AACE Policy Statement: Access to Diabetes Medication and Technology
June 2020

Authors: Rebecca J Morey, MD; Adegbenga Bolanle Ademolu, MBBS; Joseph A Aloi, MD; Pavan Chava, DO; Armand Krikorian, MD; Ralph Schmeltz, MD; Shehzad Topiwala, MD; Janet B McGill, MD


Diabetes mellitus is a common, chronic disease affecting over 30 million Americans.[1] Approximately 5 – 10% of Americans with diabetes have type 1 diabetes mellitus (T1DM), which may develop anytime from early childhood through adulthood and require adequate insulin therapy to survive. About 90% of Americans with diabetes have type 2 diabetes mellitus (T2DM), a disease characterized by insulin resistance and ultimately inadequate insulin production. While diet and exercise are key components of treatment, medical intervention is crucial for tens of millions of patients with both T1DM and T2DM. Up to 30% of patients with T2DM or other forms of diabetes (diabetes from pancreatic disease, gestational diabetes, monogenic forms of diabetes) are insulin deficient and require insulin for control of glucose or to sustain life. In addition, there are 84 million Americans with prediabetes who are at increased risk of progression to overt T2DM.[2]


Blindness: Diabetes is the leading cause of new blindness in adults. Approximately 4.2 million American adults have eye complications from diabetes. Of these, 655,000 have vision threatening diabetic eye disease. Over $500 million is spent annually on diabetes-related blindness. Effective treatment and prevention exist, but once blind the condition is irreversible.[3]

Kidney Disease: From 2011-2014, 24% of Americans with diagnosed diabetes had advanced stage chronic kidney disease (CKD), compared with 5% of people without diabetes. [4] In 2014, 44% of the 120,000 Americans who began dialysis or had a kidney transplant for end stage renal disease (ESRD) required treatment as a complication of their diabetes.[5] Currently over 662,000 Americans are living on chronic dialysis or have had a kidney transplant.[6] Chronic kidney disease and kidney failure are extremely expensive. In 2017 Medicare spent $84 billion dollars related to chronic kidney disease and an additional $36 billion on end stage renal disease.[7]

Neuropathy and Amputation: Elevated blood sugar levels can cause a form of nerve damage called neuropathy. Over time, severe neuropathy can lead to complications such as limb amputation. Diabetes is the most common cause of lower-limb amputations in the United States.[8] Approximately 108,000 Americans are hospitalized for a lower-extremity amputation each year.[9]

Diabetic Ketoacidosis:  Diabetic ketoacidosis (DKA) is a preventable, life-threatening condition that occurs in patients with both T1DM and T2DM. DKA almost always requires hospitalization and high-level care in an intensive care unit. Approximately 6% of patients with type 1 diabetes will be hospitalized each year with DKA, and approximately 0.4-1% will die during that hospitalization. These tend to be younger Americans, most less than 45 years old.[10]

Hypoglycemia: Hypoglycemia, or low blood sugar, is a potentially life-threatening condition that can result in neurologic dysfunction, seizure, coma or death. All people taking insulin are at risk of severe hypoglycemia, and estimates report that between 4% and 10% of patients with type 1 diabetes die from hypoglycemia.[11] The cost to Medicare for emergency medical services (EMS) and transportation averaged $680 per hypoglycemic event. Once in the emergency department, hypoglycemia-related treatment averaged $1,293 per event. Hypoglycemia is a common, expensive, and life-threatening complication of diabetes.

