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At T1D Exchange, our Outcomes Research team collaborates with leaders in the diabetes space to design studies to understand the preferences, experiences, and quality of life of people living with diabetes in our registry and online community.
If you are the T1D Exchange Registry, you’ve likely seen research study opportunities on your dashboard. You may have even participated in some of these studies! Thousands of our registry participants participated in the research studies featured in this article.
In this article, we’ll dive into recent research publications and presentations from the work of the T1D Exchange Research team and our partners.
Learn more about our findings from each of these research studies:
- Limitations in Achieving Glycemic Targets from CGM Data and Persistence of Severe Hypoglycemia in Adults with Type 1 Diabetes Regardless of Insulin Delivery Method
- The Psychosocial Burden of Severe Hypoglycemic Events and Impaired Awareness of Hypoglycemia in Adult Continuous Glucose Monitor Users: Results from a Cross-Sectional Survey Study
- Life and Work Productivity Impairment in Adult Continuous Glucose Monitor Users with Type 1 Diabetes: Results from a Cross-Sectional Survey Study
- Impact of SHE Frequency and IAH Status on Sleep Quality in Adult Continuous Glucose Monitor Users with Type 1 Diabetes: Results from a Cross-Sectional Survey Study
- Using Distribution-Based Methods to Determine Minimal Important Differences with the Hypoglycemia Fear Survey-II in Adults with Type 1 Diabetes
Limitations in Achieving Glycemic Targets From CGM Data and Persistence of Severe Hypoglycemia in Adults With Type 1 Diabetes Regardless of Insulin Delivery Method
We conducted this research with our partners at Vertex Pharmaceuticals, Inc. and experts at academic medical centers. For this study, we captured and linked survey responses with continuous glucose monitoring (CGM) data for adults with type 1 diabetes in the T1D Exchange Registry to see how glycemic outcomes varied between insulin delivery methods.
Despite the use of the latest diabetes technologies, a portion of people are not reaching recommended glycemic targets (A1C < 7.0% and time-in-range > 70%) and are experiencing severe hypoglycemia.
Out of 926 adult CGM users with type 1 diabetes:
- 51% used automated insulin delivery (AID) systems
- 32% used conventional insulin pumps
- 17% used multiple daily injections (MDI)
Participants who reported severe hypoglycemic events in the previous 12 months:
- AID users: 16%
- Pump users: 16%
- MDI users: 19%
Proportion of participants meeting time-in-range >70%:
- AID users: 72%
- Pump users: 49%
- MDI users: 50%
Proportion of participants with A1C below 7.0%:
- AID users: 77%
- Pump users: 63%
- MDI users: 57%
Although more participants using AID systems met A1C and CGM targets compared to participants using other insulin delivery methods, about 28% of AID users did not meet the time-in-range target of >70%.
Severe Hypoglycemia in Adult Continuous Glucose Monitor Users with Type 1 Diabetes: Results From a Cross-Sectional Survey Study
The following findings were presented at the ISPOR Europe 2024 conference in November 2024. We conducted this research with our partners at Vertex Pharmaceuticals, Inc.
Results are from a large study in which we surveyed 1,847 CGM users with type 1 diabetes in the T1D Exchange Registry to better understand how different experiences of severe low blood sugar (severe hypoglycemic events, or “SHE”) and not recognizing the symptoms of low blood sugar (impaired awareness of hypoglycemia, or “IAH”) may create differences in health-related quality of life and diabetes-related well-being.
To do this, participants were grouped by their recent self-reported SHE experiences and their measured IAH into the following:
- Problematic SHEs (those with 2 or more severe lows in the past year and those with only 1 severe low but also IAH)
- Single SHE (those with only 1 severe low without IAH)
- Undetermined IAH (those with any SHEs but with an IAH score that could not be categorized)
- No SHEs (those with zero SHEs with or without IAH)
Across multiple measures and despite the use of advanced diabetes technologies, health-related quality of life was lower in people who experience multiple SHEs or only one SHE but who have IAH.
The results of these studies highlight the ongoing challenges people with type 1 diabetes face and further suggest there is an especially vulnerable group of individuals (Problematic SHE group) who may benefit from additional interventions or innovative treatments to reduce the burden.
Read more about each presentation below!
Psychosocial Burden
The first presentation explored psychosocial burden — measured by fear of hypoglycemia and general anxiety or depression — in people with different SHE and IAH experiences.
Compared to those with No SHEs, participants in the Problematic SHE group had a greater psychosocial burden. They had higher rates of a self-reported diagnosis of anxiety or depression, higher current symptoms of anxiety and depression, and greater fear of hypoglycemia.
The higher levels of psychological distress in the Problematic SHE group were present regardless of which insulin delivery methods participants used.
Life and Work Productivity Impairment
The second presentation explored type 1 diabetes-related impacts on life and work productivity in people with different SHE and IAH experiences.
Regardless of which insulin delivery system participants used, participants in the Problematic SHE group reported a higher negative impact of diabetes on their daily lives and work productivity compared to participants in the No SHE group. These findings were consistent across various insulin delivery methods.
Sleep Quality
The third presentation explored self-reported sleep quality in people with different SHE and IAH experiences.
Generally compared to the No SHE group, participants in the Problematic SHE group more frequently reported having a sleep disorder. Moreover, except for participants who used an insulin pump (without automation), most participants in the Problematic SHE group also reported lower sleep quality compared to the no SHE group.
Determining Minimal Important Differences with the Hypoglycemia Fear Survey-II
The fourth presentation used our sample to determine some guidelines for a meaningful change in the reported level of fear of hypoglycemia. We used the survey data to calculate the minimum clinically important difference needed to suggest that fear of hypoglycemia has improved. This study aimed to help establish research-based guidelines that could be used in type 1 diabetes research or in provider offices that use the Hypoglycemia Fear Survey-II.
In our sample, the average score of fear of hypoglycemia was 40.2. Using several distribution-based calculations, we found that a change of 5 to 11 points would indicate a meaningful difference in fear of hypoglycemia.
As our sample did not capture participants more than one time, we compared levels of fear of hypoglycemia in our study to another published study using the HSF-II (Frederick, 2011). Between these two samples, the fear of hypoglycemia had not improved over time.
Do you want to be notified about diabetes research opportunities? Join the T1D Exchange Registry by filling out a short online survey about everyday life with T1D. Once enrolled, we will let you know about other T1D research opportunities like surveys, focus groups, and clinical trials.
