Type 1 Diabetes Clinical Trial
— HAD-1Official title:
Clinical Factors Determining the Occurrence of Impaired Awareness of Hypoglycemia (IAH) in Adult Patients With Type 1 Diabetes
NCT number | NCT05620927 |
Other study ID # | 795/22 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 24, 2022 |
Est. completion date | December 31, 2023 |
The goal of this observational study is to assess clinical factors associated with the occurrence of impaired hypoglycemia awareness in adult patients with type 1 diabetes The main questions it aims to answer are: 1. Determination of the prevalence of impaired hypoglycemia awareness (IAH) in adult patients with type 1 diabetes in the Polish population. 2. Assessment of the clinical usefulness of commonly used standardized scales for the assessment of IAH. 3. Determination of the clinical factors associated with the occurrence of impaired hypoglycemia awareness in adult patients with type 1 diabetes. 4. Determination of the relationship between the occurrence of IAH and the diagnosis of cardiac autonomic neuropathy. 5. Determination of the relationship between impaired hypoglycemia awareness in adult patients with type 1 diabetes and the occurrence of cognitive impairment. Participants will: - fill the standard questionnaires regarding hypoglycemia awareness: Gold, Clarck, HypoA-Q. - have late complications of diabetes checked - have procedure of cardiac autonomic neuropathy assessment - have standard laboratory evaluation during hospitalization
Status | Recruiting |
Enrollment | 245 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Type 1 diabetes - Duration of diabetes > 10 years - Consent to participate in the study Exclusion Criteria: - Age under 18 - Duration of diabetes> 10 years - Neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, Huntington's disease) - Multiple sclerosis - Mental disorders - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Medical Sciences | Poznan |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impaired awareness of hypoglycemia (IAH) - HypoA-Q | Determination of the prevalence of impaired hypoglycemia awareness (IAH) in adult patients with type 1 diabetes in the Polish population in % in the study population measured by the HypoA-Q. | one year | |
Primary | Impaired awareness of hypoglycemia (IAH) - Gold Questionnaire | Determination of the prevalence of impaired hypoglycemia awareness (IAH) in adult patients with type 1 diabetes in the Polish population in % in the study population measured by the Gold scale.
Gold Questionnaire contains one question asking individuals to report their experience of detecting hypoglycemic events with a score ranging from 1 (always aware) to 7 (never aware) on the Likert scale. |
one year | |
Primary | Impaired awareness of hypoglycemia (IAH) - Clarke's Questionnaire | Determination of the prevalence of impaired hypoglycemia awareness (IAH) in adult patients with type 1 diabetes in the Polish population in % in the study population measured by the Clarke's Questionnaire - Consists of eight questions assessing the prior experience of hypoglycemia, such as a history of severe hypoglycemia development and blood glucose levels at which patients begin to detect symptoms of hypoglycemia. The questionnaire generates a score (0-7) based on the patient's responses. | one year | |
Secondary | diagnosis of cardiac autonomic neuropathy. | measurement of heart rate variability using the CARDIOSYS EXTRA system (MDE GmbH). It is a non-invasive method. The patient's heart rate variability under the influence of certain standardized stimuli is tested (supine test, deep breathing test, Valsalva maneuver, orthostatic test, hand grip test). During the examination, the ECG of the examined person is monitored on the computer screen. The program recognizes R waves and calculates successive R-R intervals and their variability. Based on the calculated differences in R-R intervals, specific parameters for the assessment of autonomic neuropathy are calculated and compared with the norm values for age and gender. Autonomic neuropathy is diagnosed if two of the four tests are abnormal | one year | |
Secondary | Hypoglycemia Fear Survey | HFS-II questionnaire (Hypoglycemia Fear Survey) - questionnaire assessing fear of hypoglycemia in the last four weeks. It consists of two subscales. The first: Behavior contains 15 questions about what to do to avoid low blood glucose and its consequences. Second: Concerns includes 18 questions about concerns about low blood glucose levels. For each question, the patient scores between 0 (never) and 4 (almost always). The results are the sum of points separately for each subscale. The higher the score, the greater the fear of hypoglycemia. | one year | |
Secondary | occurrence of cognitive impairment | MOCA Questionnaire - Montreal Cognitive Assessment Scale - a tool for screening the assessment of mild cognitive impairment. The 10-minute test allows you to assess attention and concentration, executive functions, memory, language, visual and spatial functions, conceptual thinking, calculation skills and orientation. The maximum number of points that can be obtained is 30. A score below 26 points suggests a cognitive impairment. | one year |
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