Importanza della scelta del device nella somministrazione ... · La Dott.ssa Uliana Ambra dichiara...

Importanza della scelta del device nella somministrazione della terapia insulinica

Dott.ssa Ambra UlianaPadova

La Dott.ssa Uliana Ambra dichiara di NON aver ricevuto negli ultimi due anni compensi o

finanziamenti da Aziende Farmaceutiche e/o Diagnostiche

Dichiara altresì il proprio impegno ad astenersi, nell’ambito dell’evento, dal nominare, in qualsivoglia modo oforma, aziende farmaceutiche e/o denominazione commerciale e di non fare pubblicità di qualsiasi tiporelativamente a specifici prodotti di interesse sanitario (farmaci, strumenti, dispositivi medico-chirurgici, ecc.).

Agenda

• Grado di “Aderenza” nel diabete di tipo 1 e 2• Bassa aderenza e controllo glicemico• Fattori che influenzano l’aderenza• Come migliorare l’aderenza• Conclusioni

Grado di “aderenza”

nel diabete di tipo 1 e 2

Internet survey 502 US adults on insulin (114 DM1 e 388 DM2)

AIM: to evaluate rate e factors associated with insulin omission

How often do you skip insulin injection that you know you should take?

57% omitted insulin intentionally20% omitted insulin frequently

Peyrot M et al. Diabetes Care 33:240–245, 2010

Correlates of insulin injectionsomission

33.2% of patients reported insulin omission/non adherence at least 1 day in the last month.

Insulin adherence behaviours and barriers in the multinational global attitudes of patients and physicians in insulin therapy study

Peyrot M et al. Diabet. Med. 29, 682–689 (2012)

Internet or telephone survey 1250 physicians 1530 patients (180 type 1 and 1350 type 2)(China, France, Japan, Germany, Spain, Turkey, UK, USA)

72.5% of physicians report that their typical patient does not take their insulin as prescribed.

Bassa aderenzae controllo glicemico

A Review of Diabetes Treatment Adherence and theAssociation with Clinical and Economic Outcomes

Asche C et al. Clinical Therapeutics/Volume 33, Number 1, 2011

37 articles (25 on T2D, 7 about insulin)

Conclusions: Based on the literature, better adherence was found to be associated with improved glycemic control and decreased health care resource utilization.There was no consistent association between improved adherence and decreased health care costs.Little data were available on the association between adherence and quality of life.

Depending on the study, for every 10% increase inadherence there were corresponding 0.1% to 0.0014%decreases in A1C

The Influence of Insulin Use on Glycemic Control

Adults used 77% of prescribed amounts of insulin….

Cramer JA et al. Diabetes Care 28:78-83, 2005

How well do adults follow prescriptions for insulin?

→ HbA1c higher than the recommended level

6,222 veterans T2DM,tretaed with insulin. The rate of insulin use during a 2-year period (using pharmacy data)

Una bassa aderenza influenza molto l’efficacia del trattamento prescritto!

L’aderenza terapeutica (MPR) è il principale predittore di deterioramento del controllo metabolico nel tempo

Egede LE, et al. Annals of Pharmacotherap 2014, Vol. 48(5) 562–570

Longitudinal Effects of Medication Nonadherence on Glycemic Control

11 272 veterans with type 2 diabetes followed from April 1994 to May 2006

mean A1C decreased by 0.24 (p < 0.001) for each 10% increase in MPR

Primary outcome measures: mean glycosylated hemoglobin and proportion in poor control (A1C > 8%) over time

MPR, sociodemographics, medical and psychiatric comorbidities

Bassa aderenza e morbilità/mortalità

The Impact of Treatment Non-Compliance on Mortality in People With Type 1 Diabetes

Currie CJ et al. Diabetes Care 35:1279–1284, 2012Currie CJ et al. J Diabetes Complications. 2013 May-Jun;27(3):219-23

THIN database UK (> 350 primary care)

2946 DM1: 29.4% non compliant (appointment and medication)

Treatment non-compliance was associated with increased all-cause mortality in patients with type 1 and 2 diabetes.

15,984 DM2: 39.0% missed at least one scheduled appointment; 4,4% noncompliant with medication

Association Between Adherence to Pharmacotherapy and Outcomes in Type 2 Diabetes: A Meta-analysis

Khunti K et al. Diabetes Care 2017

- 28% Death

Good Adherence Poor Adherence

Association between medication adherence and all-cause hospitalization in type 2 diabetes.