Diabetes in Pregnancy: Diabetes mellitus in pregnancy, especially when poorly controlled, confers significant risks to the mother and baby. These risks include fetal death, congenital malformation, and maternal preeclampsia.[12] Catastrophic and preventable malformations include major defects of the heart, brain, kidneys, spine, and intestines. Birth defects also increase risk of requiring extended stays in the neonatal intensive care unit. The risk of significant congenital malformations is highest with uncontrolled diabetes in the first trimester, sometimes before a woman even knows that she is pregnant. Nearly half of all pregnancies in the United States are unplanned.[13] Poor pre-conception diabetes control is associated with a 5-fold increased risk of cardiovascular malformations and accounts for 50% of all infant deaths born to these mothers.[14]

Women who develop diabetes of pregnancy (gestational diabetes) have increased risk of complications in pregnancy including having too large or too small babies or developing preeclampsia. They are also at higher risk of developing T2DM later in life. Good glycemic control before and during pregnancy improves outcomes for both the mother and baby and prevents potentially catastrophic outcomes.

Heart Attack, Stroke and Death: Diabetes substantially increases the risk of Major Adverse Cardiovascular Events (MACE) such as stroke, heart attack, or death. Compared to adults without diabetes, adults with diabetes are 2 to 4 times more likely to die from heart disease. At least 68% of people with diabetes mellitus over the age of 65 die from heart disease and 16% die from stroke.[15]


Multiple large, high-quality studies have conclusively shown that improved diabetes control reduces chronic complications from diabetes. It is widely accepted and evidence-based that good diabetes control can delay the onset of diabetic eye disease, kidney disease, and nerve damage.[16] [17] [18]

Reduced Blindness: The landmark Diabetes Control and Complications Trial (DCCT) followed patients with type 1 diabetes and showed that good blood sugar control led to a 76% reduced risk of developing diabetic eye disease. Of patients with diabetic eye disease, intensive therapy reduced progression by 54% and reduced the risk of severe disease by 47%.[i] The UKPDS followed patients with type 2 diabetes and found that modest improvements in hemoglobin A1C (1.1% between control and intervention groups) reduced the relative risk of needing treatment for diabetic eye disease by .29 and blindness in one eye by 0.16.[19] Blindness from diabetes is preventable.

Reduced Kidney Disease: The DCCT showed that intensive blood sugar control reduced early kidney disease (microalbuminuria) by 39%.[20] Newer medication agents such as SGLT2 Inhibitors are now FDA approved for reducing risk of developing end stage renal disease (ESRD).[21]

Reduced Neuropathy (Nerve Damage) and Amputation: The DCCT showed a 60% reduction in neuropathy with intensive treatment of diabetes.[22] Good glycemic control can significantly decrease the development and progression of diabetic neuropathy.

Reduced DKA: Access to insulin for patients with type 1 diabetes and good glycemic control reduce risk of diabetic ketoacidosis (DKA).[23] Patients with an A1C above 9% have an odds ratio of 8.7 of developing DKA compared to those with A1Cs less than 7.5%.

Reduced Hypoglycemia: Risk of hypoglycemia (low blood sugar) is substantially reduced or eliminated with newer classes of medications for T2DM such as GLP1 Receptor Agonists and SGLT2 Inhibitors. For patients who are on insulin, using modern technology including Continuous Glucose Monitors (CGMs) can substantially reduce the rates of hypoglycemia.[24] CGMs are small, external devices that sit on the skin and monitor blood sugar many times each hour. They are becoming standard of care in the treatment of diabetes. Glucagon is an emergency treatment for life-threatening low blood sugar. New formulations of glucagon can help caregivers provide emergency relief to hypoglycemic Americans more quickly and effectively than ever before.[25] Severe hypoglycemia can be fatal, but the risk can be dramatically decreased with appropriate medication and technology.

Reduced Pregnancy Complications: The risk of major congenital abnormalities is proportional to how hyperglycemic the mother is during pregnancy. Improved glycemic control reduces risk of pregnancy complications. In addition, pre-pregnancy glycemic control is associated with improved maternal and fetal health outcomes.[26] This means fewer babies with catastrophic heart, brain, and other organ dysfunction.

