Insulin Prescribing Guidance - NHS Fife

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Insulin Prescribing
 Guidance
 Type 2 Diabetes
 This document aims to provide prescribing
 guidance to primary care practitioners with
 specialist knowledge and interest in diabetes
 management, on NHS Fife preferred insulin
 selection.

 NHS Fife Diabetes MCN Prescribing Subgroup
 Approved 6th April 2021

 Approved by NHS Fife MSDTC
 27th April 2021

NHS Fife acknowledges and agrees with the importance of
regular and timely review of policy/procedure statements and
aims to review policies within the timescales set out.

Reviewed policies/procedures will have a review date set
that is relevant to the content (advised by the author) but will
be no longer than 3 years.

If a policy/procedure is past its review date then the content
will remain extant until such time as the policy/procedure
review is complete and the new version published.

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 1 of 13   Review due: April 2023
Contents Page

 Introduction                                                                                               3

 Important Notes to Health Care Practitioner Initiating                                                     4
 and Managing Patients on Insulin

 Initiation of Insulin in Type 2 Diabetes                                                                   5

 Figure 1: Insulin Regimen Selection for Type 2 Diabetes                                                    6

 Figure 2: Once Daily Basal Insulin                                                                         7

 Figure 3: Twice Daily Fixed Mix Insulin                                                                    8

 Figur e 4: Basal Bolus                                                                                     9

 Figure 5: Intensification of Insulin Therapy                                                               10

 Appendix 1: Insulin Initiation Checklist                                                                   11

 References                                                                                                 13

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 2 of 13   Review due: April 2023
Introduction

 This document was produced to provide a guide for primary care practitioners in cost
 effective and safe prescribing of insulin therapy in Type 2 Diabetes. This Guidance is
 not prescriptive or exhaustive and should be used in conjunction with clinical
 assessment and decision making.

 This document was developed through consultation with key stakeholders to provide
 quality improvement namely safe, effective, and efficient and person centred. It is
 intended to be a living document and will continue to evolve as NHS Fife develops its
 services in response to new initiatives, changes in prescribing availability and research
 and through lessons learnt from its implementation.

 The purpose of this document is to ensure:

          Safe and effective insulin initiation through appropriate insulin regimen initiation
           and adjusting.
          Support Fife Formulary adherence.
          Cost effective selection of insulin therapies for initiation in Type 2 Diabetes.
          Support primary care practitioners’ confidence and management of insulin
           therapy in Type 2 Diabetes.

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 3 of 13   Review due: April 2023
Important Notes to Health Care Practitioner Initiating and Managing
 Patients on Insulin

          Primary Care Practitioners initiating and/or managing patients on insulin should be
           Independent Prescribers and have relevant training and/or experience in insulin initiation
           and management of insulin.
          Primary Care Practitioners should seek advice or refer patients to the Community
           Diabetes Specialist Nurse when they have reached their level of confidence and
           competence. Referral guidance and contact information can be accessed via
           Blink>Hub>Acute>Diabetes>Specialist Services>Community Diabetes Specialist Nurse
           Service https://app.joinblink.com/#/hub/ea71ee78-e29a-4849-b1ee-78e29a5849db
          All patients should be referred to the dietitian when initiated onto insulin and if changing
           insulin regimen.
          All patients commenced on insulin holding a driving licence must inform the DVLA.
           Please refer to the Driving and Vehicle Licensing Agency (DVLA) www.directgov.uk. and
           the Diabetes UK https://www.diabetes.org.uk/Guide-to-diabetes/Life-with-
           diabetes/Driving/
          First line insulin selection should be initiated within the chosen insulin regimen unless it is
           not clinically indicated. Please refer to NHS Fife Formulary
           http://www.fifeadtc.scot.nhs.uk/formulary/6-endocrine.aspx and Figure 1, page 6.
          Insulin manufacturers may change insulins and/or devices periodically. Current
           availability should be checked prior to prescribing. Metformin should be continued unless
           not tolerated or contraindicated. Sulphonylureas may be continued with basal insulin but
           should be discontinued with other multiple insulin dose regimens.
          The licensing of other agents with insulin is continually evolving and should be checked
           by the prescriber. Continuation (or initiation) of other oral anti-diabetic agents or GLP-1
           therapies with insulin should be referred to the Community Diabetes Specialist Nurse
           (CDSN) for consideration where practitioners feel this is out with their confidence and/or
           competence.
          Figures 2-5 provides guidance on insulin initiation and dose titration. However if a
           patient experiences an episode of hypoglycaemia that cannot be explained, or their blood
           glucose control is below their target range, the insulin impacting on that time of the day
           should be reduced by 2 units or 10%.
          Prescribing should be realistic and adjustment of treatment regime may be necessary in
           those at higher risk of adverse effects such as frail/elderly, residence in a nursing home,
           or chronic conditions (such as dementia, cancer, end-stage renal disease, severe chronic
           obstructive pulmonary disease or congestive heart failure).
          Remind patients to rotate injection sites within the same body region. Cutaneous
           amyloidosis at the injection site has been reported in patients using insulin and this may
           affect glycaemic control. For further advice, see MHRA Drug Safety Update September
           2020 https://www.gov.uk/drug-safety-update/insulins-all-types-risk-of-cutaneous-
           amyloidosis-at-injection-site

