COVID-19 Glycemic Control Study

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

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Other: No interventions, observational study

• Study Type: Observational
• Enrollment (Actual): 492

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 1 Diabetes; 280 patients with type 1 diabetes	Other: No interventions, observational study; Not applicable, no interventions, observational study
Type 2 Diabetes; 155 patients with type 2 diabetes	Other: No interventions, observational study; Not applicable, no interventions, observational study
Type 1 Diabetes with Islet or Pancreas Transplantation; 23 patients with islet transplantation, 7 with pancreas transplantation, 27 with simultaneous pancreas-kidney transplantation	Other: No interventions, observational study; Not applicable, no interventions, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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))
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))
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))
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))
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))
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))
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))

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Eelco JP de Koning, MD PhD, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2020
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Type 1 Diabetes; Distress; Glycemic control; COVID-19 Pandemic; Social isolation; Beta Cell Transplantation; COVID-19 Lockdown
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: NL73778.058.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No