Reduced Strokes, Heart Attacks, Death: It is well-established through multiple large, multi-center, randomized control trials that effective treatment of type 2 diabetes with modern medications can reduce the risk of heart attacks, strokes, and cardiovascular death.[27] [28] [29] GLP1 Receptor Agonists have been shown to reduce the rate of nonfatal strokes by 39% over approximately two years.[ii] Medications have been shown to reduce risk of initial stroke in SUSTAIN-6 and PROactiv studies and protect against recurrent stroke in the IRIS trial. The data is so compelling that GLP1 Receptor Agonist and SGLT2 Inhibitor therapy has become standard of care, especially for patients at high risk for cardiovascular disease.[30]


Access to Care Improves Outcomes: The Special Diabetes Program for Indians (SDPI) was started in 1997 to treat and prevent diabetes among Indian Health Service, Tribal, and Urban Indian health programs in the United States.[31] This sustained intervention has shown a 54% reduction in end stage renal disease (ESRD) rates between 1996 and 2013.  Analysis by the Assistant Secretary for Planning and Evaluation estimates a Medicare savings of between $436 to $530 million over a ten-year period due to the reduction in ESRD.

The SPDI has also achieved a 50% reduction in diabetic eye disease. Despite an aging population, diabetes rates in adults in this population have not increased since 2011. Consistent, effective care reduces complications from diabetes including blindness and kidney dialysis.

Lack of Health Insurance and Preventive Care is a Problem:

In 2018, 27.9 million nonelderly individuals were uninsured in the United States. While significantly improved from the 46.5 million uninsured Americans in 2010 before the Affordable Care Act (ACA) was enacted, too many Americans still do not have access to affordable healthcare.[32] This is especially critical for patients with chronic diseases like diabetes mellitus where early detection and treatment reduces long-term complications. Approximately 1 out of 4 Americans with diabetes mellitus does not know they have the condition.[33] Nearly 1 in 2 patients with severely reduced kidney function not yet on dialysis are not aware of having severe kidney disease.[34] If these patients knew they had diabetes or severe kidney disease they could be treated appropriately to reduce the risk of complications of these diseases. Access to care through the ACA improved screening rates for diabetes and is an important part of healthcare delivery in the United States.[35]

America’s youth, particularly those from low resource settings, need a backstop like the Children’s Health Insurance Program (CHIP) to close the insurance gap and provide coverage for patients with chronic conditions such as Type 1 DM.  American youth from families with private health insurance may stay on  family plans until age 26. CHIP coverage should be offered to cover these vulnerable young adults, in a manner consistent with the same rules that apply to private plans.

High Costs of Medications and Healthcare Is a Problem:

In the 2018 National Health Interview Survey done by the Centers for Disease Control and Prevention (CDC), 45% of respondents cited insurance cost as the cause for being uninsured.[36] Even for those with insurance, the cost to patients of life-sustaining medications like insulin nearly doubled from 2002 to 2013.[37] In 2013 the average cost to patients for diabetes medication per year was over $500.[38]

Studies have shown that reducing cost of medications can improve adherence, improve glycemic control, and decrease emergency department visits. Similarly, increasing patient copayments for diabetes medications decreased drug utilization by 23%.[39]

Access to Diabetes Technology Improve Glycemic Control and Reduces Hypoglycemia

Current diabetes technology includes insulin infusion pumps systems, continuous glucose monitors (CGM) and hybrid closed-loop systems that can integrate the glucose signal from CGM to insulin infusion delivered by insulin pumps.  These continuously evolving technologies have been shown to improve outcomes through improved glycemic control and reduced hypoglycemia. 

Over the past 20 years technology has become more reliable, compact, and economical. While historically patients had to prick their finger and use a hand-held meter to find out their blood sugar at one particular point in time, CGMs, small, external devices that sit on the skin and monitor blood sugar many times each hour, can give life-saving information about blood sugars over previous hours or days. Some CGMs can alarm and warn patients of dangerously high or low blood sugars. Multiple studies have demonstrated improved glycemic control, usually with reduction in hypoglycemia, in patients using CGM.[40]

Similarly, an insulin pump provides continuous delivery of short acting insulin all day long. The insulin pump substitutes long acting insulin. A pump also replaces the need for multiple daily injections with a continuous insulin infusion.