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 4 of 13   Review due: April 2023
Type 2 – Initiation of Insulin

Diagnosis of Type 2                  Decision to               Choice of                Initiation of            Management
Diabetes as per NHS                  initiate insulin          regimen                  insulin                  and review
Fife ‘Protocol for                   treatment
General Practice’

Stage

Diagnosis                 As per NHS Fife Diagnosis of Diabetes in Adults guidance
                          Blink>Hub>Acute>Diabetes>Guidelines, Pathways, Protocols & SOPs

 Decision to               Consider insulin initiation if patient failing to meet individual optimal glycaemic control despite
 initiate treatment        intensification of non-insulin therapies. Decision should be made on the following factors:
                                 Patient on maximum tolerated dose oral or GLP-1 therapies.
                                 Symptoms of hyperglycaemia.
                                 High HbA1c over three months.
                                 Raised HbA1c consistently above individualised patient target over a prolonged period
                                  e.g. six months or more. Refer to NHS Fife Protocol for General Practice for target
                                  setting. (Blink>Hub>Acute>Diabetes>Guidelines, Pathways, Protocols & SOPs)
                                 Lifestyle factors.

 Choice of                 In line with NHS Fife Formulary, and based on individual need and preference, with
 Regimen                   consideration of:
                                  Patient understanding
                                  Lifestyle
                                  Vision
                                  Manual dexterity
                                  Patient’s ability to perform blood glucose monitoring
                                  Patient support mechanisms
                              
 Initiation of             Discussion at initiation should include (see also Appendix 1: Insulin Initiation Checklist):
 insulin                         Education including hypoglycaemia
                                 Choice of insulin regimen – suitability, appropriateness, mode of action
                                 Dose titration
                                 Injection sites and technique
                                 Glucose monitoring and HbA1c
                                 Driving guidance
                           A dietetic consultation ideally before or close to the initiation of insulin is required to help
                           minimise weight gain and optimise insulin use by appropriate carbohydrate management

                            Review should be undertaken depending on clinical need, in consultation with nurse and
 Management and             dietitian.
 review
                                 First medical review should be undertaken within 12 weeks of initiation.
                                 Second medical review should be undertaken within a minimum of 6 months – or on a
                                  needs basis.
                            Structured review should include an assessment of:
                                 Clinical and lifestyle factors
                                 Symptoms- complications such as chronic complications, inter current illnesses,
                                  absence from work where applicable
                                 Advice on access to other services
                                 Unmet educational need, general wellbeing and emotional and psychological needs
                                 Agreed dietary modifications
                                 Patients should be encouraged to self manage, with support, and provision of the
                                  knowledge and skills to be an active partner in their care.
Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0     Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN         Where possible, patients
                                                Page: 5should
                                                        of 13 be Review
                                                                 seen by  theApril
                                                                        due:  same    person at each review.
                                                                                   2023
Figure 1: Insulin Regimen Selection for Type 2 Diabetes

