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Type 1 Diabetes MellitusNCT04558645

Evaluation of Quality of Life in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic

An observational study of Type 1 Diabetes Mellitus and Covid19, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

During the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus, Covid19
What is being tested?
Online Survey
How many people
118 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Sep 2020to 26 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with type 1 diabetes mellitus and healthy controls between 18-65 years

Who may be able to join

  • Having been diagnosed with Type 1 Diabetes Mellitus
  • Willing to participate in the study
  • Participants whose native language is Turkish

Who cannot join

  • Unwilling to participate in the study
  • Having a cognitive disorder
  • Not being literate
  • Individuals who do not have sufficient knowledge and functional levels to fill out the online form

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Zeliha ÇELİK

    Ankara, Çankaya, 06490

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Quality of Life, Physical Activity and Depression in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic

During the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. These reasons have prevented being physically active. The aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic period and compared with healthy controls.

Being tested
Online Survey
Medical subject headings
Diabetes Mellitus, Type 1, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online SurveyOther

    Online surveys will be applied to all participants

Study groups in NCT04558645
Study groupRoleWhat they receive
Patients with type 1 diabetes mellitusPatients with Type 1 diabetes mellitus willing to participate in the study
Receives: Other: Online Survey
Healthy controlsHealthy controls without chronic disease willing to participate in the study
Receives: Other: Online Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity level

    Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.

    Measured: Five minutes

  2. General Quality of life

    Quality of life using Short Form Health Survey (SF-36) will be evaluated.

    Measured: Ten minutes

Secondary outcomes (6)

  1. Depression

    Depression using Hospital Anxiety and Depression Scale will be evaluated.

    Measured: Three minutes

  2. Anxiety

    Anxiety using Hospital Anxiety and Depression Scale will be evaluated.

    Measured: Three minutes

  3. Self-reported hypoglycemia

    It will be questioned how many times patients have had hypoglycemic attacks (<4 mmol/L and common symptoms) in the last 7 days.

    Measured: Last seven day

  4. Loneliness

    Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.

    Measured: Three minutes

  5. Hypoglisemia fear

    Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.

    Measured: Five minutes

  6. Dyspnea

    Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.

    Measured: Two minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start18 Sep 2020
  3. Primary completion18 Dec 2020
  4. Study completion26 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558645
Sponsor's protocol ID
91610558-604.01.02
Status last verified
Dec 2020
First submitted
18 Sep 2020
Last updated
29 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus and Covid19, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity level (time frame: Five minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04558645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

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