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114 Pract Diab Int April 2008 Vol. 25 No. 3 Copyright © 2008 John Wiley & Sons

IntroductionThe availability of insulin pumptherapy and continuous glucosemonitoring systems is still patchyacross the UK. The aim of this article is to describe some of thepractical steps involved in establish-ing new technologies within dia-betes care as part of a secondarycare diabetes service.

BackgroundIn patients with type 1 diabetes, theDiabetes Control and ComplicationsTrial (DCCT) convincingly demon-strated the benefits of tight gly-caemic control in reducing the risksof developing microvascular compli-cations in both the short and longerterms.1 Within the DCCT thereappeared to be additional benefitsfor patients using continuous sub-cutaneous insulin infusions (CSIIinsulin pump therapy) in terms oflower achieved HbA1c levels com-pared to those using multiple dailyinjections (MDIs) of insulin.2 As aconsequence, we decided in the late1990s to explore the possibility ofincorporating insulin pump therapyas an option for type 1 patientsattending a UK district general hos-pital diabetes specialist clinic. Thefirst patient in Bournemouth to useCSII started in 1998. Subsequently,meta-analyses3,4 have supported ourclinical experience that insulinpump therapy should be availablefor type 1 patients because of

demonstrable benefits, includingthe following.• Improved glycaemic control.Meta-analyses suggest reductions inachieved HbA1c levels of around0.5–0.9% compared to MDI therapy,which is in keeping with our ownexperience (see below). This is alsosupported by clinical experienceelsewhere in the UK and Europe.5–8

• Fewer glycaemic excursions aboveand below target levels compared totraditional injection therapy. Suchglycaemic excursions are especiallyfrustrating for individuals living on aday-to-day basis with type 1 diabetes.If asked, patients frequently describe

symptoms of malaise and lethargy as blood glucose levels rise into the early to mid teens. Although not proven in laboratory studies,patients also invariably report hypo-glycaemic symptoms as blood glu-cose levels fall towards the hypogly-caemic thresholds.• Reduction in the risk of severehypoglycaemic episodes, particu-larly at night. Despite advances ineducation and the technology asso-ciated with modern diabetes care,fear of hypoglycaemia still remains amajor concern for patients, some ofwhom eschew achieving optimalcontrol as a consequence.

Continuous subcutaneous insulin infusion(CSII insulin pump therapy) for type 1diabetes: a Bournemouth perspective D Kerr*, H Nicholls, J James

ABSTRACTThe first patient in Bournemouth to use insulin pump therapy started in 1998.Subsequently, meta-analyses have supported our clinical experience that, for carefullyselected individuals with type 1 diabetes, insulin pump therapy is associated with:reductions in HbA1c of 0.5–0.9% compared to multiple injection therapy; fewer glycaemicexcursions above and below target levels compared to traditional injection therapy withpatients reporting marked improvements in well-being; reduction in the risk of severehypoglycaemic episodes, particularly at night; and improved quality of life.

Starting insulin pump therapy requires a specialist multidisciplinary team for selectionof patients for continuous subcutaneous insulin infusion, and to provide the on-goingeducation. Before starting pump therapy, patients should have participated in astructured group education programme whilst on multiple daily injections of insulin.

Once established, the use of additional technologies including continuous glucosemonitoring and the pump download facilities give significant added value to the clinicalcare of people with type 1 diabetes opting for this form of insulin delivery.

It is important that all patients with type 1 diabetes are made aware of thesetechnologies in diabetes care and, if appropriate, have access to them. Copyright © 2008John Wiley & Sons.

Practical Diabetes Int 2008; 25(3): 114–117

KEY WORDSinsulin pump therapy; patient selection; training; future technologies

David Kerr, MD, FRCPE, ConsultantPhysician Helen Nicholls, RGN, Diabetes NurseSpecialistJanet James, RGN, BNurs, HealthPromotion Specialist NurseBournemouth Diabetes and EndocrineCentre, Royal Bournemouth Hospital, and

Centre of Postgraduate Medical Researchand Education, Bournemouth University,Bournemouth, UK

*Correspondence to: Dr David Kerr,Consultant Physician, BournemouthDiabetes and Endocrine Centre, RoyalBournemouth Hospital, Castle Lane East,

Bournemouth BH7 7DW, UK; e-mail:david.kerr@rbch.nhs.uk

Received: 23 January 2008Accepted in revised form:19 February 2008

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• Improved quality of life. This is aconsistent and invariable benefitreported by patients switched fromMDIs to CSII. It is probably the most significant benefit reported bypatients moving onto CSII. However,many of the currently available toolsto assess formally this domain havemethodological problems makingjudgement about quality of life benefits difficult.9 Nevertheless, theBournemouth Impact of DiabetesScale has suggested that the overallburden of living with diabetes ismarkedly reduced by CSII.10,11

In Bournemouth, between 1998 and2003, patients were commenced oninsulin pump therapy as part of clin-ical trials or through self-funding. Atthat time, the concern was that thistype of therapy would only be avail-able to those who could afford it. In 2003, the National Institute for Clinical Excellence (NICE)reviewed the evidence for andagainst CSII.12 Their Final AppraisalDetermination stated that CSII isrecommended as an option for people with type 1 diabetes providedthat MDI therapy – including insulinglargine – has failed and that thosereceiving the treatment have thecommitment and competence to usethe therapy effectively.• Failure of MDI therapy wasdefined as: impossible to maintainHbA1c no greater than 7.5% withoutdisabling hypoglycaemia despite ahigh level of self-care. Disablinghypoglycaemia was defined as therepeated and unpredictable occur-rence of hypoglycaemia, requiringthird party assistance, that results in continuing anxiety about recur-rence and is associated with signifi-cant adverse effect on quality of life.• CSII should be initiated only by atrained specialist team which con-sists of a physician with a specialinterest in pump therapy, a diabetesnurse specialist and a specialist dieti-tian. We have established our pumpteam using this model.• People beginning insulin pumptherapy should be provided withtraining in its use, and on-going sup-port should be available to them. Aswell as traditional group educationfor patients commencing CSII, wealso have on-line learning (http://

www.b-dec.co.uk) and recently havedeveloped a home-based telehealthproject in conjunction with anindustrial partner.• These recommendations are alsoapplicable to children, adolescents,and pre-pregnant and pregnantwomen for whom MDI therapy isdeemed to have failed. We alsoreceive a number of referrals(10–15% of the total) from beyondour traditional catchment area and it is likely that this is going to increase.

Patient selection is critical to thedevelopment of an effective insulinpump service. All applications for thistechnology are reviewed by a consult-ant (DK) and diabetes specialistnurse (HN). If required, we also haveaccess to a clinical psychologist withan interest in diabetes within ourCentre. From the patient’s perspec-tive, he/she must:• Be motivated to succeed. • Have realistic expectations.• Be willing and able to monitor fingerstick blood glucose levels atleast four times daily.• Demonstrate self-managementskills.• Be aware of the nuances of carbo-hydrate counting and insulin doseadjustment.

In Bournemouth, the managementof type 1 diabetes involves flow-through structured education utilis-ing the skills of a multidisciplinaryteam with patients proceedingthrough well-defined steps beforeconsidering CSII. These comprise:• Home blood glucose monitoring.This is an essential component.Patients need to be educated aboutthe nuances of carbohydrate count-ing and insulin dose adjustment. • MDI therapy. This relates to theuse of basal and rapid-acting ana-logue insulins to reduce the risk ofhypoglycaemia, especially duringthe night.• Intensive education. This com-prises structured and quality assuredgroup education programmes, basedaround MDIs, which meet criteria aslaid down by NICE.13

• Injection sites. A problem withinjection sites remains despite theintroduction of insulin analogues

and, anecdotally, it is still a major fac-tor in sub-optimal glucose control. • Psychological barriers. There isincreasing evidence that psychologi-cal problems are important for manypatients with type 1 diabetes.14

• Glucose sensors.

In our clinical practice, devices forcontinuous interstitial glucose moni-toring have proved enormously ben-eficial in solving specific clinicalquestions, including the following.• Detection of hypoglycaemia withpost-hypoglycaemic hyperglycaemiaas a cause of sub-optimal glycaemiccontrol.• The elucidation of the cause ofnocturnal seizures in patients withinsulin-treated diabetes.• Determination of glycaemic excur-sions above and below ideal in indi-viduals with satisfactory HbA1c levels.• As a tool to examination the bene-fits (or otherwise) of a change fromMDIs to insulin pump therapy. • To look for hyperglycaemic peaksduring pregnancy.• As a research tool.

For most patients a traditional contin-uous glucose monitoring system isused with the information down-loaded in a specialist sensor cliniccomprising the patient (and rela-tive/carer), consultant, specialistnurse and dietitian. More recently, wehave started to use real-time monitor-ing which adds an extra dimension tointensive therapy for diabetes.15

Patient training for pumptherapyThis varies across the UK but allmethods are currently outpatientbased. Patients are only consideredfor CSII after they have participatedin one of the intensive training pro-grammes available for individualswith type 1 diabetes using MDIs (seehttp://www.b-dec.co.uk). The CSIIprogramme in Bournemouth con-sists of:• An initial assessment visit (consult-ant and specialist nurse).• A two-hour carbohydrate countingsession with the specialist dietitian.• A two-day group education sessionfor initiation of CSII. • Individual follow-up visits accord-ing to a structured pathway of care.

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Subsequently, patients are reviewedin a formal pump clinic where aphysician, diabetes specialist nurseand dietitian review them on thesame day. The clinic is structured to cover key areas of safety, educationand clinical effectiveness. The clinicalso includes the facility for computerdownloads of patients’ pump data.

Treatment with CSII can be haz-ardous and is thus contraindicatedin the following patients.• Those who are not motivated.• Those who do not perform homeblood glucose monitoring on a dailybasis.• Individuals with an unstable psyche. • Individuals with untreated pre-pro-liferative or proliferative retinopathy,as CSII may temporarily worsen theeye changes. Relative contraindica-tions also include severe end-stagediabetes complications, blindnessand where individuals lack supportfrom family and friends.

In addition, the BournemouthDiabetes and Endocrine Centre alsoruns regular structured programmeson CSII for health care professionalsfrom within the UK and fromabroad. We believe that our selec-tion process for CSII has been

robust, as indicated by a very lowpump discontinuation rate of <5%.However, following review of clinicaldata, it is clear that not all patientscontinue to benefit in the three keydomains of:• Reduced frequency of severe hypo-glycaemia and restoration of earlyhypoglycaemia warning symptoms.• Improvement in glycaemic controlas assessed by HbA1c levels.• Improved quality of life.

As a consequence, since 2005 allpatients have been required to agreeand sign an ‘agreement’ before com-mencing insulin pump therapy. Theaim of this is to highlight that CSIIhas a significant resource implica-tion, and that there are measurablebenefits from its use but this isdependent upon concordance. Theagreement is useful in highlightingthe relationship between costs ofinsulin pump therapy and measura-ble benefits, but it is not used as aformal (and therefore legally bind-ing) contract to terminate fundingfor CSII.

To date, locally, 112 (66 female)patients with a mean age of 45.51years (range 20–92) have been onpump therapy for an average of 3.4

years (range 0–9 years). Almost allpatients on pump therapy use rapid-acting insulin in their pumps.Changes in patients’ HbA1c andweight after one, two or three yearsare shown in Table 1.

One recent advantage reportedby our local population of pump-treated patients is the ability to perform multiple correction bolusesat any time using small amounts of insulin (data unpublished).Anecdotally, our own experience ofusing CSII in type 1 diabetes agreeswith published studies indicatingreduced rates of ketoacidosis andfew problems with infusion siteinfections, especially in children andyoung adults.4,16–17 Due to currentNICE guidelines we have little expe-rience with CSII in type 2 diabetes.

