COVID-19 Glycemic Control Study

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05977205
• Other study ID #: NL73778.058.20
• Status: Completed
• Start date: May 2, 2020
• Est. completion date: July 10, 2020

Study information

• Verified date: August 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Other:
• No interventions, observational study
Not applicable, no interventions, observational study

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	HbA1c (mmol/mol Hb)	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	Glycemic control	Continuous Glucose Measurement parameters (time in range, time above range, time below range)	2 week period during lockdown compared to 2 week period before lockdown
Secondary	Stress	Perceived Stress Scale (PSS) + self-reported change in stress during lockdown compared to before lockdown	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))
Secondary	Anxiety	Self-reported change in anxiety during lockdown compared to before lockdown	Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Secondary	Weight	Self-reported weight change during lockdown compared to before lockdown	Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Secondary	Physical activity	Self-reported change in physical activity during lockdown compared to before lockdown	Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Secondary	Glycemic control and insulin requirements	Self-reported change in difficulty with glycemic control and insulin requirements during lockdown compared to before lockdown	Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Secondary	Social isolation behaviour	Self-reported social isolation behaviour during lockdown	Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Secondary	Fear of COVID-19 infection	Fear of contracting COVID-19, scored using a Visual Analogue Scale (1-10), during lockdown	Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))