-10% hospitalization

Fattori che influenzano l’aderenza

Key factors that affect medication adherence

• Socioeconomic factors• Heath care system-related factors• Concomitant illness• Therapy-related factors• Patient related factors

Ferdinand KC et al. J Am Coll Card 2017, 69, 437-451

Key-factors affecting adherence (1)

1 - Socio-economic Factors

Low health literacy

Lack of family or social support

Unstable living conditions/homelessness

Limited access to health care facilities

Difficulty accessing pharmacy

Cultural and lay beliefs about illness and treatment

Nielsen NF et al. Diabetes Care 2019;42:1398–1405

Socioeconomic inequality in metabolic control among children with type 1 diabetes:

a nationwide longitudinal study of 4,079 Danish children

Socio-economic, demographic, and clinical correlates of poor glycaemic control within insulin regimens among children with Type 1 diabetes:

the SEARCH for Diabetes in Youth Study

Snyder LL et al. Diabet Med. 2019 Aug;36(8):1028-1036

N=1095 children with T1D aged 10-17 years694 on insulin pump therapy, 188 receiving basal-bolus injections, and 213 on a mixed insulin regimen.

Family conflict between parent and child regarding DM management wasthe only factor significantly associated with poor glycaemic control in all insulin

regimens (insulin pump, P≤ 0.0001; BB injections, P=0.0002; mixed insulin regimen, P=0.0103).For children on insulin pump, poor control was significantly associated withnon-white race (P=0.0008), living in multiple households (P=0.0331),having Medicaid insurance (P=0.0090), and decreased insulin adherence (P<0.0001).

Ferdinand KC et al. J Am Coll Card 2017, 69, 437-451

Key-factors affecting adherence (2)

2 - Health care system related factorsProvider-patient relationship

Provider communication skills

Disparity between health beliefs of patient and provider

Lack of positive reinforcement from provider

Weak system capacity for patient education

Lack of knowledge about adherence and interventions for improving it

Patient information materials written at too high of a literacy level

Long wait times and lack of continuity of care

Exploring the role of the patient-physician relationship on insulin adherence and clinical outcomes in type 2 diabetes:

Insights from the MOSAIc study

Linetzky B et al. Journal of Diabetes 9 (2017), 596–605

How patient perception of care affects distress status, insulin adherence, and the relationshipwith clinical outcomes?

4341 patients with T2D taking insulin

*Multinational Observational Study assessing Insulin use

Key-factors affecting adherence (2)

Ferdinand KC et al.J Am Coll Card 2017, 69, 437-451

3 – Medical conditionrelated factors

4 – Therapyrelated factors

Chronic conditions Complexity of medication regimen

Lack of symptoms Treatment requires mastery of certain techniques (eg.: injection; CGM; pump)

Severity of symptoms Duration of therapy

Depression Frequent changes in medication regimen

Psychotic disorders Lack of immediate therapeutic benefit

Mental retardation Medication with associated social stigma

Development disability Actual/perceived unpleasant side effects

Treatment interferes with lifestyle or requires significant behavioural change

Possibili problemi psicologici coinvolti nella scarsa aderenza

• Paura dell’ipoglicemia • Aspettative non realistiche • Scarsa accettazione della pompa • Disgusto nel dipendere da una macchina • Sfiducia nel valore di glicata come misura di successo. • Mancanza di motivazione • Locus of control esterno elevato, approccio passivo al

diabete

Key-factors affecting adherence (2)

Ferdinand KC et al.J Am Coll Card 2017, 69, 437-451

3 – Medical conditionrelated factors

4 – Therapyrelated factors

Chronic conditions Complexity of medication regimen

Lack of symptoms Treatment requires mastery of certain techniques (eg.: injection; CGM; pump)

Severity of symptoms Duration of therapy

Depression Frequent changes in medication regimen

Psychotic disorders Lack of immediate therapeutic benefit

Mental retardation Medication with associated social stigma

Development disability Actual/perceived unpleasant side effects

Treatment interferes with lifestyle or requires significant behavioural change

Cryer PE. N Engl Med 2013, 369, 362-372

IPOGLICEMIA

Key-factors affecting adherence (2)

Insulin adherence in patients with diabetes: risk factors for injection omission.

251 T1D, 257 T2D, QuestionnairesMost commons barriers

• Injection site reactions (90,2%)• Fear of hypoglycemia (87.4%)• Injections being time consuming (63.2%)• Interference with physical activity (61.6%)• Lack of adequate injection instructions (59.6%)

Farsaei S,et al. Prim Care Diabetes 2014;8:338–345

Internet survey 502 US adults on insulin(DM1 e DM2)

AIM: to evaluate rate and factors associatedWith insulin omission

How often do you skip insulin injectionThat you know you should take?

57% omitted insulin intentionally20% omitted insulin frequently

Peyrot M et al. Diabetes Care 33:240–245, 2010

Correlates of insulin injections omissionDemographic and disease factors• younger age, • lower income,• type 2 diabetes, • not following a healthy diet,

Insulin and injection-related factors• taking more daily injections,• interference of injections with daily activities, • injection pain and embarrassment.

Peyrot M et al. Diabetes, Obesity and Metabolism 14: 1081–1087, 2012.

