NCT05977205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

July 31, 2023

Last Update Submit

August 2, 2023

Conditions

Type 1 DiabetesType 2 Diabetes

Keywords

COVID-19 PandemicType 1 DiabetesType 2 DiabetesBeta Cell TransplantationSocial isolationGlycemic controlDistressCOVID-19 Lockdown

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Glycemic control

    2 week period during lockdown compared to 2 week period before lockdown

  • Stress

    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

    Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))

  • Weight

    Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))

  • Physical activity

    Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))

  • +3 more secondary outcomes

Study Arms (3)

Type 1 Diabetes

280 patients with type 1 diabetes

Other: No interventions, observational study

Type 2 Diabetes

155 patients with type 2 diabetes

Other: 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

Interventions

No interventions, observational studyOTHER

Not applicable, no interventions, observational study

Type 1 DiabetesType 1 Diabetes with Islet or Pancreas TransplantationType 2 Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Chemotherapy or immunotherapy for malignancy
  • Admission to hospital or rehabilitation center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

  • Landstra CP, Ruissen MM, Regeer H, Nijhoff MF, Ballieux BEPB, van der Boog PJM, de Vries APJ, Huisman SD, de Koning EJP. Impact of a Public Health Emergency on Behavior, Stress, Anxiety and Glycemic Control in Patients With Pancreas or Islet Transplantation for Type 1 Diabetes. Transpl Int. 2024 Mar 27;37:12278. doi: 10.3389/ti.2024.12278. eCollection 2024.

    PMID: 38601276DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2COVID-19Social Isolation

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Eelco JP de Koning, MD PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor in Diabetology

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 4, 2023

Study Start

May 2, 2020

Primary Completion

July 10, 2020

Study Completion

July 10, 2020

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations

NL(1)