Future of insulin pumptherapyThe technologies available for dia-betes care continue to change at aremarkable rate. Pumps are likely tobecome smaller and lighter, includ-ing the possible use of disposable‘patch’ pumps which contain all ofthe usual features of CSII but have a pre-filled insulin containerincluded. In addition, the criteriafor offering CSII are likely tobroaden to perhaps include:• Patients with sub-optimal control,especially those with evidence ofearly microvascular complications.• Women with type 1 diabetes whoare planning pregnancy.• Patients with specific lifestyleneeds, including shift workers andathletes with type 1 diabetes.

CSII has been used elsewhere for themanagement of type 2 diabetes.Although theoretically attractive,adoption of this approach of insulindelivery in type 2 diabetes willrequire evidence from randomisedcontrolled clinical trials.

There is likely also to beincreased interest in developing less expensive and safer approachesto intra-peritoneal insulin adminis-tered by an external insulin pump.Although this represents a morephysiological approach to insulintherapy, there have been problemsrelated to infections and catheterocclusions. Implantable insulin

116 Pract Diab Int April 2008 Vol. 25 No. 3 Copyright © 2008 John Wiley & Sons

Table 1. Change in HbA1c and weight (mean [SD])

HbA1c (%) Weight (kg)

Commencing pump 8.73 [1.41] 73.29 [12.35] n=105 n=96

1 year 8.01 [1.21] 72.87 [12.74] n=76 n=69

2 years 8.05 [1.10] 74.45 [13.59] n=73 n=62

3 years 7.96 [1.19] 74.16 [11.61] n=54 n=51

Mean change after 1 year -0.66 (0.38; 0.93) +1.05 (-0.17; 2.27)(95% CI) p<0.001 p=0.093

n=71 n=60

Mean change after 2 years -0.60 (0.30; 0.89) +1.96 (0.61; 3.31)(95% CI) p<0.001 p<0.01

n=68 n=57

Mean change after 3 years -0.46 (0.14; 0.78) +1.31 (-0.86; -3.49)(95% CI) p<0.005 p=0.229

n=52 n=48

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Pract Diab Int April 2008 Vol. 25 No. 3 Copyright © 2008 John Wiley & Sons 117

pump therapy has also been limitedbecause of expense. It is anticipatedthat the costs of CSII and glucosesensing may fall in the not-too-distantfuture as many more companiesbring their wares to the marketplace.

The ‘holy grail’ of this type ofapproach to the management oftype 1 diabetes is the concept of aclosed loop system including aninsulin pump and a glucose sensor.With the introduction of combinedpumps and sensors, this is hopefullygoing to become a reality soonerrather than later. Meanwhile, otherexamples of current good practicein this area can be found in the UKDepartment of Health report of theInsulin Pumps Working Group.18

Conflict of interest statementDK and HN have received honorariafor participation in educationalmeetings supported by Medtronicand Roche.

References1. The Diabetes Control and

Complications Trial Research Group.

The effect of intensive treatment ofdiabetes on the development andprogression of long-term complica-tions in insulin-treated diabetes mel-litus. N Engl J Med 1993; 329:977–986.

2. The Diabetes Control andComplications Trial Research Group.Implementation of treatment proto-cols in the Diabetes Control andComplications Trial. Diabetes Care1995; 18: 361–376.

3. Pickup J, Mattock M, Kerry S.Glycaemic control with continuoussubcutaneous insulin infusion com-pared with intensive insulin injec-tions in patients with type 1 diabetes:Meta-analysis of randomised controltrials. BMJ 2002; 324: 705–708.

4. Weissberg-Benchell J, Antisdel-Lomaglio J, Seshadri R. Insulin pumptherapy: a meta-analysis. Diabetes Care2003; 26: 1079–1087.

5. Rodrigues I, Reid H, Ismail K, et al.Indications and efficacy of continu-ous subcutaneous insulin infusiontherapy in type 1 diabetes mellitus; aclinical audit in a specialist service.Diabetic Med 2005; 22: 842–849.

6. Chantelau E, Spraul M, MuhlhauserI, et al. Long term safety, efficacy andside-effects of continuous subcuta-neous insulin infusion for type 1 dia-betes mellitus: a one centre experi-ence. Diabetologia 1989; 32: 421–426.

7. Linkeschova R, Raoul M, Bott U, etal. Less severe hypoglycaemia, bettermetabolic control and improvedquality of life in type 1 diabetes mel-litus with continuous subcutaneousinsulin infusion (CSII) therapy: anobservational study of 100 consecu-tive patients followed for a mean of2 years. Diabetic Med 2002; 19:746–751.

8. Gimenez M, Conget I, Jansa M, et al.Efficacy of continuous subcutaneousinsulin infusion in type 1 diabetes: a2-year perspective using the estab-lished criteria for funding from aNational Health Service. Diabetic Med2007; 24: 1419–1423.

9. Barnard KD, Lloyd CE, Skinner TC.Systematic literature review: qualityof life associated with insulin pump

use in type 1 diabetes. Diabetic Med2007; 24: 607–617.

10.Everett J, Kerr D. Measuring theimpact of type 1 diabetes from thepatient’s perspective. J DiabetesNursing 2005; 9: 186–190.

11.Kerr D, Everett J. Continuous subcu-taneous insulin infusion (CSII), a UKperspective. Infusystems Int 2002; 1:2–3.

12.National Institute for ClinicalExcellence. Guidance on the use of con-tinuous subcutaneous insulin infusionfor diabetes. Technology AppraisalGuidance No. 57. National Institutefor Clinical Excellence: Feb 2003.

13.National Institute for ClinicalExcellence. Diabetes (types 1 and 2)patient education models. TechnologyAppraisal Guidance No. 60. NationalInstitute for Clinical Excellence, May2003.

14.Shaban C, Fosbury J, Kerr D, et al.The prevalence of depression andanxiety in adults with type 1 diabetes.Diabetic Med 2006; 23: 1381–1384.

15.Deiss D, Bolinder J, Riveline J, et al.Improved glycaemic control inpoorly controlled patients with type 1diabetes using real-time continuousglucose monitoring. Diabetes Care2006; 29: 2730–2732.

16. Jakisch BI, Wagner VM, HeidtmannB, et al. Comparison of continuoussubcutaneous insulin infusion (CSII)and multiple daily injections (MDI)in paediatric type 1 diabetes: a multi-centre matched-pair cohort analysisover 3 years. Diabetic Med 2008; 25:80–85.

17.Linkeschova R, Raoul M, Bott U, et al.Less severe hypoglycaemia, bettermetabolic control, and improvedquality of life in Type 1 diabetes mel-litus with continuous subcutaneousinsulin infusion (CSII) therapy; anobservational study of 100 consecu-tive patients followed for a mean of 2years. Diabetic Med 2002; 19: 746–751.

18. Insulin pump services: Report of theInsulin Pumps Working Group. London:Department of Health, March 2007.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_072777

Key points

• Insulin pump therapy is ofconsiderable value to carefullyselected individuals with type 1diabetes

• Before commencing CSII, adultpatients should have participatedin a structured group educationprogramme focusing on thenuances of intensive insulintherapy

• In addition to CSII per se, theavailability of continuous glucosemonitoring systems and pumpdownload facilities addssignificant value for both themultidisciplinary specialist teamand patients

CONFERENCE NOTICE

5th World Congress on Prevention of Diabetes and its Complications1–4 June 2008, Helsinki, Finland

For further details and to register please contact: WCPD 2008, c/o Congrex, PO Box 81, FIN-00371 Helsinki, Finland. Tel: +358 9 560 7500, fax: +358 9 5607 5020, e-mail: wcpd2008@congrex.fi, website: www.wcpd2008.fi

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