Ongoing managementphysician. The study found no difference between the groups in terms of HbA 1c levels(8.6 ± 1.7% versus 8.6 ± 1.2%, p = 0.89), occurrence of mild to moderate hypoglycaemic events(2.9 times/day versus 3.0 times/day, p = 0.91) or patient satisfaction.Cost analysis was performed on the use of modem-transmitted blood glucose information. Thecost estimates included patients’/families’ out of pocket expenses and time as well as healthservice costs and the cost of the new technology. The intervention group incurred fewer expensesand less lost productivity (parental time off work) than the control group (p < 0.001). Since therewere no reported differences in adverse outcomes, the lower cost of the intervention group madeit a viable alternative at almost half the cost ($163 versus $305). However, sensitivity analysis onthe resources that are most difficult to value (lost time/productivity, costs of new technology) wasnot performed. Also, the relatively high reported fee for a clinic visit ($246, range $235–310)accounted for most of the cost of the standard care group. The cost of specialist clinic visits forpatients of all ages was reported in a survey of UK providers to be £67 at 1997 prices, 373 which isa much lower cost and so the relative cost effectiveness would not be the same in the UK.Plastic insulin dose guide compared with paper algorithmAn RCT compared a plastic insulin dose guide with a paper algorithm as a guide for patientadjustedinsulin dose in 40 children with type 1 <strong>diabetes</strong>. The study found no significantdifference in HbA 1c levels. However, mean blood glucose levels decreased with the dose guidecompared with the algorithm (9.2 ± 1.2 mmol/l versus 11.8 ± 1.6 mmol/l), whereas patientacceptance increased with the dose guide (5.0 versus 3.4 Likert 0–5 scale), and the timeneeded to teach the patient to use the guide increased (from 18 to 43 minutes). 374 [evidencelevel Ib]Alternative body sites for blood glucose monitoringSeven observational studies examined the impact of blood glucose monitoring at alternativesites. None of the studies looked specifically at children or young people, and none of thestudies investigated long-term outcomes related to complications or glycaemic control. Sevenstudies compared blood glucose measurements from the traditional site (the finger) to those froman alternative site (for example, the arm). Six studies found strong correlations between forearmblood glucose monitoring and finger blood glucose monitoring. 375–380 [evidence level IIa] Onestudy found changes in blood glucose after a meal may be identified at finger sites beforedetection at forearm or thigh sites. 381 [evidence level IIa] Two studies looked at patientacceptability of alternative sites for blood glucose monitoring. One study found that 76% ofpatients preferred a monitor that could be used for sites other than the finger (n = 121 patientswith type 1 or type 2 <strong>diabetes</strong>). 382 [evidence level IIa] The second study reported that 97% ofpatients found arm blood glucose testing less painful than finger testing (n = 378 patients withtype 1 or type 2 <strong>diabetes</strong>). 378 [evidence level IIa]Continuous glucose monitoring systemsSelf-monitoring of blood glucose provides a snapshot of glucose levels during the day, butmarked glycaemic excursions can be missed in periods when no glucose level is taken.Continuous glucose monitoring systems (CGMSs) measure interstitial fluid glucose and provideinformation about continuous glucose fluctuations that is not captured by intermittent bloodglucose testing. 383 [evidence level IV]CGMSs require calibration with finger-stick tests and supplement, but do not replace,conventional blood glucose testing. 383 [evidence level IV] CGMS measurements correspond toblood glucose values taken approximately 13–18 minutes earlier and may differ from bloodglucose monitor readings. 383 [evidence level IV] We identified two groups of CGMSs: invasivedesigns and non-invasive designs.Invasive continuous glucose monitoring systemsInvasive continuous glucose monitoring systems can be used for up to 72 hours. 384 [evidencelevel IV]We found two RCTs evaluating the invasive CGMS MiniMed®. In one RCT (n = 11 children andyoung people), the intervention group used the invasive CGMS for 18 days out of a 30-day period75
<strong>Type</strong> 1 <strong>diabetes</strong>as well as performing at least four blood glucose tests/day. The intervention group was comparedwith a control group that performed at least four blood glucose tests/day. For both groups, glucosemonitoring results were reported to a member of the <strong>diabetes</strong> clinic staff, and insulin doseadjustments were made over the telephone. More asymptomatic biochemical hypoglycaemicevents were identified in the intervention group (12.8 ± 1.6 versus 6.7 ± 1.1), and these resultedin more changes of insulin dose (11.5 ± 1.5 versus 5.2 ± 0.9). There was no significant differencebetween HbA 1c levels in the two groups after 3 months. The groups showed no significantdifference in fear of hypoglycaemia, or DCCT quality of life. 385 [evidence level Ib] The second RCTinvestigated the use of a CGMS for 3 days every 2 weeks, creating a profile that was used to adjustinsulin therapy at follow-up visits every 6 weeks, compared with patients who used a CGMS for3 days every 2 weeks without making the results available to patients or <strong>diabetes</strong> team with insulintherapy adjustments being made solely on the basis of 7-point blood glucose profiles recorded bythe patients (n = 27, age range 7–19 years). The study found that HbA 1c levels were reduced whenthere was access to the results of the CGMS compared with when there was no access (7.31%versus 7.65%, p = 0.011). 386 [evidence level Ib]We also found 24 studies that evaluated the use of invasive CGMSs compared with bloodglucose monitoring. 387–410 [evidence level IIb] Of these, 18 investigated the same invasive CGMSas the above RCTs, and five investigated other invasive CGMSs. Ten studies showed strongcorrelations between glucose levels measured by invasive CGMSs and conventional bloodglucose monitoring. 387–389,393,396,399,403,404,407,410 [evidence level IIa] Invasive CGMSs detected moreasymptomatic biochemical hypoglycaemia. 392,393,406,408 [evidence level IIa] Short-term use ofinvasive CGMSs combined with information advising patients when and how to change insulinregimen and/or dose was found to reduce HbA 1c compared with baseline in one study inchildren and two studies in adults (child study: reduction at 3 months 0.40 ± 0.94%, reductionat 6 months 0.43 ± 0.87%; 408 first adult study: 8.5 ± 0.9% versus 10.3 ± 0.6%, p < 0.01, n = 10adults; 397 second adult study: 8.5 ± 0.9% versus 10.3 ± 0.6%, p < 0.01, n = 10 adults). 397 [evidencelevel IIa] However, a further study found no change in HbA 1c levels. 393 [evidence level IIa] Fourstudies that evaluated pain and irritation with invasive CGMSs reported that the devices weretolerated with only occasional adverse events. 