General Practice and Primary Health Care Academic Centre

Enhanced General Practice Management of DiabetesStarting insulin in general practice

Jo-Anne Manski-Nankervis

Louise Ginnivan

What we are going to cover tonight

• Evidence and rationale for use of insulin in T2D and current clinical guidelines

• Self monitoring, goal setting and common patient concerns

• Familiarisation with insulin and dose adjustment

• Case studies and questions

Evidence and rationale for use of insulin in type 2 diabetes and current guidelines

Type 2 diabetes: The scope of the problem

• Prevalence– ~1 million Australians have T2D– ~280 Australians develop T2D every day– Up to 60% of cases can be prevented

• Complications– Microvascular and macrovascular– 65-80% of people with diabetes will die of

coronary heart disease• Financial costs

– T2D costs Australia $3 billion/year

Rationale for Treating to Target

UKPDS:

• Tight glycaemic control reduces micro (and macro) vascular complications1

• 1% reduction in HbA1c→ 21% ↓ diabetes endpoint, 21% ↓ diabetes related death, 14% ↓ AMI, 37% ↓ microvascular complications

• Metabolic memory2

• Tight control early in diabetes results in continued reduction microvascular risks, AMI and death even if glycaemic control deteriorates later

1 Stratton et al (2000), BMJ 321:405-4122 Holman et al (2008), N Engl J Med 359:1577-89

ADS recommended targets.

General Target ≤ 7% (53mmol/mol)

Specific Situations

DM:

•short duration •no CV Disease

Managed with lifestyle +/- metformin

≤ 6%

(42mmol/mol)(risk of hypos permitting)

Managed with any other OHA (not metformin or insulin)

≤ 6.5% (48mmol/mol)

Managed with insulin ≤ 7%(53mmol/mol)

Pregnancy or planning a pregnancy

≤ 6%(42mmol/mol)

DM of longer duration (> 10-20 years) or has CV disease

Any form of therapy ≤ 7%(53mmol/mol)

Recurrent severe hypo or hypo unawareness

Any form of therapy ≤ 8%(64mmol/mol)

Patients with major co-morbidities likely to limit life expectancy

Any form of therapy Symptomatic therapy

Wah Cheung et al (2009) MJA 191(6):339-344

Depiction of the elements of decision making used to determine appropriate efforts to achieve glycemic targets.

Inzucchi S E et al. Dia Care 2012;35:1364-1379

Copyright © 2011 American Diabetes Association, Inc.

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Insulin

“We have obtained from the pancreas of animals a mysterious something which injected into totally diabetic dogs completely removes all the cardinal symptoms of the disease...If the substance works on the human it will be a great boon to medicine”

JB Collip, 8 January, 1922

Relationship between insulin resistance,

insulin deficiency and glycaemia

Relative insulin deficiency starts

Eventual absolute insulin deficiency

IR not increasing

PP BGL is the first abnormality

Antihyperglycemic therapy in type 2 diabetes: general recommendations. (ADA/EASD)

Inzucchi S E et al. Dia Care 2012;35:1364-1379

Copyright © 2011 American Diabetes Association, Inc.

RACGP Guidelines

RACGP Guidelines 2014

Reproduced with permission from The Royal Australian College of General Practitioners from: General practice management of type 2 diabetes. Melbourne: RACGP, 2014.

Treating to target and starting insulin

• Good glycaemic control reduces micro (and macro) vascular complications BUT about half our patients are not well controlled

• Lifestyle + OHA + insulin most validated pathway

• “Therapeutic inertia” and barriers to insulin initiation

• Mean HbA1c prior to insulin initiation: 9.4% (Fremantle Study, Davis et al 2006)

• Patient, doctor and system level

0

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10

15

20

25

30

35

40

45

5045.1

21.7 21.7

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SpecialistsPrimary care physicians

Prop

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p=0.2p=0.7

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Clinical inertia in response to inadequate glycaemic control: Do specialists differ from primary care physicians?

Should we be commencing insulin in general practice?

• There is a relative lack of access to specialists

• Benefits of continuity of care and accessibility

• Insulin initiation in general practice is safe1,2

• Practice nurses and CDEs can take the lead for this with adequate training and support (UK, Netherlands)

Endocrinologist 1:2000

Practice nurse1:125

CDE-RN1:630

GP 1:47

1 Davies et al (2007) Diabetes Obesity & Metabolism 9(5):706-13.2 Samann et al. (2013) Family Practice 30(3):290-3.

Who might benefit from initiation of insulin?

Strong indications for insulin therapy include:

• HbA1c for ≥ 7.5% (58mmol/mol) for more than 3 months

• Maximum oral therapy yet control not ideal

• Oral hypoglycaemic treatments not tolerated or contraindicated

Goal setting and common patient concerns

Case study

Brian: 61 year old electrician

PMH: • Hypertension (controlled), Hypercholesterolaemia • Type 2 diabetes diagnosed 8 years ago

Medications• ACE inhibitor and low-dose thiazide• Atorvastatin (40 mg daily)• Metformin (1000mg bd) and Glibenclamide (10mg bd)

Lifestyle• Stopped smoking 10 years ago; gave up alcohol 12 months ago• Physically unfit and inactive.

Pathology and anthropometric measures• Slowly gaining weight, despite diet and exercise advice, BMI 34 kg/m2, WC 104 cm• A1C now stable, ~ 8.5% (69mmol/mol). Does not self-monitor blood glucose levels

What would you do in this case: Lifestyle? Other oral agents? Insulin? Other medications?

What if: HbA1c 7.5% (58mmol/mol)? He was aged 45? Or 80? HbA1c 11.6% (103mmol/mol)?

Barriers to insulin initiation

Patient factors Physician factors -These are likely to apply to nurses too!

Belief that diabetes is not a serious illness Fear of addiction Belief that insulin makes patient fat Fear of hypoglycaemia Belief that insulin would not help Pain associated with insulin injection Other fears regarding injection of insulin Pain associated with blood tests Lack of faith in doctor Anxiety Concern that can never stop insulin Life will be restricted as a result of starting insulin Belief that insulin causes problems like blindness Non-compliance with medical appointments Non-compliance with medications

Belief that patient wouldn’t comply with treatment Fear of hypoglycaemia in a specific patient Belief that patient couldn’t cope with pain involved in

insulin injection Patient too old or inadequate level of education No experience with treatment Not wanting to give to obese patients because insulin

would result in further weight gain Belief that a specific patients diabetes is so severe that

even insulin wouldn’t help Lack of resources in office based practice – drug cost, staff

availability, skills of staff, time Belief that insulin initiation is complex Lack of motivation to improve clinical practice Belief that insulin would impair patient quality of life Patient co-morbidities

Talking about insulin

Brian presents with his wife, who is very keen for him to improve his health. She has a little knowledge of diabetes. They are aware you have recommended starting insulin. Brian’s wife asks what they have done wrong in trying to control his blood glucose level, and what the future holds for him. “Is it our fault?” she asks

How do you respond?Brian isn’t sure that he wants to go on insulin

“Are we Dancing or Wrestling?”

Ambivalence

•Wanting and not wanting to change, being ‘stuck.’

•Normal, common, powerful

Making assumptions about change

•This person ought to change, wants to change

•This person is primarily motivated by their health

•People are either motivated to change or not

•A tough approach is always best, I’m the expert. They ought to follow my advice

Readiness

1 2 3 4 5 6 7 8 9 10

Importance “Do I want to change?”

10

9

8

7

6

5

4

3

2

1

Confidence “Can I change?”

Importance-confidence-readiness

Express Empathy – Ambivalence is normal.

Understand the patients perspective

• Develop Discrepancy– Importance/confidence ruler– Change talk

• Roll with resistance– Reframe patient concerns

positively, – Avoid confrontation– Emphasize personal choice and

control• Support Self-Efficacy

– Belief in the ability to change is an important motivator

Principles of motivational interviewing

Change talk• Problem Recognition“What things may happen if your diabetes remains as

poorly controlled as this?”• Intention to change and optimism about

change:“What might be some of the advantages in going on

to insulin?”“Who are the people in your life that would support

you in making the change to insulin?”“If we were to bump into each other on the street in

six months time, what do you think you would you like to tell me about your diabetes and how you are managing it? …how would you like things to turn out?”