The technology is rapidly advancing, with increasing closed-loop communication between CGMs and insulin pumps and machine learning algorithms that improve outcomes and reduce adverse events. These technologies also interact with smart devices and applications to enhance usability for patients, including those that are visually impaired.


  1. Every American should have access to basic healthcare including screening for chronic diseases and treatment for their illnesses, access to treatment for mental illness, and resources to foster a healthy lifestyle including access to healthy food.
  2. Every patient with diabetes should have access to: affordable diabetes medication – including insulin - and technologies; diabetes education; and behavioral health services to mitigate comorbidities that complicate diabetes management.
  3. Discrimination against patients with diabetes should never be tolerated
  4. Adequate funding of diabetes research will allow researchers to make breakthroughs that can turn the tide on this insidious disease.
  5. Diabetes technology can be an effective tool to improve the quality of life, blood glucose control, and avoidance of hypoglycemia in persons with diabetes. 


  1. There should be increased access to medical care.  This may include:
    • Prohibition of insurance discrimination against preexisting conditions;
    • Coverage expansion of CHIP and Medicaid on a routine basis
    • Coverage of contraception for patients with diabetes;
    • Increase funding for both components of the Special Diabetes Program.
  2. Cost of medicine should not be a barrier for patients to receive medical treatment for diabetes. To ease the burden decision makers should:
    • Reduce the out of pocket costs for patients to make medications more affordable and prevent a barrier to adherence.
    • Allow the secretary of HHS to negotiate drug prices for Medicare Part D program to allow for cost savings to the patient.
    • Ensure rebates and discounts are used to decrease out of pocket expenses for the patient.
    • Patients with diabetes should have access to vaccinations against infections that place them at risk including influenza, pneumococcus, and COVD-19 if and when the latter becomes available.  
  3. Encourage pricing transparency among entities in the entire pharmaceutical supply-chain, including: manufacturers, wholesalers, pharmacy benefits managers (PBM), health plans, and pharmacies.
  4. Protect continuity of patient care by:
    • Prohibiting mid-year formulary changes such as drug removal or tier-increases except in the case of FDA safety alerts.
    • Prohibiting step therapy in patients who change insurance for medications.
    • Allowing for transparent formularies for patients as they are choosing insurance plans
  5. Reduce patient burden to step therapy:
    • Health plans should be discouraged from requiring step therapy when physicians and health care providers are following scientific guidelines as it can be an impediment timely and appropriate care.
    • Step therapy protocol should have provisions for automatic exceptions including: low risk of success, contraindication, patient stability or medical necessity.
    • There should be a well-defined and expedited process to get a step therapy appeal when deemed necessary by the patients physician or health care provider to allow for timely and appropriate care
  6. Encourage development and approval of safe and effective follow-on or biosimilar insulin products.
  7. Patients with diabetes should have access to vaccinations against infections that place them at risk including influenza, pneumococcus, and COVID-19 if and when the latter becomes available.
  8. Payer imposed coverage requirements for diabetes technology, such as outdated diagnostic criteria, lag behind a constantly evolving technological landscape and should be revised to reflect evidence based clinical practice guidelines.
  9. Diabetes technology should be interoperable among device types with a common user interface between CGM, insulin pumps, and glucose administration devices should be developed. The easier these products are to use, the more the technology can be harnessed by patients, primary care providers, and subspecialists to improve patient outcomes.

[1] Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2017.

[2] https://www.cdc.gov/diabetes/basics/prediabetes.html

[3] https://www.cdc.gov/visionhealth/pdf/factsheet.pdf

[4] National Health and Nutrition Examination Survey 2011-2014. https://nccd.cdc.gov/CKD/detail.aspx?Qnum=Q702#refreshPosition

[5] Rios Burrows, Nilka. “Incidence of End-Stage Renal Disease Attributed to Diabetes Among Persons with Diagnosed Diabetes - United States and Puerto Rico, 2000–2014.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 2 Nov. 2017, www.cdc.gov/mmwr/volumes/66/wr/mm6643a2.htm.

