulin and conventional insulin pump therapy based on plasma glucose concentrations after pooling results for two meal scenarios: eating in and eating out.
The stratification into fifths of the score for adjustment at the Cox regressions permitted use of all available patients in the study. The analysis of a somewhat smaller sample with complete data and no imputation confirmed our results, which indicated that missing data were random.We observed clinical practice in Sweden at the time of the study.
The average dose of insulin delivered during closed loop and conventional pump therapy was comparable, illustrating the key role of glucose responsive insulin delivery to achieve target glucose levels.
There were no strict guidelines for switching from multiple daily injections to insulin pump therapy. The large evening meal and alcohol intake provided a greater challenge to closed loop delivery than did a medium sized evening meal, reflected by a slightly reduced but still superior performance over insulin pump therapy.Strengths and limitations of the studyAn important feature of our closed loop algorithm is avoidance of hypoglycaemia, which if replicated in the home setting would revolutionise patient safety. Among possible reasons for a physician to recommend that an individual with type 1 diabetes switch treatment are unsatisfactory glycaemic control with high HbA1c, large variations in blood glucose concentrations, or the need to improve quality of life by administering insulin more flexibly. The algorithm suspends insulin delivery when the sensor detects a low or rapid fall in glucose levels and does so without increased risk of hyperglycaemia.24 Initiation of the algorithm is straightforward, requiring users to input their weight, total daily insulin dose, and basal infusion rates. The system updates advice on insulin dose using a robust, computationally efficient approach suitable for use with insulin pumps and hand held devices to facilitate practical use.
Obviously we need more data before we can state without reasonable doubt that pump use results in a lower risk of coronary heart disease or cardiovascular disease.Limitations of the studyOne limitation of the study was that we had no information on duration of insulin pump treatment before study baseline, although our aim was to analyse outcomes from baseline during a long term follow-up period.
It can discriminate between slowly or rapidly absorbed meals, thus coping with considerable variability in gut absorption. If the mechanism for the preventive effect of insulin pump treatment on cardiovascular mortality is through a reduced frequency of lethal arrhythmia, we would expect adjustment for the duration of insulin pump treatment to have little or no effect on our hazard ratios. Similarly, variability in insulin absorption is assessed through model based analysis of insulin delivery and the effects on sensor glucose levels.
If instead the mechanism is through events with an induction latency time of a year or more, such as plaque formation, adjustment for duration of insulin pump treatment would give even stronger associations than we found. These adaptive capabilities set our algorithm apart from most existing non-adaptive approaches.25 26 27Additional strengths of our study are that we used the closed loop system in circumstances near to those in real life, without artificially improving performance.
We adjusted the hazard ratio between insulin pump treatment and cardiovascular mortality for baseline values of HbA1c.
Firstly, we used a commercially available continuous glucose monitor calibrated according to manufacturer’s instructions. As some patients had used insulin pumps for some time at baseline, this means that the adjustment might eliminate some of the effect. Secondly, only one sensor was inserted and it was not recalibrated in the event of suboptimal accuracy. That is, if this source of error did not exist, we would have estimated the protective effect of insulin pump treatment on cardiovascular mortality to be larger than we now found.
We did not adjust for HbA1c after baseline as that would be adjusting for a possible mediating factor. Our studies assessed closed loop delivery of insulin in preparation for home testing, when recalibration of a sensor is impractical (particularly overnight), and multiple sensors, although improving accuracy, are inconvenient and likely to affect users’ satisfaction.Limitations are that participants were compliant and predominantly of white ethnicity, hence applicability to less compliant people and those with poor glycaemic control is unknown.
Separate analyses of updated mean HbA1c during the study, or the change between baseline and final HbA1c, however, showed no significant differences between the treatment groups.Mediating factors, to one extent or another, for the effect of insulin pump treatment on cardiovascular mortality might be increased frequency of glucose monitoring, as well as more appropriate actions at various blood glucose concentrations. Also, we did not adjust for multiple statistical comparisons in secondary outcomes; hence these should be considered hypothesis generating rather than conclusive. Changing from multiple daily injections to insulin pump treatment is accompanied by education about insulin pump treatment, which could be useful in reducing the number of episodes of hypoglycaemia and hyperglycaemia. Another limitation is that the research nurse manually entered sensor glucose values into the algorithm and manually adjusted the insulin pump. Moreover, having a pump with the opportunities it offers to fine tune the administration of insulin might itself be an instructive factor. Presumably the lack of automation did not to affect the performance of the closed loop system but will need to be dealt with before proceeding to home testing.
Thus, some of the effect of pump therapy on risk of cardiovascular disease could have been achieved by intensified training of the individual about the disease44 to improve blood glucose monitoring and achieve a better balance between insulin administration, food intake, and physical activity.ConclusionsThis nationwide observational study of individuals with type 1 diabetes shows that treatment with an insulin pump was associated with a considerable reduction in risk of fatal coronary heart disease, fatal cardiovascular disease, and all cause mortality.
This may be attributed to differences in protocol as we opted to omit breakfast and its meal related bolus to mimic sleeping until lunchtime (not uncommon in young adults). The Swedish Society of Diabetology and the Swedish Diabetes Association, a patient advocacy group, support the Swedish National Diabetes Register.
Another difference was that in our study alcohol was consumed within two hours of the evening meal compared with three hours later in the other study.
The results and views expressed in the study represent those of the authors and not necessarily those of the Swedish Medical Products Agency, at which one of the authors (BZ) is employed. BE, AR, KE-O, A-MS, BZ, TA, ML-O, and JJ contributed to the discussion and reviewed and edited the article. As continuous glucose monitors and control algorithms are perfected, devices miniaturised, and performance limiting aspects identified, it is anticipated that early closed loop approaches such as overnight closed loop delivery will be followed by more advanced solutions for control of glucose during both the day and at night. Closed loop systems may serve as a bridge until type 1 diabetes is cured by, for example, stem cell therapy or islet transplantation.In conclusion, closed loop delivery of insulin can significantly improve the control of glucose levels overnight and reduce the risk of nocturnal hypoglycaemia in adults with type 1 diabetes.
The Swedish National Diabetes Register is funded by the Swedish Association of Local Authorities and Regions.
JH, KK, JMA, and DE provided patient care, collected the clinical and laboratory data, and contributed to biochemical analysis. MEW, DX, MN, RH, KK, and CK carried out or supported the data analysis, including the statistical analyses.
RH, KK, MLE, SAA, SRH, HRM, DBD, and MEW contributed to the interpretation of the results and the writing and critical review of the report. Smiths Medical supplied the study pumps and Abbott Diabetes Care supplied the Freestyle Navigator devices and sensors for the eating in scenario.



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