Impaired Awareness of Hypoglycemia

A common condition among those with type 1 diabetes is difficulty in recognizing when their glucose levels are low. This condition, called impaired awareness of hypoglycemia (IAH), can be dangerous because people cannot tell by symptoms that they need to take action to bring glucose levels up.

Facts about Impaired Awareness of Hypoglycemia

  • On average, a person with type 1 diabetes (T1D) has two episodes of hypoglycemia per week and during their life they could have episodes of severe hypoglycemia requiring help from others.
  • Hypoglycemic episodes induce physiological counter-regulatory responses (CRR) and behavioral defenses that prevent severe hypoglycemia or subsequent hypoglycemic episodes. These mechanisms are impaired in T1D, and particularly in those with IAH.
  • Single episodes of long duration hypoglycemia or two episodes of short duration moderate hypoglycemia blunt CRR and may lead to impaired awareness of hypoglycemia.
  • Therefore, IAH is more common among those who experience low blood glucose levels frequently, or those who have been living with Type 1 diabetes for ten years or more.
  • Some degree of impaired awareness of hypoglycemia can be present in 1 in 4 adults with type 1 diabetes for more than 10 years.
  • Episodes of hypoglycemia are not only uncomfortable and disruptive, but severe hypoglycemia can involve loss of consciousness, falls, fractures, accidents, and seizures. Understanding and preventing IAH is crucial to reduce these risks.
  • IAH increases the risk of severe hypoglycemia by 6-fold.
  • IAH still increases the risk of severe hypoglycemia even in the presence of new technologies such as CGM.
  • The best method to avoid or treat IAH is not clear. Small studies indicated that avoiding hypoglycemia through specially designed training programs, technology (glucose sensors and automated insulin delivery systems), psycho-behavioral interventions, and islet cell transplantation could restore hypoglycemic awareness.

Information about CLEAR

  • The CLEAR study will examine the effect of two types of interventions: psycho-education (state of the art targeted programs, group sessions, aimed at increasing sensitivity to symptoms and giving the support tools to people to treat hypos earlier before they get more severe) and diabetes technology (automated insulin delivery systems or hybrid closed loop systems). We will examine the effect of these interventions on the individual’s physiological ability to produce counter-regulatory hormones and their subjective awareness of their symptoms of low blood glucose.
  • Ultimately, the CLEAR study aims to reduce the frequency of severe hypoglycemia, and reduce diabetes distress.
  • CLEAR is enrolling adults with type 1 diabetes for 10 or more years and IAH.
  • People already on CGM, pumps, HCL can join and still benefit from the treatments.
  • All study participants will be treated with a HCL system and will be onboarded by the study team.
  • For more information, please follow the following link to ClinicalTrials.gov.

Library

  1. Frier BM. Nat Rev Endocrinol. 2014;10:711-722.
  2. Rickels MR. Ann N Y Acad Sci 2019 Oct;1454(1):68-79