***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE Insulin pump therapy ( continuous subcutaneous insulin infusion [ CSII ] ) and multiple daily injections ( MDIs ) with insulin glargine as basal insulin and mealtime insulin lispro have not been prospect ively compared in people naïve to either regimen in a multicenter study . We aim ed to help close that deficiency . RESEARCH DESIGN AND METHODS People with type 1 diabetes on NPH-based insulin therapy  were r and omized to CSII or glargine-based MDI ( both otherwise using lispro ) and followed for 24 weeks in an equivalence design . Fifty people were correctly r and omized , and 43 completed the study .  RESULTS Total insulin requirement ( mean ± SD ) at end point was 36.2 ± 11.5 units/day on CSII and 42.6 ± 15.5 units/day on MDI . Mean A1C fell similarly in the two groups ( CSII −0.7 ± 0.7 % ; MDI −0.6 ± 0.8 % ) with a baseline-adjusted difference of −0.1 % ( 95 % CI −0.5 to 0.3 ) . Similarly , fasting blood glucose and other prepr and ial , postpr and ial , and nighttime self-monitored plasma glucose levels did not differ between the regimens , nor did measures of plasma glucose variability . On CSII , 1,152 hypoglycemia events were recorded by 23 of 28 participants ( 82 % ) and 1,022 in the MDI group by 27 of 29 patients ( 93 % ) ( all hypoglycemia differences were nonsignificant ) . Treatment satisfaction score increased more with CSII ; however , the change in score was similar for the groups . Costs were ∼3.9 times higher for CSII . CONCLUSIONS In unselected people with type 1 diabetes naïve to CSII or insulin glargine , glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy OBJECTIVE Multiple daily injection ( MDI ) therapy of bolus insulin aspart and basal insulin glargine was compared with continuous subcutaneous insulin infusion ( CSII ) with aspart in type 1 diabetic patients previously treated with CSII . RESEARCH DESIGN AND METHODS One hundred patients were enrolled in a r and omized , multicenter , open-label , crossover study . After a 1-week run-in period with aspart by CSII , 50 subjects were r and omly assigned to MDI therapy ( aspart immediately before each meal and glargine at bedtime ) and 50 subjects continued CSII . After 5 weeks of the first treatment , subjects crossed over to the alternate treatment for 5 weeks . During the last week of each treatment period , subjects wore a  continuous glucose monitoring system  for 48 - 72 h. RESULTS Mean serum fructosamine levels were significantly lower after CSII therapy than after MDI therapy ( 343 + /- 47 vs. 355 + /- 50 micromol/l , respectively ; P = 0.0001 ) . Continuous glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and 40 % lower for CSII than MDI as measured by area under the curve ( AUC ) glucose > /=80 mg/dl ( 1,270 + /- 742 vs. 1,664 + /- 1,039 mg . h . dl(-1 ) ; P < 0.001 ) and AUC glucose > /=140 mg/dl ( 464 + /- 452 vs. 777 + /- 746 mg . h . dl(-1 ) , CSII vs. MDI , respectively ; P < 0.001 ) . Similar percentages of subjects reported hypoglycemic episodes ( CSII : 92 % , MDI : 94 % ) and nocturnal ( 12:00 a.m. to 8:00 a.m. ) hypoglycemic episodes ( CSII : 73 % , MDI : 72 % ) . Major hypoglycemia was infrequent ( CSII : two episodes , MDI : five episodes ) . CONCLUSIONS In a trial of short duration , CSII therapy with insulin aspart result ed in lower glycemic exposure without increased risk of hypoglycemia , as compared with MDI with insulin aspart and glargine OBJECTIVE Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control . METHODS An open , parallel , r and omized controlled prospect i ve comparative study lasting 14 months was completed by 38 type 1 children with diabetes ( age 4 - 16 yr ) following a 3.5-months run-in phase . St and ardized quality -of-life Pediatric Quality of life Inventory ( PedsQL ) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters . Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality . RESULTS Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment . Treatment group comparisons did not show significant improvement . Pump treatment result ed in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22 % after run in . CONCLUSIONS Within-patient comparison suggests that metabolic control , frequency of severe hypoglycaemia ( a threefold decrease ) , quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections AIMS The goal of the study was to determine whether continuous subcutaneous insulin infusion ( CSII ) differs from a multiple daily injection ( MDI ) regimen based on neutral protamine hagedorn ( NPH ) as basal insulin with respect to glycaemic control and quality of life in people with Type 1 diabetes . METHODS The 5-Nations trial was a r and omized , controlled , crossover trial conducted in 11 European centres . Two hundred and seventy-two patients were treated with CSII or MDI during a 2-month run-in period followed by a 6-month treatment period , respectively . The quality of glycaemic control was assessed by HbA(1c ) , blood glucose values , and the frequency of hypoglycaemic events . For the evaluation of the quality of life , three different self-report question naires have been assessed . RESULTS CSII treatment result ed in lower HbA(1c ) ( 7.45 vs. 7.67 % , P < 0.001 ) , mean blood glucose level ( 8.6 vs. 9.4 mmol/l , P < 0.001 ) and less fluctuation in blood glucose levels than MDI ( + /- 3.9 vs. + /- 4.3 mmol/l , P < 0.001 ) . There was a marked reduction in the frequency of hypoglycaemic events using CSII compared with MDI , with an incidence ratio of 1.12 [ 95 % confidence interval ( CI ) : 1.08 - 1.17 ] and 2.61 ( 95 % CI : 1.59 - 4.29 ) for mild and severe hypoglycaemia , respectively . The overall score of the diabetes quality of life question naire was higher for CSII ( P < 0.001 ) , and an improvement in pump users ' perception of mental health was detected when using the SF-12 question naire ( P < 0.05 ) . CONCLUSION CSII usage offers significant benefits over NPH-based MDI for individuals with Type 1 diabetes , with improvement in all significant metabolic parameters as well as in patients ' quality of life . Additional studies are needed to compare CSII with glargine- and detemir-based MDI No long-term data are available on the efficacy of glargine insulin in comparison with continuous sc insulin infusion ( CSII ) in children and adolescents affected by Type 1 diabetes ( T1D ) . Our aim was to compare the 2-yr efficacy of the 2 insulin approaches , in order to know how to best supply basal insulin in these patients . Thirty-six 9 to 18-yr-old consecutive children with at least 3 yr previous T1D diagnosis were enrolled . As part of routine clinical care , the patients consecutively changed their previous insulin scheme ( isophane insulin at bedtime and human regular insulin at meals ) and were r and omly selected in order to receive either multiple daily injections ( MDI ) treatment with once-daily glargine and human regular insulin at meals , or CSII with aspart or lispro insulin . Both groups showed a significant decrease in glycosylated hemoglobin ( HbA1c ) values during the 1st year of therapy , though only in the CSII treated children was the decrease also observed during the 2nd year . The overall insulin requirement significantly decreased only in the CSII group and exclusively during the 1st year , while no significant differences were observed concerning body mass index SD score , severe hypoglycémic episodes and basal insulin supplementation . The work illustrates the first long-term study comparing the efficacy of CSII to MDI using glargine as basal insulin in children . Only with CSII were better HbA1c values obtained for prolonged periods of time , so that CSII might be considered the gold st and ard of intensive insulin therapy also for long-term follow-ups OBJECTIVE To assess the impact of continuous glucose monitoring on hypoglycemia in people with type 1 diabetes . RESEARCH DESIGN AND METHODS In this r and omized , controlled , multicenter study , 120 children and adults on intensive therapy for type 1 diabetes and a screening level of glycated hemoglobin A1c ( HbA1c ) < 7.5 % were r and omly assigned to a control group performing conventional home monitoring with a blood glucose meter and wearing a masked continuous glucose monitor every second week for five days or to a group with real-time continuous glucose monitoring . The primary outcome was the