Patient-reported outcomes (PROs) are an increasingly important component of clinical trials, regulatory submissions, and consumer marketing. A recent dQ&A PRO measurement of n=4,890 adults with diabetes yielded detailed self-reported data on hypoglycemia episodes, and found that reduced hypoglycemia awareness is common in both type 1 and type 2 diabetes. Increased use of continuous glucose monitoring and automated insulin delivery devices can help address this problem.
SAN FRANCISCO, California, November 22, 2019 — dQ&A, the leader in diabetes patient research, released selected results from its recent patient-reported outcomes (PRO) study focused on hypoglycemia unawareness.
Hypoglycemia unawareness is a dangerous condition in which people with diabetes lose the typical warning signs of impending hypoglycemia, such as a higher pulse rate, sweating, anxiety, or feelings of danger. Without these warnings (or access to CGM), people can’t take the opportunity to self-treat (e.g., with glucose tablets) and can quickly lose cognitive function and become dependent on another person for help. The negative effects of unexpected hypoglycemia range from confusion, unconsciousness, and seizures, to, in rare cases, death.
Reduced Hypoglycemia Awareness is Common
Recurrent hypoglycemia (of any severity) can lead to hypoglycemia unawareness, which is in turn associated with more hypoglycemia and more risk. Using a validated measure known as the Clarke Hypoglycemia Awareness Survey1, the dQ&A study showed that one in three respondents with type 1 diabetes have reduced hypoglycemia awareness, indicating that they often do not experience symptoms when their blood glucose is low.
|Adults with type 1 diabetes (n=1,778)||Adults with type 2 diabetes taking insulin (n=1,490)||Adults with type 2 diabetes not taking insulin (n=1,622)|
|Reduced hypoglycemia awareness (Clarke PRO measurement)||33%||10%||5%|
Shocking Self-Reported Rate of Incapacitating Hypoglycemia
The study also revealed a worryingly high rate of hypoglycemia requiring the intervention of another person, including among people with type 2 diabetes. The Clarke Hypoglycemia Awareness Survey defines ‘moderate’ hypoglycemia as an episode where the patient was unable to treat themselves. This definition is often used to denote ‘severe’ hypoglycemia in clinical trials, and is clearly clinically significant. Around half of respondents taking insulin had experienced this type of ‘moderate’ hypo within the last six months (see table). It’s notable that this patient-reported hypoglycemia measurement is much higher than typical clinical data from trials. This effect is often seen in PRO data.
|Frequency of moderate hypoglycemia episodes in the past 6 months (“episodes where you might feel confused, disoriented, or lethargic and were unable to treat yourself”)|
|Adults with type 1 diabetes (n=1,777)||Adults with type 2 diabetes taking insulin (n=1,489)||Adults with type 2 diabetes not taking insulin (n=1,622)|
|Once or twice||24%||29%||19%|
|Every other month||4%||4%||2%|
|Once a month||7%||6%||2%|
|More than once a month||14%||8%||2%|
The data for ‘severe’ hypoglycemia (defined as falling unconscious, having a seizure or needing glucagon or intravenous glucose) were also shocking (see table). For example, 10% of type 1 patients had experienced this emergency situation in the last year and 2% had experienced it four or more times.
|Frequency of severe hypoglycemia episodes in the past year (“episodes where you were unconscious or had a seizure or needed glucagon or intravenous glucose”)|
|Adults with type 1 diabetes (n=1,772)||Adults with type 2 diabetes taking insulin (n=1,486)||Adults with type 2 diabetes not taking insulin (n=1,618)|
|4 or more times||2%||2%||1%|
“Patient-reported outcomes are becoming increasingly important in building a truthful picture of diabetes,” said Richard Wood, dQ&A’s CEO. “This study underscores that incapacitating hypoglycemia is more common than some people think in both type 1 and type 2 diabetes, that reduced hypoglycemia awareness is also very common, particularly in type 1, and that we should focus on increasing access to existing medicines and devices that help people prevent and manage hypoglycemia – such as continuous glucose monitoring and automated insulin delivery.”
dQ&A uses PROs to provide statistically valid insights from patients about their own health, quality of life, and functional status. We believe strongly in their importance, since they help put real-world patient experiences at the center of the development process for therapies, products, and services.
Please contact Richard Wood at email@example.com for more information about this piece of research, or for inquiries into dQ&A’s industry-leading services.
dQ&A would like to express its sincere gratitude to all of the community members who participated in this research study.
- The Clarke Hypoglycemia Awareness Survey is an 8-item self-reported scale used to determine a person’s level of hypoglycemia awareness. Clarke WL, Cox DJ, Gonder-Frederick LA, Julian D, Schlundt D, Polonsky W: Reduced awareness of hypoglycemia in adults with IDDM: a prospective study of hypoglycemic frequency and associated symptoms. Diabetes Care 18:517–522, 1995. https://doi.org/10.2337/diacare.18.4.517
About dQ&A – The Diabetes Research Company
dQ&A is a social enterprise that’s committed to making life better for people with diabetes. We harness patient voices to help develop better products, services and policies, answer key business questions and improve health outcomes for people with diabetes. For ten years, we have focused exclusively on understanding what life is like for those with diabetes. We are trusted by patients because of our independence and commitment to them. And we are endorsed by industry leaders because we deliver high quality answers quickly and efficiently, through the use of our proprietary community. Our team has decades of experience in quantitative and qualitative research and a deep knowledge of diabetes. Many of our lives have been touched by diabetes, so we have a personal stake in our work.