NCT05620927

Brief Summary

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:

  • 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 24, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

November 6, 2022

Last Update Submit

November 24, 2022

Conditions

Type 1 DiabetesHypoglycemia UnawarenessCardiac Autonomic Neuropathy

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • diagnosis of cardiac autonomic neuropathy.

    one year

  • Hypoglycemia Fear Survey

    one year

  • occurrence of cognitive impairment

    one year

Study Arms (1)

Type 1 diabetes

Type 1 diabetes \> 10 years duration of diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with type 1 diabetes

You may qualify if:

  • Type 1 diabetes
  • Duration of diabetes \> 10 years
  • Consent to participate in the study

You may not qualify if:

  • Age under 18
  • Duration of diabetes\> 10 years
  • Neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, Huntington's disease)
  • Multiple sclerosis
  • Mental disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 60-834, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood smple: A1c, lipids, creatinine, TSH, cortisol urine: albumine / creatinine ratio

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Aleksandra Araszkiewicz

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Araszkiewicz

CONTACT

608574382olaaraszkiewicz@ump.edu.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 17, 2022

Study Start

November 24, 2022

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)