388,400,403,405 [evidence level IIa] One study reportedstrong reaction to adhesive (2/66 children). 409 [evidence level IIa]Non-invasive blood glucose monitoringSeveral systems for measuring glucose non-invasively through the skin are currently beinginvestigated. These include electrochemical enzyme sensors, transcutaneous near-infraredspectroscopy, 411,412 optical glucose sensors, and infrared spectroscopy. 413Electrochemical enzyme sensors have shown strong correlations between glucose measuredcontinuously and that measured conventionally. However, the device was reported to beuncomfortable, causing redness, itching and tingling. 414–416 [evidence level IIa]One RCT investigated the use of electrochemical enzyme sensors in children and young peoplewith type 1 <strong>diabetes</strong> (n = 40). The study found a reduction in HbA 1c (8.4% versus 9.0%, no SDgiven, p < 0.05), an increase in the frequency of detection of hypoglycaemia (bloodglucose ≤ 70 mg/dl, no values given, p < 0.0003), There was no change in fear of hypoglycaemia(59 ± 14.3 versus 56.4 ± 9.6) or quality of life (81.3 ± 11.7 versus 79.8 ± 15.5). 417 [evidence levelIb] A pilot study conducted as part of this RCT evaluated the cost effectiveness and cost/QALYof standard care versus standard care plus the electrochemical enzyme sensor. The studyreported resource use and costs in the USA and used a simulation model to predict futurelifetime costs and outcomes of children in both groups. Cost effectiveness ratios were reportedas costs/life year and costs/QALY but without description of how the QALY weights werederived. 418 The cost of standard care was $6252/year and the cost of enhanced care with theelectrochemical enzyme sensor was $9127 for the first year and $9017/year thereafter. Thesimulation model showed that enhanced care yielded an additional 0.66 QALYs and thecost/additional QALY was $61,326 (approximately £33,000/QALY). These preliminary results,which were not based on long-term follow up, suggested that enhanced care with theelectrochemical enzyme sensor was an effective but expensive option for monitoring glucose. 41876
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Type 1 diabetes: diagnosisand manag
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ContentsGuideline Development Group
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Guideline DevelopmentGroup membersh
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Guideline Development Group members
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Glossary of termsBiasBlinding or ma
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Glossary of termsCross-sectional st
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Glossary of termsPowerProspective s
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Glossary of termsSystematic reviewV
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Type 1 diabetesA separate guideline
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Type 1 diabetesTable 1.1 Levels of
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Type 1 diabetesTable 1.3Outcome cat
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Type 1 diabetesAt the time of diagn
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Type 1 diabetesChildren and young p
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Type 1 diabetesChildren and young p
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Type 1 diabetes• As symptoms impr
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Type 1 diabetes6.2 Anxiety and depr
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Type 1 diabetes2.2 Future research
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3. Diagnosis and initialmanagement3
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Type 1 diabetesRESEARCH RECOMMENDAT
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Type 1 diabetesYoung people with ty
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Type 1 diabetesRecommendation Crite
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Appendix AType 1 diabetes in childr
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Appendix ASometimes, it’s possibl
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Appendix AChildren’s diabetes car
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Appendix AIf a child or young perso
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Appendix Aperson who has multiple d
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Appendix A• Providing they are aw
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Appendix Aespecially linked to chil
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Appendix AFor further information a
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Appendix BClinical evidence forest
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Appendix BFigure B.3 HbA 1c - studi
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Appendix BFigure B.5 Hypoglycaemic
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Appendix BFigure B.7 Patient prefer
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Appendix CYoung people’s consulta
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Appendix DManagement of diabetic ke
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Appendix DA. General:Always accept
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Appendix D• staffing levels on th
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Appendix D• If needed, a solution
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Appendix DAPPENDIX 1Glasgow Coma Sc
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References1. Smith AHK. The Nationa
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References59. Satman I, Dinccag N,
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References2003 [unpublished].121. N
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Referencesinsulin lispro in continu
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Referencesin diabetic patients. Ann
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References301. Kilpatrick ES. Probl
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References367. Marrero DG, Kronz KK
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References428. Donaghue KC, Pena MM
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References496. Edge JA, Ford-Adams
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References1995;38:607-11.562. Morte
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References627. Harrison-Woolrych M,
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Indexacademic achievement 114acarbo
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Indexdiagnosis 22-4, 134-5algorithm
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Indexrecommendations 13, 88immunoth
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Indexneonates (newborn babies) 6, 1
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Indexsuicide 111sulphonylureas 64-5