                                                                           st
                         Once Daily (see figure 2)                        1 Line: Intermediate acting Insulin in the morning (e.g. Humulin I; Insulatard)
                                                                          1. Patient has good hypoglycaemia awareness and can interpret Blood Glucose (BG) results
                                                                          2. Patient can respond to hypoglycaemia and manage appropriately.
                    Consider once daily insulin in
                                                                          NB: Insulin can be given in the morning or twice daily to target rises in BG levels.
                    additional to oral anti-diabetic agents
                    or GLP-1 therapy to target fasting                     nd
                    hyperglycaemia or when individual                     2 line: Basal Analogue Insulins (e.g. Insulin Glargine (Abasaglar ; Lantus)
                    glycaemic target not met.                             1. Patients requiring insulin to be administered by community nursing team or timing of insulin
                                                                              administration a consideration (Note: Abasaglar is preferred formulary option but is not available in
                                                                              vials therefore Lantus vials should be prescribed).
                                                                          2. Patient is elderly or with reduced hypoglycaemia awareness.
                                                                          3. Patient is unable to BG monitor, interpret BG results and hypoglycaemia symptoms and respond
                    Pre-mixed
                      Pre-mixedInsulin                                        with appropriate hypoglycaemia management.
Patient failing                  Insulin (see figure 3)
                                                                          4. Prolonged duration of action desirable.
   to meet          (see
                    Consider pre-mixed insulin to target
  individual        fasting and post-prandial
   optimal          hyperglycaemia when insulin
                                                                           st
  glycaemic         intensification is required to meet a                 1 Line: Pre-mixed Human Insulin (e.g. Humulin M3)
    control         patient’s individual glycaemic target                 Patient must have a regular meal pattern and be able to plan their meals in advance to incorporate
                    and the advantage of fewer                            insulin which should be administered 20 minutes prior to meals.
    despite
                    injections is desirable.                              NB: Premixed insulin administered by community nursing staff should be Humulin M3 in vials.
intensification     NB: Patient must have a regular meal
of non-insulin      pattern.
  therapies.
                                                                           st
                                                                          1 line: Intermediate acting Insulin in the morning (e.g. Humulin I; Insulatard)
                         Basal Bolus (see figure 4)                       Patient should have good hypoglycaemia awareness.
                                                                          PLUS Soluble Human Insulin (e.g. Humulin S; Actrapid)
                                                                          Patient should have a regular meal pattern and be able to plan their meals in advance to incorporate
                    Consider a basal bolus regimen to                     insulin which should be administered 20 minutes prior to a meal.
                                                                            nd
                    target fasting and post-prandial                      2 line (consider if patient is elderly or has reduced hypoglycaemia awareness; or a prolonged
                    hyperglycaemia when insulin                           duration of action is required):
                    intensification is required to meet a                  Basal analogue Insulin Once daily (e.g. Insulin Glargine (Abasaglar))
                    patient’s individual glycaemic target                 This should be administered once or twice daily at approximately the same time each day.
                    and the advantage of flexible meal                    PLUS Soluble Human Insulin (e.g. Humulin S; Actrapid)
                    patterns and flexible dose adjusting                  Patient should have a regular meal pattern and be able to plan their meals in advance to incorporate
                    desirable. Patients should be able to                 insulin which should be administered 20 minutes prior to a meal.
                    self administer.