time spent in hypoglycemia ( interstitial glucose concentration < 63 mg/dL ) over a period of 26 weeks . Analysis was by intention to treat for all r and omized patients . RESULTS The time per day spent in hypoglycemia was significantly shorter in the continuous monitoring group than in the control group ( mean ± SD 0.48 ± 0.57 and 0.97 ± 1.55 h/day , respectively ; ratio of means 0.49 ; 95 % CI 0.26–0.76 ; P = 0.03 ) . HbA1c at 26 weeks was lower in the continuous monitoring group than in the control group ( difference −0.27 % ; 95 % CI −0.47 to −0.07 ; P = 0.008 ) . Time spent in 70 to 180 mg/dL normoglycemia was significantly longer in the continuous glucose monitoring group compared with the control group ( mean hours per day , 17.6 vs. 16.0 , P = 0.009 ) . CONCLUSIONS Continuous glucose monitoring was associated with reduced time spent in hypoglycemia and a concomitant decrease in HbA1c in children and adults with type 1 diabetes Aims /hypothesisThe value of managing children with type 1 diabetes using a combination of insulin pump and continuous glucose monitoring starting from diagnosis for improving subsequent glycaemic control and preserving residual beta cell function was determined . Methods A total of 160 children ( aged 1–16 years , mean ± SD : 8.7 ± 4.4 years ; 47.5 % girls ) were r and omised to receive insulin pump treatment with continuous glucose monitoring or conventional self-monitoring blood glucose measurements . The primary outcome was the level of HbA1c after 12 months . Other analyses included fasting C-peptide , glycaemic variability , sensor usage , adverse events , children ’s health-related quality of life and parent ’s wellbeing . Results HbA1c was not significantly different between the two groups , but patients with regular sensor use had lower values ( mean 7.1 % , 95 % CI 6.8–7.4 % ) compared with the combined group with no or low sensor usage ( mean 7.6 % , 95 % CI 7.3–7.9 % ; p = 0.032 ) . At 12 months , glycaemic variability was lower in the sensor group ( mean amplitude of glycaemic excursions 80.2 ± 26.2 vs 92.0 ± 33.7 ; p = 0.037 ) . Higher C-peptide concentrations were seen in sensor-treated 12- to 16-year-old patients ( 0.25 ± 0.12 nmol/l ) compared with those treated with insulin pump alone ( 0.19 ± 0.07 nmol/l ; p = 0.033 ) . Severe hypoglycaemia was reported only in the group without sensors ( four episodes ) . Conclusion /interpretationSensor-augmented pump therapy starting from the diagnosis of type 1 diabetes can be associated with less decline in fasting C-peptide particularly in older children , although regular sensor use is a prerequisite for improved glycaemic control . Trial registration IS RCT N.org IS RCT N05450731 Funding Medtronic International Trading Sàrl , Tolochenaz 
    Output:
    
SUMMARY The AHRQ systematic review of r and omized clinical trials reveals that both insulin delivery modalities ( CSII and MDI ) demonstrate similar effectiveness on glycemic control and severe hypoglycemia in children and adolescents with T1DM and in adults with T2DM .
In children and adults with T1DM , the use of CSII was associated with improved quality of life compared with MDI , with low strength of evidence , while there was insufficient strength of evidence to make conclusions regarding the quality of life for adults with T2DM .
The study investigators suggest that the modality to deliver intensive insulin therapy can be individualized to patient preference in order to maximize quality of life .
On all measured outcomes , there was insufficient or low strength of evidence regarding pregnant women with pre-existing diabetes .
The systematic review demonstrates that rt-CGM is associated with greater lowering of A1c compared with SMBG ( high strength of evidence ) without affecting the risk of severe hypoglycemia ( low strength of evidence ) or quality of life ( low strength of evidence ) in nonpregnant individuals with T1DM , particularly when compliance with device use is high .
Additional findings suggest that the use of sensor-augmented insulin pumps ( rt-CGM + CSII ) is superior to the use of MDI/SMBG use in lowering A1c in nonpregnant individuals with T1DM ( moderate strength of evidence ) .