Enhanced General Practice Management of Diabetes Starting

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Enhanced General Practice Management of
Diabetes
Starting insulin in general practice
Jo-Anne Manski-Nankervis
Louise Ginnivan
General Practice and Primary Health Care Academic Centre
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
2
Stratton et al (2000), BMJ 321:405-412
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)
≤ 6%
(42mmol/mol)
Pregnancy or planning a
pregnancy
DM of longer duration (> 10-
Any form of therapy
≤ 7%
(53mmol/mol)
Recurrent severe hypo or
Any form of therapy
≤ 8%
(64mmol/mol)
major comorbidities likely to limit life
Any form of therapy
Symptomatic
therapy
20 years) or has CV disease
hypo unawareness
Patients with
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.
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
PP BGL is the first
abnormality
IR not
increasing
Relative insulin
deficiency
starts
Eventual
absolute insulin
deficiency
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
Clinical inertia in response to inadequate glycaemic control:
Do specialists differ from primary care physicians?
p=0.009
p=0.7
p=0.2
p<0.0001
Should we be commencing insulin in general
practice?
Endocrinologist 1:2000
• 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)
1 Davies
Practice nurse
1:125
CDE-RN
1:630
GP 1:47
et al (2007) Diabetes Obesity & Metabolism 9(5):706-13.
et al. (2013) Family Practice 30(3):290-3.
2 Samann
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

Belief that patient wouldn’t comply with treatment

Fear of addiction

Fear of hypoglycaemia in a specific patient

Belief that insulin makes patient fat

Belief that patient couldn’t cope with pain involved in

Fear of hypoglycaemia

Belief that insulin would not help

Patient too old or inadequate level of education

Pain associated with insulin injection

No experience with treatment

Other fears regarding injection of insulin

Not wanting to give to obese patients because 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

Belief that insulin initiation is complex

Non-compliance with medical appointments

Lack of motivation to improve clinical practice

Non-compliance with medications

Belief that insulin would impair patient quality of life

Patient co-morbidities
insulin injection
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
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
Ambivalence
•
Wanting and not wanting to change, being ‘stuck.’
•
Normal, common, powerful
“Are we Dancing or Wrestling?”
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
Importance-confidence-readiness
10
9
Readiness
8
7
Importance
6
“Do I want to
change?”
5
4
3
2
1
1
2
3
4
5
6
7
Confidence
“Can I change?”
8
9
10
Principles of motivational interviewing
Express Empathy
–
•
Develop Discrepancy
–
–
•
Importance/confidence ruler
Change talk
Roll with resistance
–
–
–
•
Ambivalence is normal.
Understand the patients
perspective
Reframe patient concerns
positively,
Avoid confrontation
Emphasize personal choice and
control
Support Self-Efficacy
–
Belief in the ability to change is an
important motivator
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
2
4
6
8
10 12
14
16
18
20
22
24hours
Rapid acting
analogue
Basal analogue
(insulin glargine)
2
2
4
4
6
6
8
8
10 12
10 12
14
14
16
16
18 20
18 20
22
22
24 hours
24hours
30% rapid-acting &
70% intermediateacting analogue
insulin
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
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
Tasks: GP
assesses need
for insulin and
documents plan
to use protocol.
PN gives first
Lantus dose
PN
Baseline
visit 2
(next day)
Tasks: PN
watches patient
give their own
dose, check
technique etc
BASAL
TITRATION TOOL
Titration
calls or F-F
with PN
PN
Reminder
call
Tasks: PN
works with
patient to uptitrate, liaison
with GP and
DNE/Endo as
needed
Tasks: PN
reminds
patient re
next
weeks visit
GP and PN
Week 4
visit and
monthly
thereafter
FBGLs 4 - 7.0
consistently
Decision made
to consider
Rapid acting
insulin
analogue
Tasks: GP
and PN
clinical
review
Tasks: PN and
GP liaise,
review and
decision to
start Rapid
acting insulin
analogue
Timeline
0
0+1
day
Target Fasting
glucose
levels: 47mmol/L
Week
s 1-3
3
4, 8, ...
X
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
Tasks: GP
assesses need
for insulin and
documents plan
to use protocol.
PN gives first
Lantus dose
PN
Baseline
visit 2
(next day)
Tasks: PN
watches patient
give their own
dose, check
technique etc
BASAL
TITRATION TOOL
Titration
calls or F-F
with PN
PN
Reminder
call
Tasks: PN
works with
patient to uptitrate, liaison
with GP and
DNE/Endo as
needed
Tasks: PN
reminds
patient re
next
weeks visit
GP and PN
Week 4
visit and
monthly
thereafter
FBGLs 4 - 7.0
consistently
Decision made
to consider
Rapid acting
insulin
analogue
Tasks: GP
and PN
clinical
review
Tasks: PN and
GP liaise,
review and
decision to
start Rapid
acting insulin
analogue
Timeline
0
0+1
day
Target Fasting
glucose
levels: 47mmol/L
Week
s 1-3
3
4, 8, ...
X
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
PPBGL
<7.8
<10
<7.8
<8.0
4.5 - 10.0
2 hours
postprandial
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?
What’s involved?: Starting Rapid acting insulin analogue
(Rapid acting insulin analogue: Apidra/Novorapid/Humalog)
addressing 2hr post-prandial glucose levels
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 analogue
See patient and
do 3 DAY PROFILE
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
Tasks: PN
works with
patient to uptitrate, liaison
with GP and
DNE/Endo as
needed
Tasks: PN
reminds
patient re
next
weeks visit
GP and PN
Week 4
visit and
monthly
thereafter
PPBGLs
4.5 - 10.0
consistently
Tasks: GP
and PN
clinical
review
Tasks:
Ongoing
clinical
monitoring
Timeline
X
X+1
Weeks X + 1-3
Target PostPrandial Glucose
levels: 4.510mmol/L
X+3
X+4, 8, ...
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.
2.
3.
4.
5.
6.
7.
8.
9.
10.
The meter makes me feel bad about myself
Monitoring seems pointless (because there is nothing I can really do
about my blood glucose results anyway).
Checking blood glucose reminds me that I have diabetes – 24/7
The meter seems to control my life, telling me what I can and cannot do.
Monitoring serves as an opportunity for friends and family to bother me
None of the health care providers ever do anything with the results
anyway.
Checking blood glucose sometimes hurts.
Monitoring can be inconvenient.
Monitoring can be expensive.
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
5 to
drive
AustRoads, Assessing Fitness to Drive for Commercial and Private Drivers, amended March 2013
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
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