The current study aims to assess the impact of self-quarantine on glycemic control. In addition, this study describes diabetes self-management, well-being and distress in Dutch patients with type 1 and type 2 diabetes, during a nationwide period of…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the effect of a period of nationwide self-quarantine on glycemic
control, assessed by HbA1c, in patients with type 1 and type 2 diabetes
Secondary outcome
- To determine the effect of a period of nationwide self-quarantine on glucose
variability assessed by the standard deviation (SD) of glucose values (glucose
variability) in patients with type 1 and type 2 diabetes
- To assess the association between (diabetes) distress and glycemic control
during a period of nationwide self-quarantine. (Diabetes) distress will be
measured by *Perceived Stress Scale*(PSS) and *Problem Areas in
Diabetes* (PAID).
- To assess the association between well-being and glycemic control during a
period of nationwide self-quarantine. Well-being will be measured by the WHO-5.
- To assess the association between between diabetes self-management and
glycemic control during a period of nationwide self-quarantine. Self-management
behaviour will be measured by the *Summary of Diabetes Self-Care
Activities* (SDSCA) and *Diabetes Self-Management Questionnaire-rev.* (DSMQ-R)
- To determine differences HbA1c, glucose variability, well-being, distress and
self-management between patients with type 1 and type 2 diabetes
Background summary
The last few months have been characterized by the viral outbreak of COVID-19
and the measures and precautions that came along with this pandemic. In all
affected countries these strategies required major adaptations of behavioral
patterns, social activities and employment of the population.
Such sudden and major disruptions from every-day-life are known to influence
both mental and physical health. Recent studies describing the psychological
impact of quarantine, showed that experiencing quarantine is related to a wide
range of stress and mood related symptoms, such as depression, anxiety,
irritability, poor concentration, insomnia and post-traumatic stress disorder
(PTSD). Longer periods of quarantine have been associated with increased
chances of developing PTSD. In addition, several studies suggest that such
symptoms might even last long after ending quarantine.
Recent studies and global media suggest that individuals with diabetes mellitus
(DM) are more likely to be infected and are at a higher risk for complications
and death from COVID-19. People with diabetes and their relatives may therefore
experience increased feelings of stress, fear and anxiety regarding the risk of
being infected with COVID-19. And additionally, may put even greater emphasis
on the importance of self-quarantine.
Emotional distress as well as changes in daily structures and behaviors are
known to influence diabetes self-management and glucose regulation.
Maintaining glycemic control during self-quarantine can therefore be
challenging. Alterations in physical activity, diet and daily patterns may
result in an imbalance between blood glucose values and the amount of insulin
injected or other drugs prescribed, resulting in glycemic dysregulation
Study objective
The current study aims to assess the impact of self-quarantine on glycemic
control. In addition, this study describes diabetes self-management, well-being
and distress in Dutch patients with type 1 and type 2 diabetes, during a
nationwide period of self-quarantine.
It is hypothesized that experiencing this period of nationwide quarantine
influences glycemic control and that patients reporting severe distress or low
well-being experience more problems in regard to diabetes self-management and
maintaining glycemic control than those without psychological distress or low
well-being.
Study design
This is an observational cross-sectional study.
Patiënts will perform an HbA1c fingerprik, fill out a questionnaire about
stress, general well-being and self-management and data of the continuous or
FreeStyle Libre sensor over the last 3 months (only if they have a sensor) will
be collected, once.
Study burden and risks
The burden of participation exists out of the fingerprick measurement of the
HbA1c. Participation in this study will cost the patient circa 60 minutes of
their time. The HbA1c fingerprick measurement can result in a short-lasting
period of discomfort. However, many patients with diabetes peform such
fingerprick measurements regularly to measure their blood glucose values.
The risk of participation is low. Potentially filling out the questionnaires on
distress and well-being may result in an increased focus on these feelings.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Type 1 or type 2 diabetes mellitus
- 18 years or older
- Ability to perform fingerprick HbA1c self-measurement
- Sufficient Dutch language comprehension
- Ability to fill out online questionnaire
Exclusion criteria
- Pregnancy
- Newly diagnosed malignancy, with the exclusion of non-melanoma skin cancer,
in the previous 6 months
- Chemotherapy or immunotherapy for malignancy
- Admission to hospital or rehabilitation center
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL73778.058.20 |