Factors associated with injection omission/non-adherence in the global attitudes of patients and physicians in Insulin

therapy study

Multinational survey on 1530 subjects on insulin therapy( China, France, Japan, Germany, Spain, Turkey, UK or USA)

Mean age 60 yrs, >9 yrs insulin,15 yrs diabetes duration

35% non adherent(differences in different Countries)

Psychosocial/Behavioural Factors• Worse scores for non-medication regimen

adherence• Insulin regimen adherence perceived as not

important• Injections perceived to affect lifestyle

• More difficulty with injection tasks• More barriers to insulin adherence• Less Satisfaction with the flexibility of the

timing of insulin injections

Come migliorare l’aderenza?

LA TECNOLOGIA

Bluetooth-enabled pen capReal-time CGMElectronic tools for the monitoring of therapeutic approachesAutomated bolus calculators for insulinElectronic tools for education and information of patientsCSIITelemedicine

• In soggetti con DM1 selezionati che presentano HbA1c persistentemente superiore al target desiderabile per il paziente nonostante MDI ottimizzata (1A)

• Ipoglicemia ricorrente, grave o notturna (1A)

RACCOMANDAZIONI

I: più studi clinici controllati randomizzati e/o revisioni sistematiche di RTA: fortemente raccomandato

Quale microinfusore scegliere

Caratteristiche metaboliche• fabbisogno insulinico (capacità del serbatoio)• necessità di CGM (sistema integrato/associato)• necessità di PLGS/HCL

Caratteristiche del paziente• abilità tecnologica e di apprendimento• esigenza di privacy (dimensioni del device,

catetere/patch, controllo esterno della pompa)• scelta personale

Controindicazioni a CSII

• Non aderenza alla terapia (incapacità a mantenere unregolare follow-up ambulatoriale, con regolari visiteperiodiche; periodi prolungati di assenza dai controlliclinici, inadeguata esecuzione dell’autocontrolloglicemico, con almeno 3 misurazioni/die)• Scarsa aderenza alla dieta, alle regole relative allo stiledi vita• Rifiuto dello strumento• Incapacità nella gestione dello strumento• Mancata motivazione ad ottenere una ottimizzazionedel controllo• Deficit visivi gravi/cecità• Disturbi psichiatrici

Hendrychova et al. Patient Prefer Adherence. 2013 Sep 2,7

The adherence scores did not differ between the CSII and MDI patients

Strong correlation between frequency of self-monitoring of before meal BG and adherence

Adherence in adults with type 1 diabetes mellitus correlates with treatment satisfaction but not with

adverse events

Self-care adherence is associated with treatment satisfaction in adult patients with type 1 diabetes

Deeb et al. Clin Diabetes and Endocrin 2019, 5:7

Switching young T1DM patients from MDI to a remote control-integrated pump system achieved a reductions in HbA1c and insulin dose.

Positive attitude towards remote operating enhanced these effects.

Patient satisfaction was markedly improved.

Using insulin pump with a remote-control system in young patients with diabetes improves glycemic

control and enhances patient satisfaction

Munshi MN et al. Diabetes Care 2019; 42:1129–1131

Nonadherence to insulin therapy detected by Bluetooth-enabled pen cap is associated with poor

glycemic control

85% dose adherence 49% dose adherence

75 participants with diabetes, 42 younger (29 ± years) and 33 older (73±7 years).Follow-up: 1 month

The role of insulin pump therapyfor type 2 diabetes mellitus

• Predictable absorption of basal insulin• Better treatment satisfaction• Potential of less insulin omissions• Better assessment of insulin use by health care

providers

Landua Z et al. Diabetes Metab Res Rev 2017; 33: e2822.

Why might CSII work better than MDI injections in T2DM?

Glycemic Control During Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Insulin Injections in Type 2 Diabetes: Individual Patient Data Meta-analysis and Meta-regression of Randomized Controlled Trials

Pickup JC et al, Diabetes Care 2017

DMT2: MDI 287, CSII 303.Con CSII

Glicata ↓ 0.4%UI/Kg die ↓ 0.25 %Peso (Kg) non varia

Alcune delle patch pumps disponibili o in fase di sviluppo per il diabete di tipo 2

Pompe più semplici, più facili da usare, più economiche

In conclusion, rather than assuming that an intervention by a health professional discussing adherence to insulin actually improves adherence to insulin, long-term studies investigating this are required.

Drugs don’t work in patients who don’t take them”

Need for personalized care:the benefits vs risks of diabetes therapy bust be assessed for each patient

When metabolic control is deranged, always think about poor adherence!

Un approccio incentrato sul paziente facilita l’identificazione delle eventuali preferenze, aspettative che possono motivare il paziente

a fare la terapia migliorando in maniera significativa l’aderenza

Grazie per la vostra attenzione!