[6] https://www.cdc.gov/kidneydisease/pdf/kidney_factsheet.pdf

[7] https://www.cdc.gov/kidneydisease/basics.html

[8] https://www.cdc.gov/diabetes/basics/quick-facts.html

[9] https://www.cdc.gov/diabetes/data/statistics-report/coexisting.html

[10] Weekly / March 30, 2018 / 67(12);362–365 https://www.cdc.gov/mmwr/volumes/67/wr/mm6712a3.htm

[11] Diabetes Care 2012 Sep; 35(9): 1814-1816. https://doi.org/10.2337/dc12-0749

[12] Diabetes Care 2017 Jan; 40(Supplement 1): S114-S119. https://doi.org/10.2337/dc17-S016

[13] https://www.cdc.gov/reproductivehealth/contraception/unintendedpregnancy/index.htm

[14] BMC Public Health. 2012; 12: 792. doi: 10.1186/1471-2458-12-792

[15] https://www.heart.org/en/health-topics/diabetes/why-diabetes-matters/cardiovascular-disease--diabetes

[16] "The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus". The New England Journal of Medicine. 1993. 329(14):977-986.

[17] "Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes". The Lancet. 1998. 352(9131):837-53.

[18] "Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes". The New England Journal of Medicine. 2008. 358(24):2560-2572.

[19] Turner R, et al. "Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes". The Lancet. 1998. 352(9131):837-53.

[20] "The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus". The New England Journal of Medicine. 1993. 329(14):977-986.

[21] Neal B, et al. "Canagliflozin and cardiovascular and renal events in type 2 diabetes". The New England Journal of Medicine. 2017. 377(7):644-657.

[22] "The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus". The New England Journal of Medicine. 1993. 329(14):977-986.

[23] Diabetes Care. 2015 Oct;38(10):1876-82. doi: 10.2337/dc15-0780. Epub 2015 Aug 17.

[24] Diabetes Technol Ther. 2017 Jun 1; 19(Suppl 3): S-3–S-12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5467132/#B28

[25] Diabetes Ther. 2019 Nov 4. doi: 10.1007/s13300-019-00711-1

[26] J Matern Fetal Neonatal Med. 2016;29(14):2252-8. doi: 10.3109/14767058.2015.1081888. Epub 2015 Sep 11.

[27] Marso SP, et al. "Liraglutide and cardiovascular outcomes in type 2 diabetes". The New England Journal of Medicine. 2016. 375(4):311-322.

[28]Gerstein HC et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet 2019. 394:121-130.

[29] EMPA-REG, CANVAS,  PROactive,  IRIS

[30] Diabetes Care 2019 Jan; 42(Supplement 1): S90-S102. https://doi.org/10.2337/dc19-S009

[31] https://www.ihs.gov/sites/sdpi/themes/responsive2017/display_objects/documents/factsheets/SDPI_FactSheet_July2017.pdf


[33] Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2017.

[34] https://www.cdc.gov/kidneydisease/pdf/kidney_factsheet.pdf

[35] J Am Board Fam Med. 2018 Nov-Dec;31(6):905-916. doi: 10.3122/jabfm.2018.06.180075.

[36] https://www.kff.org/uninsured/issue-brief/key-facts-about-the-uninsured-population/

[37] JAMA. 2016;315(13):1400-1402. doi:10.1001/jama.2016.0126

[38] JAMA. 2016;315(13):1400-1402. doi:10.1001/jama.2016.0126

[39] Am J Pharm Benefits. 2010;2(1):50-58


[i] https://www.nejm.org/doi/full/10.1056/NEJM199309303291401

[ii] N Engl J Med 2016; 375:1834-1844    DOI: 10.1056/NEJMoa1607141

Staff support for this policy statement was provided by:

Kate Sullivan Hare, MHSA; and Michael Williams, JD