Familiarisation with insulin, dose adjustment and blood glucose monitoring

What are the types of insulin?

Brian decides to give insulin a try.

What options are available?

Insulin time-action profiles

12 242 4 6 8 10 14 16 18 20 22 hours

12 242 4 6 8 10 14 16 18 20 22 hours

Phillips LK & Phillips PJ, 2006; Profiles adapted from Clinical Practice Guidelines: Type 1 Diabetes in Children and Adolescents by Australian Paediatric Endocrine Group. p58

#20/80 and 30/70 short/intermediate-acting also available *25/75 rapid/intermediate-acting also available. Accessed at http://www.nhmrc.gov.au/publications/synopses/_files/cp102.pdf on November 19, 2007

12 242 4 6 8 10 14 16 18 20 22 hours

Rapid acting analogue

Basal analogue (insulin glargine)

30% rapid-acting & 70% intermediate-acting analogue insulin

Insulin Regimens

• BD pre-Mix:

• Basal:

• Basal+1:

• Basal Bolus

Patient benefits of analogue insulin

Rapid acting analogues:• insulin lispro (Humalog); insulin aspart (Novorapid); insulin glulisine

(Rapid acting insulin analogue)• Major advantages:

• Inject and eat (no need to inject 30 minutes prior to meal)• Lowered hypoglycaemic risk compared to insulins with ‘longer

tails’

Basal analogues:• insulin glargine (Lantus); insulin detemir (Levemir)• Major advantage is reproducible profile

• less “hypos”• Less impact on weight gain• Significant improvements in health related Quality of Life

measures• Once-daily dosing possible in most people, especially with

glargine

Phillips LK & Phillips PJ, 2006; Hirsch I, 2005; Fischer JS, 2004; Rosenstock J,2005; Janka HU, 2005; Phillips PJ, 2006; Phillips PJ, 2007.

What is required to start insulin in general practice?

• Equipment • Education• GP and PN/CDE willing to work with

each other• In practice protocol• Expert back up and local referral

networks eg. CDE, endocrinologist

• Confidence!

What’s involved?: Getting started on Glargine (Lantus)addressing fasting glucose levels

GP and PN baseline visit

PN Baseline

visit 2 (next day)

Titration calls or F-F

with PN

PN Reminder

call

GP and PN Week 4 visit and monthly

thereafter

Timeline

Tasks: GP assesses need for insulin and documents plan to use protocol. PN gives first Lantus dose

Tasks: PN watches patient give their own dose, check technique etcBASAL TITRATION TOOL

0 0+1 day

Weeks 1-3

3 4, 8, ...

FBGLs 4 - 7.0 consistently

Decision made to consider

Rapid acting insulin

analogue

Tasks: PN and GP liaise, review and decision to start Rapid acting insulin analogue

Tasks: PN works with patient to up-titrate, liaison with GP and DNE/Endo as needed

Tasks: PN reminds patient re next weeks visit

Tasks: GP and PN clinical review

X

Target Fasting glucose levels: 4-7mmol/L

Case study

Brian: 61 year old electrician

Visit 1: GP• GP reviews glycaemic control and confirms the need to start

insulin• Provide script for insulin glargine• Record in notes directions for practice nurse/CDE to utilise

practice protocol for initiation of insulin• Notify VicRoads of commencement of insulin• Update NDSS registration

Lantus Initiation

• The patient is NOT to be started on glargine unless they have demonstrated that they are able to monitor their blood glucose levels reliably.

• The starting dose of glargine is to be 10 units once daily preferably in the evening.

• The Solostar disposable pen or cartridge can to be used.• Both timing of and dose of Lantus can be modified at the discretion of

the general practitioner.• The patient is to return the next day so that self-administration of the

second injection can be observed.

Case study

Brian: 61 year old electrician

Visit 1: PN/CDE• Demonstration of insulin pen• How to prevent, treat and recognise hypos• Sick day management• Healthy diet and lifestyle• Give sharps container/refer to Diabetes Australia for sites• Ensure patient monitors with BGL machine twice per day• How to give insulin and importance of site rotation• GIVE/INSTRUCT PATIENT TO ADMINISTER 10 UNITS

INSULIN• Storage of insulin• Sharps disposal • Insulin dose and administration time• Arrange next day visit: pt to give insulin under supervision

What’s involved?: Getting started on Glargine (Lantus)addressing fasting glucose levels

GP and PN baseline visit

PN Baseline

visit 2 (next day)

Titration calls or F-F

with PN

PN Reminder

call

GP and PN Week 4 visit and monthly

thereafter

Timeline

Tasks: GP assesses need for insulin and documents plan to use protocol. PN gives first Lantus dose

Tasks: PN watches patient give their own dose, check technique etcBASAL TITRATION TOOL

0 0+1 day

Weeks 1-3

3 4, 8, ...

FBGLs 4 - 7.0 consistently

Decision made to consider

Rapid acting insulin

analogue

Tasks: PN and GP liaise, review and decision to start Rapid acting insulin analogue

Tasks: PN works with patient to up-titrate, liaison with GP and DNE/Endo as needed

Tasks: PN reminds patient re next weeks visit

Tasks: GP and PN clinical review

X

Target Fasting glucose levels: 4-7mmol/L

Case study

Brian commences the 10 units of glargine and demonstrates

good injection technique.

His dose now needs to be titrated.

Tools for insulin titration:• Accu-Chek 360 basal insulin titration tool• RACGP Guidelines now contain algorithms for

titration of basal, mixed and prandial insulins.

Options:• Health professional led titration OR• Patient self titration

Guidelines provide HbA1c, FBG and PPBG targets

Normal Targets for diabetes patients

ADS/EASD AACE IDF Stepping Up study

HbA1c <6.0 <7.0 <6.5 <6.5 <7.0

FBGL <5.5 3.9-7.2 <6.0 <6.0 4.0 - 7.0

PPBGL2 hours postprandial

<7.8 <10 <7.8 <8.0 4.5 - 10.0

Stepping Up protocol for adjustment of glargine

Case study

Brian: 61 year old electrician

Brian has been stabilised on a dose of 44 units of glargine and his fasting blood glucose levels are consistently in the target range of 4-7mmol/L. His HbA1c has improved from 8.5% (69mmol/mol)to 7.5% (58mmol/mol).

What is the next step?

GP and PN insulin visit (with Study

DNE prn)

Titration calls or F-F

with PN

PN Reminder

call

Tasks: GP review, discussion with patient, PN review and education in use of RAPID ACTING TITRATION TOOL

X X+1 Weeks X + 1-3 X+3

FBGLs 4 -7 .0 consistently

Decision made to consider

rapid insulin

Tasks: PN and GP liaise, review and make decision to start Rapid acting insulin analogueSee patient and do 3 DAY PROFILE

GP and PN Week 4 visit and monthly

thereafter

PPBGLs 4.5 - 10.0

consistently

Tasks: Ongoing clinical monitoring

X+4, 8, ...

Target Post-Prandial Glucose levels: 4.5-10mmol/L

Tasks: PN works with patient to up-titrate, liaison with GP and DNE/Endo as needed

Tasks: PN reminds patient re next weeks visit

Tasks: GP and PN clinical review

Timeline

What’s involved?: Starting Rapid acting insulin analogue (Rapid acting insulin analogue: Apidra/Novorapid/Humalog) addressing 2hr post-prandial glucose levels

Rapid acting insulin analogue Initiation

• Rapid acting insulin analogue can be initiated at any time after the patient has been on Lantus for 4 weeks.

• Fasting blood glucose levels should be in target range prior to Rapid acting insulin analogue initiation.

• Identify the meal with the highest post-prandial glucose readings. If above target (>10.0mmol/L) a pre-meal injection of Rapid acting insulin analogue should be initiated.

• The Solostar injecting device for Rapid acting insulin analogue is identical to that used for Lantus, except for pen colour .

• Starting dose 4 Units immediately prior to designated meal

Determining which meal to target: 3 day 7 point profile

Stepping Up protocol for titration of rapid acting insulin analogue

Some notes on blood glucose monitoring

Why test?

• SMBG allows patients to evaluate their individual response to therapy and assess whether glycaemic targets are being achieved.