  If the above insulin regimens are unsuitable, please refer to your Community Diabetes Specialist Nurse.
  For other insulins not on the formulary, please refer to your Community Diabetes Specialist Nurse.
                          Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
                          NHS Fife Diabetes MCN                           Page: 6 of 13   Review due: April 2023
Figure 2: Once Daily Basal Insulin

            Starting Dose: Initiate 8-10units once daily or 0.2units/kg

             Intermediate acting insulin should be given in the morning or Basal analogue insulin
              given morning or night to target fasting blood glucose (FBG) levels.
             Continue oral antidiabetic agents: Metformin and Sulphonylureas.
             Discontinue other oral antidiabetic agents and/or GLP-1 therapy (if no proven benefit
              of recent glycaemic reduction).

            Insulin Adjustment: Monitor fasting blood glucose (FBG) daily (and at additional times
            as appropriate)

               Increase insulin dose by 2 units every 3 days or
               If FBG >10mmol/L increase insulin by 4 units every 3 days or
               If patient on >40units insulin daily, increase insulin by 4 units or 10% every 3 days.
               Continue titrating until FBG within target 4-7mmol/L or within individual target
                range.
               If hypoglycaemia occurs consider reducing the insulin by 2 units or 10%.

            Repeat HbA1c every 3 months until individual target achieved (see Figure 5)

            If FBG within target range but HbA1c >target range:
             Monitor blood glucose readings before breakfast, lunch, evening meal and supper.
             Consider changing insulin regimen.
             Consider additional oral antidiabetic agents or GLP-1 therapy to target insulin
                 resistance.
             Consider referral to Community Diabetes Specialist Nurse and/or dietitian.

            Insulin Regimen Change

                Consider changing to a twice daily insulin regimen to target prandial rises in blood
                 glucose levels (see figure 3 for titration advice). Starting dose would be current
                 total daily insulin dose divided by 2 minus 10%.
                Consider adding in meal time short acting insulin to target specific meals
                 once/twice/three times daily (see figure 4 for titration advice). Starting dose of 4
                 units with meal.

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 7 of 13   Review due: April 2023
Figure 3: Twice Daily Pre- Mixed Insulin

                   Starting Dose: Initiate 6-10units or 0.1units/kg twice daily
                   (Or see Insulin Regimen Change dose advice - Figure 2)

                       Premixed human insulin should be taken 20 minutes prior to
                        breakfast and evening meal.
                       Continue Metformin.
                       Continue GLP-1 therapy if proven benefit of glycaemic control.
                       Discontinue sulfonylureas and pioglitazone.
                       Monitor BG 2-4 times per day prior to breakfast, lunch, evening
                        meal and supper/bed.

                   Breakfast insulin                                                   Evening meal insulin

Increase by 2 units or 10% every three days                            Increase by 2 units or 10% every three days
until BG before lunch and evening meal is                              until BG before supper/bed and FBG is within
within 4-7mmol/L or individual target.                                 4-7mmol/L or individual target.

Repeat HBA1c every 3 months until individual target achieved (see Figure 5)

 If HBA1c remains above target:
  Continue to titrate insulin until BG within target 4-7mmol/L or individual target. If hypoglycaemia
     occurs, consider reducing the insulin controlling that time of the day by 2 units or 10%.
  Consider change in insulin regimen.
  Consider adding Gliptin or SGLT-2, GLP-1 therapy to target insulin resistance
     [Refer to Fife Formulary http://www.fifeadtc.scot.nhs.uk/formulary/6-endocrine.aspx].
  Consider refer to Community Diabetes Specialist Nurse and/or dietitian.

Insulin Regimen Change: Consider changing insulin regimen to three times daily mix or basal bolus as
follows (see Figure 4)

     If twice daily mixed insulin does not attain target of both corresponding pre-meal BG readings to 4-
      7mmols or individual target, consider switching to a three times daily mix.
      Refer to the Community Diabetes Specialist Nurse service for guidance.
     If twice daily mixed insulin does not permit target of both corresponding pre-meal BG readings to 4-
      7mmol/L or individual target or the patient finds the regimen too restrictive, consider switching to
      basal bolus insulin regimen. Take the total insulin dose, minus 10%. Divide by 50% for basal dose, and
      the other 50% divided into the three bolus doses (see Figure 4 for titration advice).

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 8 of 13   Review due: April 2023
Figure 4: Basal Bolus

                     Starting Dose: Initiate 8-10 units or 0.2units/kg basal insulin.
                                    Initiate 4 units bolus insulin with meals (or see change of insulin regimen dose advice Figure 3).

                              Basal Intermediate acting insulin should be given in the morning or basal long acting analogue given morning or
                               night to target Fasting Blood Glucose (FBG) Levels.
                              Soluble insulin should be given 20 minutes prior to meal/ rapid acting insulin should be given immediately before,
                               during or up to 15minutes after the meal.
                              Discontinue all oral antidiabetic agents and/or GLP-1 therapies if no proven benefit of glycaemic reduction except
                               Metformin.
                              Monitor blood glucose at least 4 times a day prior to breakfast, lunch, evening meal and supper/bed.

           Basal Insulin                                 Breakfast Bolus Insulin                              Lunch Bolus Insulin                               Evening-meal Bolus Insulin
   Increase insulin dose by 2                         Increase insulin dose by 2                       Increase insulin dose by 2                            Increase insulin dose by 2
    units every 3 days or                               units every 3 days or                             units every 3 days or                                  units every 3 days or
   Increase insulin by 4 units or                     Increase insulin by 4units or                    Increase insulin by 4units or                         Increase insulin by 4units or
    10% every 3 days if FBG                             10% if patient on >40units.                       10% if patient on >40units.                            10% if patient on >40units.
    >10mmol/L or if patient on                         Continue titrating until pre-                    Continue titrating until pre-                         Continue titrating until pre-
    >40units basal insulin.                             lunch BG within target                            evening meal BG within                                 supper/bed BG within target
   Continue titrating until FBG                        4-7mmol/L or within                               target 4-7mmols or within                              5-8mmols or within
    within target 4-7mmol/L or                          individual target range.                          individual target range.                               individual target range.
    within individual target range.


                                                                               Ongoing Care (See Figure 5)

                    Continue to titrate insulin and repeat HbA1c every 3 months until patient has reached individual BG and HBA1c target.
                    If hypoglycaemia occurs, consider reducing the insulin controlling that time of the day by 2units or 10%.
                    If patient failing to achieve individual targets, consider adding in Gliptin, SGLT-2 or GLP-1 therapy, to target HbA1c and
                     reduce insulin requirement [see Fife Formulary http://www.fifeadtc.scot.nhs.uk/formulary/6-endocrine.aspx].
                    If patient failing to achieve individual targets, consider referral to the Community Diabetes Specialist Nurse and/or dietitian.

                               Insulin Prescribing Guidance: Type 2 Diabetes      Version: 04.0    Approved by Diabetes MCN Prescribing Group: 6th April 2021
                               NHS Fife Diabetes MCN                              Page: 9 of 13   Review due: April 2023
Figure 5: Intensification of Insulin Therapy

     Target                      Review                     Discuss                    Implement                  Review
     HbA1c                       current                    options for                change
     Criteria                    management                 change                                              Objectives
                                                                                                                achieved?

                                                                                                            NO          YES

     Stage

      Criteria                                  For target HbA1c:
                                                        Target HbA1c not achieved.
                                                        Target HbA1c but disabling hypoglycaemia.
                                                        Lifestyle.
                                                Patient agreement to intensify their insulin management to achieve
                                                individual target.

       Review and current                        Review current factors to determine the most appropriate way that
       management                                treatment management can be intensified. This review should
                                                 incorporate as a minimum the following:
                                                         Informed decision making.
                                                         Patient’s priorities.
                                                         Lifestyle factors.
                                                         Injection technique.
                                                         Blood glucose profile.
                                                         Symptoms of acute complications such as hypoglycaemia,
                                                          chronic complications, inter current illnesses, absence from
                                                          work where applicable.
                                                         Current oral or insulin therapy and regimen.
                                                         Psychological issues.
                                                         Dietetic assessment/review and further intervention e.g. for
                                                          appropriate carbohydrate management.

      Discuss options for change                        Consider referral to dietitian or Structured Patient Education or
                                                         Community Diabetes Specialist Nurse Service.
                                                        Consider intensifying the insulin regimen to a pre-mixed or
                                                         multiple premixed injection regimen with meals or basal bolus
                                                         regimen.
                                                        Consider introduction of additional oral agents or GLP-1
                                                         therapy.

      Implement change                                  Provide advice and support through agreed changes made to
                                                         treatment.
                                                        Review.
                                                        Establish and evaluate from a clinical and patient perspective
                                                         whether changes have achieved desired health outcomes.
                                                        Patients should be encouraged to self manage, with support,
                                                         and provision of the knowledge and skills to be an active partner
                                                         in their care.
                                                        Implement further treatment changes where and as appropriate.

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0     Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 10 of 13   Review due: April 2023
Appendix 1 – Insulin Initiation Checklist
                                                  INSULIN CHECKLIST
Patient Details                                        Medication changes

                                                       STOP –

                                                       START –

                                                            Date/sign                   Date/sign                   Date/sign
Blood Glucose Monitoring
 - Meter Type
 - Testing times
Injecting
 - Storage
 - Preparation
 - Technique
 - Sites and rotation
 - Lypohypertrophy
 - Sharps disposal
Adjusting Insulin
 - Self management/Titration sheet
Driving
 - DVLA
 - Signed information letter and leaflets
 - Insurance
Hypoglycaemia
     mild/moderate/severe
     Nocturnal Hypos
     Treatment and prevention
Hyperglycaemia
Sick Day Rules
Complication Prevention
       Eye screening
       Foot screening
       Biochemistry/AC ratio
       BP
       Weight/BMI
       My Diabetes My Way referral
Lifestyle
       Exercise
       Travel
       Sex
       Alcohol
       Diet
       Dietitan referral
Additional comments:
(Continue overleaf if required)

  Insulin Prescribing Guidance: Type 2 Diabetes    Version: 04.0     Approved by Diabetes MCN Prescribing Group: 6th April 2021
  NHS Fife Diabetes MCN                            Page: 11 of 13   Review due: April 2023
Appendix 1 – Insulin Initiation Checklist (continued)

 Written Information Provided.
       Driving/DVLA guidance

       Hypoglycaemia

       Travel Advice

       Travel Letter

       Diabetes and illness/sick day rule card

       Beating the Blues

       Insulin card/Passport

       Injection technique

       Insulin starter pack/ information

       Blood glucose diary

       Titration Advice

       My Diabetes My Way card

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0     Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 12 of 13   Review due: April 2023
References
 Gale (2012) Newer Insulins in Type 2 Diabetes BMJ 345:e4611

 Indian Health Service (2011) Standards of Care and Clinical Practice
 Recommendations: Type 2 Diabetes; Type 2 Diabetes and Insulin Algorithm.
 http://www.ihs.gov/MedicalPrograms/Diabetes/HomeDocs/Tools/Algorithms/DM_algorith
 m_Insulin_508c.pdf

 Kentucky Diabetes Network (2006) Algorithms for Glycaemic management of Type 2
 Diabetes http://chfs.ky.gov/NR/rdonlyres/C3DF067A-CB05-4C16-8C71-
 5DDAEA586421/0/AlgorithmTools62507.pdf

 Texas Diabetes Council (2010) Insulin Algorithm for Type 2 Diabetes Mellitus in Adults
 and Children www.tdctoolkit.org/algorithms_and_guidelines.asp

 Scottish Government Polypharmacy Model of Care Group (2018). Polypharmacy
 Guidance, Realistic Prescribing 3rd Edition. Scottish Government.
 www.therapeutics.scot.nhs.uk/Polypharmacy-Guidance-2018.pdf

Insulin Prescribing Guidance: Type 2 Diabetes   Version: 04.0     Approved by Diabetes MCN Prescribing Group: 6th April 2021
NHS Fife Diabetes MCN                           Page: 13 of 13   Review due: April 2023
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