Current State of Impaired Awareness of Hypoglycaemia in People With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT04311021|
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Hypoglycaemia is the most frequent complication of insulin treatment in individuals with type 1 diabetes and a limiting factor for achieving optimal glycaemic control. When recurrent, hypoglycaemia can induce a process of habituation, leading to impaired awareness of hypoglycaemia (IAH), a process that can be reversed by meticulous avoidance of hypoglycaemia. In the past 5-10 years, the use of continuous real-time (RT-CGM) or flash glucose monitoring (FGM) has increased rapidly in the clinical management of type 1 diabetes to improve overall glycaemic control and reduce the frequency of hypoglycaemic events, in particular in patients with IAH. It is unknown, however, whether the use of these devices, as well as other improvements in clinical management, has reduced the prevalence IAH and exposure to severe hypoglycaemia (SH) in subjects with type 1 diabetes in a real-world setting. Therefore, it becomes highly appropriate to investigate the current state of IAH and SH in type 1 diabetes. Also, since invites to this study will specifically include people who have taken part of previous assessments, this study will be able to investigate the change in IAH over time and the potential contributing role of RT-CGM/FGM. Furthermore, we want to explore associations of IAH and SH with clinical parameters, quality of life and psychosocial impact. This knowledge will help people with diabetes and their healthcare providers to better adjust treatment recommendations to individual targets.
The primary objective of our study is to investigate the current prevalence of IAH and exposure to severe hypoglycaemia in individuals with diabetes type 1.
The secondary objectives of our study are to:
- Study the difference in IAH prevalence over time in individuals with diabetes type 1.
- Assess the association of RT-CGM/FGM with IAH and SH.
- Study thoughts, emotions and worries which lead to a certain behaviour in case of hypoglycaemia and prevention of hypoglycaemia.
- Study associations of IAH and history of SH with productivity in different situations (work/study, relation/sexuality, driving behaviour/traffic and sport/leisure).
- Study association between partner involvement and handling in case of (unawareness for) hypoglycaemia.
- Study knowledge of subjects with diabetes about hypoglycaemia and IAH.
- Study burden of IAH and severe hypoglycaemia on family members of people with type 1 diabetes, as experienced by patients themselves.
This study will be a cross-sectional observational cohort study. The study will be conducted at the Radboud university medical center, department of internal medicine. Subjects with type 1 diabetes will be recruited from outpatient diabetes clinic as well as subjects who participated in two earlier cohorts and agreed to be approached again.
The study population will be individuals with diabetes type 1, older than sixteen years old.
Main study parameters/endpoints The main study parameter will be the current prevalence of IAH and exposure to severe hypoglycaemia in the past 12 months.
|Condition or disease||Intervention/treatment|
|Diabetes type1||Other: No intervention|
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Current State of Impaired Awareness of Hypoglycaemia in People With Type 1 Diabetes; Change in Prevalence, Impact of Glucose Monitoring Technology and Psychosocial Impact|
|Actual Study Start Date :||January 23, 2020|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2021|
|Diabetes type 1||
Other: No intervention
- The main study parameter will be the current prevalence of IAH and exposure to SH in the past 12 months. [ Time Frame: Past 12 months ]
- Difference in IAH prevalence over the years. [ Time Frame: Past 12 years. ]
- Relationship between IAH/SH prevalence and RT-CGM/FGM vs traditional glucometer use. [ Time Frame: Past 12 months. ]
- Answers to questionnaire [ Time Frame: Past 12 months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311021
|Contact: Namam Ali, Drs +31243616504 Namam.Ali@radboudumc.nl|
|Principal Investigator: Namam Ali|