Diabetes mellitus is a chronic disease characterized by the inability of the body to maintain normoglycemia. Treatment of diabetes relies mostly on diabetes self-management, requiring a large investment of time and energy on a daily basis. Psychological wellbeing, behavioral patterns and social context play a major role in diabetes self-management and glycemic control. Social isolation behavior (self-quarantining) may impact glycemic control by influencing daily routines, therapy adherence, physical activity, and self-measurement and eating behaviors. Therefore, a period of nationwide self-quarantine, such as during the lockdown issued during the COVID-19 outbreak in the Netherlands, may have a large effect on glycemic control in patients with diabetes. In this observational cross sectional study, we aim to assess the impact of long-term self-quarantine on glycemic control, diabetes self-management and distress in patients with type 1 and type 2 diabetes mellitus. A specific subgroup of patients with T1D are those with complicated diabetes who have received a pancreas or islet transplantation and use immunosuppression, having multiple risk factors for severe COVID-19. The impact of lockdown strategies on mental and physical health is expectedly even greater in patients at even higher risk for severe COVID-19. We therefore additionally investigated differences in behavioral, mental and physical implications of a nationwide lockdown on patients with type 1 diabetes with and without islet or pancreas transplantation. Measurements will be performed during the lockdown period. Patients will be asked to perform a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data from continuous or flash glucose monitoring devices will be collected according to standard clinical practice. Furthermore, patients will be asked to fill out an online questionnaire once on diabetes self-management behavior, well-being and distress, along with questions about health status, level of education, medication use, employment, social situation and the impact of self-quarantine on daily routines. In this questionnaire, we ask patients to compare certain aspects of their life (e.g. anxiety, stress, weight, physical activity, glycemic control) at the time of the lockdown to before the lockdown. Data on demographics, type of diabetes, weight, BMI and HbA1c prior to the COVID-19 outbreak will be derived from the patient's electronic health file.
Study Type
OBSERVATIONAL
Enrollment
492
Not applicable, no interventions, observational study
Leiden University Medical Center
Leiden, South Holland, Netherlands
Glycemic control
HbA1c (mmol/mol Hb)
Time frame: HbA1c measurement during lockdown (8 - 11 weeks after the start of the lockdown (March 15th 2020)) compared to last measurement before lockdown (last known measurement before March 15th 2020)
Glycemic control
Continuous Glucose Measurement parameters (time in range, time above range, time below range)
Time frame: 2 week period during lockdown compared to 2 week period before lockdown
Stress
Perceived Stress Scale (PSS) + self-reported change in stress during lockdown compared to before lockdown
Time frame: PSS During lockdown + self-comparison change to before lockdown (questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Anxiety
Self-reported change in anxiety during lockdown compared to before lockdown
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Weight
Self-reported weight change during lockdown compared to before lockdown
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Physical activity
Self-reported change in physical activity during lockdown compared to before lockdown
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Glycemic control and insulin requirements
Self-reported change in difficulty with glycemic control and insulin requirements during lockdown compared to before lockdown
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Social isolation behaviour
Self-reported social isolation behaviour during lockdown
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Fear of COVID-19 infection
Fear of contracting COVID-19, scored using a Visual Analogue Scale (1-10), during lockdown
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
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