• Results of SMBG can be useful in preventing hypoglycaemia and adjusting medications (particularly insulin doses).

• SMBG allows clinicians to compare HbA1c derived average glucose estimation with actual BGLs from patients and make decisions on therapy changes and interventions.

Top 10 reasons patients give for not testing.1

1. The meter makes me feel bad about myself

2. Monitoring seems pointless (because there is nothing I can really do about my blood glucose results anyway).

3. Checking blood glucose reminds me that I have diabetes – 24/7

4. The meter seems to control my life, telling me what I can and cannot do.

5. Monitoring serves as an opportunity for friends and family to bother me

6. None of the health care providers ever do anything with the results anyway.

7. Checking blood glucose sometimes hurts.

8. Monitoring can be inconvenient.

9. Monitoring can be expensive.

10. Life is too busy and demanding to take the time for regular monitoring.

1. William Polonsky, "Diabetes Burnout”

The conclusion about SMBG

• In well controlled T2D not on insulin achieving target HbA1c less than 7% (53mmol/mol) without glycaemic symptoms there does not appear to be evidence for SMBG

• In T2D not currently achieving glycaemic targets, symptomatic, risk of hypoglycaemia, sick day management, insulin and those in whom a therapy change is being considered SMBG has a role as long as patients are instructed in the interpretation

Glucose monitoring and diaries

• Ideally all patients on insulin are to monitor blood glucose levels at least twice daily - before breakfast [required] and at another time [preferably about 2 hours after a meal].

• Fingerprick glucose ideally with times & readings are to be recorded in glucose monitoring diary.

• Any symptomatic hypoglycaemic episodes are to be recorded in the diary.

• Patients are to be advised to bring the diary and meter in with them at every visit (option to upload data in clinic)

• Structured monitoring with feedback from the GP/PN/CDE is likely to be more effective

Case studies and questions

Tim

• 49 years old• T2D diagnosed at age 46• HbA1c 7.6% (60mmol/mol)• No complications on screening• Current diabetes medications:

– Sitagliptin metformin combination (Janumet) 50mg/1000mg bd

• Commenced on glargine – 10 units• Reached target fasting BSLs: 5-6mmol/L,

some post-prandial elevations

Tim continued

• Started exercise at lunch, getting hypo symptoms when getting back to the office

• Very hungry – adding chocolate milk to lunch

• Concerned about weight gain

How could you assist Tim to better manage this?

Karen

• 42 year old single

woman with three young

children• HbA1c 12%

(108mmol/mol) on

maximal oral therapy• Commenced on Lantus, achieved fasting levels

but high glucose excursions after evening meal• Inconsistent blood glucose monitoring• Commenced on Apidra

Karen continued

• Two episodes of hypoglycaemia following rapid acting insulin analogue – Fell asleep– Hypo whilst driving

What advice would you give Karen about hypoglycaemia management?

What are the options for the management of Karen’s diabetes?

What would you advise her about driving?

Hypoglycaemia management

https://www.diabetesaustralia.com.au/Understanding-Diabetes/What-is-Diabetes/Hypoglycaemia/#Treating Hypoglycaemia

AustRoads, Assessing Fitness to Drive for Commercial and Private Drivers, amended March 2013

AustRoads advice re Hypoglycaemia

AustRoads, Assessing Fitness to Drive for Commercial and Private Drivers, amended March 2013

5 to drive

Alberto

• 75 years old• HbA1c consistently

>10% (86mmol/mol)• Maximal oral therapy,

refused insulin for three years, now agrees to try

• BSLs 15 – 22+ mmol/L• Lantus increased from

10 to 22 units over the following week

Alberto continued

• One week later Alberto gets ‘hypo’ symptoms after a walk

• BSL is 8mmol/L• Does not want to titrate insulin further

What goals would you set for Alberto?

He was happy with the high blood glucose levels. Is insulin really necessary?

Contact Details

• Ms Louise Ginnivan - Diabetes Educator • 0499 599 084

• Dr Jo-Anne Manski-Nankervis: • 8344 3373 • jomn@unimelb.edu.au

© Copyright The University of Melbourne 2011