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Current State of Impaired Awareness of Hypoglycaemia in People With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311021
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
HypoResolve
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Rationale:

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.

Objective:

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.

Study design:

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.

Study population:

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

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diabetes type 1 Other: No intervention
No intervention




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Difference in IAH prevalence over the years. [ Time Frame: Past 12 years. ]
  2. Relationship between IAH/SH prevalence and RT-CGM/FGM vs traditional glucometer use. [ Time Frame: Past 12 months. ]
  3. Answers to questionnaire [ Time Frame: Past 12 months. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects with diabetes type 1.
Criteria

Inclusion Criteria:

  • Type 1 diabetes diagnosis based on clinical judgement with or without auto-antibodies, according to the ISPAD Clinical Practice Consensus Guidelines 2018 (27). Briefly, clinical criteria for the diagnosis of diabetes mellitus include an acute presentation, classical symptoms of diabetes or profound hyperglycaemia with or without ketoacidosis, a plasma glucose concentration ≥11.1 mmol/L and considerably elevated HbA1c, and age of onset >6 months.
  • Age ≥16 years.
  • Ability to provide written informed consent.
  • Fluency in speaking and reading Dutch.

Exclusion Criteria:

  • Severe psychiatric comorbidity that leads to inability to provide informed consent or as judged by the healthcare provider
  • Other comorbidity interfering with completing surveys, as judged by the healthcare professional.

Information from the National Library of Medicine

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


Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: Namam Ali, Drs    +31243616504    Namam.Ali@radboudumc.nl   
Principal Investigator: Namam Ali         
Sponsors and Collaborators
Radboud University
HypoResolve

Additional Information:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04311021    
Other Study ID Numbers: NL-number: NL71207.091.19
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Hypoglycemia
Impaired awareness of hypoglycemia
Psychosocial impact
Epidemiology
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases