Official Title
The Impact of Self-quarantining on Glycemic Control, Diabetes Self-management and Distress During the Coronavirus Outbreak
Brief Summary

Diabetes mellitus is a chronic disease characterized by the inability of the body tomaintain normoglycemia. Treatment of diabetes relies mostly on diabetes self-management,requiring a large investment of time and energy on a daily basis. Psychologicalwellbeing, behavioral patterns and social context play a major role in diabetesself-management and glycemic control. Social isolation behavior (self-quarantining) mayimpact glycemic control by influencing daily routines, therapy adherence, physicalactivity, and self-measurement and eating behaviors. Therefore, a period of nationwideself-quarantine, such as during the lockdown issued during the COVID-19 outbreak in theNetherlands, 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-termself-quarantine on glycemic control, diabetes self-management and distress in patientswith type 1 and type 2 diabetes mellitus.A specific subgroup of patients with T1D are those with complicated diabetes who havereceived a pancreas or islet transplantation and use immunosuppression, having multiplerisk factors for severe COVID-19. The impact of lockdown strategies on mental andphysical health is expectedly even greater in patients at even higher risk for severeCOVID-19. We therefore additionally investigated differences in behavioral, mental andphysical implications of a nationwide lockdown on patients with type 1 diabetes with andwithout islet or pancreas transplantation.Measurements will be performed during the lockdown period. Patients will be asked toperform a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data fromcontinuous or flash glucose monitoring devices will be collected according to standardclinical practice. Furthermore, patients will be asked to fill out an onlinequestionnaire once on diabetes self-management behavior, well-being and distress, alongwith questions about health status, level of education, medication use, employment,social situation and the impact of self-quarantine on daily routines. In thisquestionnaire, 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 tobefore the lockdown. Data on demographics, type of diabetes, weight, BMI and HbA1c priorto the COVID-19 outbreak will be derived from the patient's electronic health file.

Detailed Description

Not Provided

Completed
Type 1 Diabetes
Type 2 Diabetes

Other: No interventions, observational study

Not applicable, no interventions, observational study

Eligibility Criteria

Inclusion Criteria:

- Age ≥ 18 years

- Diagnosed with type 1 or type 2 diabetes

- Ability to perform fingerpricks

- Sufficient comprehension of the Dutch language

- Ability to fill out online questionnaires

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Netherlands
Locations

Leiden University Medical Center
Leiden 2751773, South Holland 2743698, Netherlands

Eelco JP de Koning, MD PhD, Principal Investigator
Leiden University Medical Center

Leiden University Medical Center
NCT Number
Keywords
COVID-19 pandemic
Type 1 Diabetes
Type 2 diabetes
Beta Cell Transplantation
Social Isolation
Glycemic control
Distress
COVID-19 lockdown
MeSH Terms
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
COVID-19
Social Isolation
Observation