Clinical trial NCT05977205: COVID-19 Glycemic Control Study
Official title: The Impact of Self-quarantining on Glycemic Control, Diabetes Self-management and Distress During the Coronavirus Outbreak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: COVID-19 Pandemic
Type 1 Diabetes
Type 2 Diabetes
Beta Cell Transplantation
Social isolation
Glycemic control
Distress
COVID-19 Lockdown
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes (with and without islet or pancreas transplantation) and type 2 diabetes, recruited from the diabetes outpatient clinic of the LUMC.

Brief summary: 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.


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

Primary outcomes:
measure: Glycemic control
timeFrame: 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)
Secondary outcomes:
measure: Glycemic control
timeFrame: 2 week period during lockdown compared to 2 week period before lockdown
measure: Stress
timeFrame: 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))
measure: Anxiety
timeFrame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
measure: Weight
timeFrame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
measure: Physical activity
timeFrame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
measure: Glycemic control and insulin requirements
timeFrame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
measure: Social isolation behaviour
timeFrame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
measure: Fear of COVID-19 infection
timeFrame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Eelco JP de Koning, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: