Type 1 DiabetesNCT05977205
COVID-19 Glycemic Control Study
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Leiden University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- How many people
- 492 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 May 2020to 10 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Official title: 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.
Read more
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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- No interventions, observational study
- Keywords
- COVID-19 Pandemic, Type 1 Diabetes, Type 2 Diabetes, Beta Cell Transplantation, Social isolation, Glycemic control, Distress, COVID-19 Lockdown
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, COVID-19, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions, observational studyOther
Not applicable, no interventions, observational study
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | 280 patients with type 1 diabetes Receives: Other: No interventions, observational study | |
| Type 2 Diabetes | 155 patients with type 2 diabetes Receives: 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 Receives: Other: No interventions, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
HbA1c (mmol/mol Hb)
Measured: 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
Continuous Glucose Measurement parameters (time in range, time above range, time below range)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start2 May 2020
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eelco JP de Koning, Leiden University Medical Center
- Investigators
- Eelco JP de Koning, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977205
- Sponsor's protocol ID
- NL73778.058.20
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38601276
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Self-quarantining on Glycemic Control, Diabetes Self-management and Distress During the Coronavirus Outbreak
- ClinicalTrials.gov ID
- NCT05977205
- Acronym / sponsor ID
- NL73778.058.20
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | Other: No interventions, observational study280 patients with type 1 diabetes |
| Type 2 Diabetes | – | Other: No interventions, observational study155 patients with type 2 diabetes |
| Type 1 Diabetes with Islet or Pancreas Transplantation | – | Other: No interventions, observational study23 patients with islet transplantation, 7 with pancreas transplantation, 27 with simultaneous pancreas-kidney transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions, observational studyNot applicable, no interventions, observational study | Other | Type 1 Diabetes, Type 1 Diabetes with Islet or Pancreas Transplantation, Type 2 Diabetes |
Primary outcome
Glycemic control
Time frame: 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)
HbA1c (mmol/mol Hb)
8 secondary outcomes
Glycemic control
Time frame: 2 week period during lockdown compared to 2 week period before lockdown
Stress
Time frame: 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
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Weight
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Physical activity
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Glycemic control and insulin requirements
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Social isolation behaviour
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Fear of COVID-19 infection
Time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 38601276Landstra 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eelco JP de Koning, MD PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05977205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.