WHO Guidelines for
Management of Diabetes in
Low Resource Settings
Dr. Alok Shetty K
Senior Resident
Department of Medicine
24th November, 2018
St. John’s Medical College & Hospital
WHO vs ADA-EASD
Revisiting the previous case>>>>
• Patient 62 year old, smoker, admitted with NSTEMI,
• HbA1c – 10.6(newly detected), with HFrEF and eGFR – 58%.
• Patient planned for discharge. What medications?
• Combination – Metformin + GLP-1RA /Basal Insulin
• Can consider SGLT2, DPP4
THEORY
REALITY>>>>>>>>
• Husband and wife stay alone. Separated from children
• Only income from a rented house
• One son is drunkard who takes away the little income that they earn
• Both husband and wife illiterate
• Husband has bilateral cataract with probable retinopathy- Poor vision
Money Matters!!!
>>Total annual expenditure for a diabetic patient was on average-
~ Rs.10,000 in Urban areas
~ Rs.6260 in Rural areas
>>India:85%-95% of health care costs borne by individuals and families.
>>Multiple factors are involved-Direct + Indirect Costs
Economic Burden ofDiabetes-APIUpdate-2013
• Some countries- Documented expenditures on insulin analogues
surpassed the total budget for insulin,
leading to shortages of insulin for part of the diabetic population that
needed it.*
• Study of 35 developing countries found that people with diabetes had a
substantially higher risk of incurring catastrophic personal medical
expenditure.**
*El Naggar N, Kalra S. Switching from biphasic human insulin to premix insulin analogs: a review of the evidence regarding quality of life and
adherence to medication in type 2 diabetes mellitus. Advances in Therapy. 2017;33(12):2091–109.
**Davies MJ et al Real-world factors affecting adherence to insulin therapy in patients with type 1 or type 2 diabetes mellitus: a systematic review.
Diabetic Medicine. 2013;30(5):512–24. s than their peers without diabetes.
Drug Cost per tablet
GLICLAZIDE Rs.3.95
GLIMEPIRIDE Rs. 3.77
GLIPIZIDE Rs. 1.61
VILDAGLIPTIN Rs. 26.52
TENELIGLIPTIN Rs. 10.12
CANAGLIFLOZIN Rs. 54.90
Ann Intern Med. 2018;169:394-7.
AIM of the guidelines---
• Provide public health guidance on pharmacological agents for
managing hyperglycaemia in type 1 and type 2 diabetes for use in
primary health-care in low-resource settings.
To Update WHO Package of Essential NCD Interventions (WHO PEN)-2013 –
--Considering newer evidence and medications for Diabetes
Introducing simple
Integrating Task sharing clinical monitoring
services at the
primary care
level
Providing care and
Simplified drug drugs free of charge
formularies
OBJECTIVE
• To consider the use of DPP-4 inhibitors, SGLT-2 inhibitors, and TZDs
as 2nd line and 3rd line treatment after metformin & sulfonylurea for
controlling hyperglycaemia in type 2 diabetes in non-pregnant adults,
including whether these oral agents are preferable to insulin.
• To provide guidance regarding the use of insulin analogues for type 1
and type 2 diabetes.
TARGET POPULATION
of the guidelines Policy
makers
National Guideline
Diabetes Makers in
low
Programme income
Managers countries
Relief
NGOs
Workers
Recommendation1
Recommendation2
Second line medications
Third Line Medications
Recommendation 3
Recommendation 4 Recommendation 5
When and which insulin to use
RECOMMENDATION 1
• Give a sulfonylurea to patients with
type 2 diabetes who do not achieve glycemic control with
metformin alone or who have contraindications to metformin
Strong recommendation
Moderate-quality evidence
Remarks::::
• Glibenclamide- Should be avoided in patients aged 60 years and older.
• SUs with a better safety record for hypoglycaemia (e.g. gliclazide)
- Preferred in patients for whom hypoglycaemia is a concern.
• Individualized approach is encouraged in setting the patient’s target
level for glycaemic control.
--co-morbidities –adverse effects -life expectancy
GUIDELINE GROUP thoughts::::
• With respect to new drugs more evidence is needed to determine whether this
is a class effect and whether there is a cardio-protective effect in the general
population of people with type 2 diabetes.
• Lack of RCTs on how each new drug class compares with all the others
(particularly new agents vs. old ones) and concluded that the evidence
reviewed did not convincingly show the superiority or inferiority of any one
class.
• New OHAs are currently substantially more expensive compared to
sulfonylureas, & the modest clinical benefit does not sufficiently
outweigh the current price difference in the context of a public health
approach.
• Industry-funded cost-effectiveness studies tended to report that new
treatments were cost-effective while the only independent study
favoured sulfonylurea.
RECOMMENDATION 2
• Introduce human insulin treatment to patients
with type 2 diabetes who do not achieve glycemic control
with metformin and/or a sulfonylurea
Strong recommendation
Very-low-quality evidence
RECOMMENDATION 3
• If insulin is unsuitable*, a dipeptidyl peptidase-4 (DPP-4) inhibitor,
a sodium–glucose cotransporter-2 (SGLT-2) inhibitor, or a
thiazolidinedione (TZD) may be added
Weak recommendation
*(e.g. persons who live alone and are dependent on others to
Very-low-quality evidence inject them with insulin).
GUIDELINE GROUP thoughts::::
• Patient preference for newer oral agents was not deemed a
sufficiently strong reason to recommend them in the context of a
public health approach because the price of newer oral medicines is
currently higher than that of human insulin.
• Insulin treatment has further associated resource implications such
as needles and blood glucose self-monitoring.
RECOMMENDATION 4
Use human insulin to manage blood glucose
in adults with type 1 diabetes and in adults with type 2
diabetes for whom insulin is indicated
Strong recommendation
Low-quality evidence
The recommendation is strong because evidence of better
effectiveness of insulin analogues is lacking and human insulin
has a better resource-use profile.
RECOMMENDATION 5
• Consider long-acting insulin analogues to
manage blood glucose in adults with type 1 or type 2 diabetes
who have frequent severe hypoglycemia with human insulin
Weak recommendation,
Moderate-quality evidence for severe hypoglycemia
weak recommendation reflecting the lack of, or very low-quality evidence for, any
of the long-term outcomes such as chronic diabetes complications and mortality,
and the considerable higher costs for long-acting insulin analogues compared to
intermediate-acting human insulin.
GUIDELINE GROUP thoughts::::
• In the absence of universal health coverage, insulin analogues are far
more expensive for patients paying out-of-pocket .
• Although short-acting insulin analogues statistically significantly
reduced HbA1c compared to short-acting human insulin,
the Guideline Group did not consider this to be a clinically
meaningful reduction according to criteria widely used in clinical
guidelines and recommendations of medicines licensing bodies.
SUMMARY
• In low resource settings cost is a major concern while deciding
treatment regimens in patients.
• On a community level, cost –benefit outcomes need to be strongly
considered while preparing local guidelines.
THANK YOU
