For this study, we will: - Quantify health literacy and numeracy in people with type 1 or type 2 diabetes on intensive insulin therapy (Multiple daily injections of insulin (MDI), or continuous subcutaneous insulin infusion (CSII)) - Examine the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is health literacy assessed using the health literacy
questionnaire (HLQ).
Secondary outcome
Secondary endpoints are numeracy skills assessed by the short version of the
diabetes numeracy test (DNT-15), individuals* readiness for usage of digital
health services or technology assessed by the Readiness and enablement index
for Health technology (RAEADHY), healthy behaviour (dietary pattern assessed
through the goFOODTMLite system and Maastricht Food Frequency Questionnaire,
and physical activity assessed with the ac-tivPal4TM), and patient reported
outcomes (e.g., diabetes treatment satisfaction questionnaire, problem areas in
diabetes distress, etc.). Glycaemic outcomes are assessed as haemoglobin A1c
and blinded FreeStyle Libre 3 continuous glucose monitoring (CGM) according to
inter-national consensus for CGM outcomes for outpatients.
Background summary
Despite recent advances in diabetes therapy and the availability of innovative
diabetes tools, achieving optimal glycaemic remains an ongoing challenge for
the majority of people with diabetes, particularly those requiring insulin
treatment. Given the complexity of such treatment, the role of health literacy
has gained attention as a crucial factor in optimizing diabetes care. Essential
skills for diabetes self-management include estimating the carbohydrate content
of a meal and adjusting insulin doses. The efforts needed for such self-care
are considered complex, time demanding and therefore error-prone. Sparse
information exists regarding health literacy skills within the general European
diabetes population.
Study objective
For this study, we will:
- Quantify health literacy and numeracy in people with type 1 or type 2
diabetes on intensive insulin therapy (Multiple daily injections of insulin
(MDI), or continuous subcutaneous insulin infusion (CSII))
- Examine the relationship between health literacy and numeracy with glycaemic
control, health behaviours and patient-reported outcomes.
Study design
This multicentre cross-sectional study will recruit 209 people with type 1 or
type 2 on insulin therapy in four outpatient clinics across Europe. Health
literacy and numeracy will be assessed with the Health Literacy Questionnaire
and the short version of the Diabetes Numeracy Test. Glycaemic control will be
assessed through a blinded CGM and standard routine HbA1c measurements.
Participants will wear an activPAL4TM to monitor physical activity, and record
their dietary pattern using the goFOODTMLite for fourteen consecutive days.
Quality of life, diabetes distress, diabetes treatment satisfaction and
awareness of hypoglycaemia are also assessed. Multiple linear regression models
will be applied to identify factors that are independently associated with
health literacy.
Study burden and risks
The study participants will not benefit directly from participating in this
cross-sectional study; however, they can gain valuable insights into their
numeracy and health literacy skills. Over-all, the risks and burdens associated
with this trial can be considered negligible and the burden can be considered
minimal. Potentially, some participants may experience skin irritations,
itchiness, or discomfort due to the adhesives of the FreeStyle Libre 3 CGM
which are typically self-limiting and short in duration, and with no long-term
sequelae.
Universiteitssingel 50
Maastricht 6200MD
NL
Universiteitssingel 50
Maastricht 6200MD
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a participant must meet all of the
following criteria:
- Time from diagnosis of type 1 (inclusief LADA) or 2 diabetes mellitus >=1
year
- Age between 18 to 80 years including both age limits
- On intensive insulin treatment >= 1 year
- Willing and able to use the goFOODTMLite, activPAL4TM and the blinded CGM,
and to complete all questionnaires.
- Ability to provide informed consent
Exclusion criteria
- Inability to understand the local language of the country where the study is
conducted (at the investigator*s discretion).
- Other subtypes of diabetes than type 1 or type 2 diabetes (e.g., gestational
diabetes, MODY)
- Severe cognitive, hearing or visual impairment preventing participants in
completing the questionnaires and/or using the trial devices at the
investigator*s discretion
- Known hypersensitivity to the CGM sensor band-aid
- Current or recent participation (within the last three months) in clinical
trials/research projects (at the investigator*s discretion)
- Unstable cardiovascular disease (major adverse cardiovascular event in the
last 6 months), active malignancy (chemotherapy or palliation therapy in the
last 6 months), kidney failure (eGFR < 30 mL/min/1.73 m2), and/or dialysis at
the investigator*s discretion.
- Severe medical or psychological conditions preventing participants from
completing the questionnaires and/or using the trial devices (at the
investigator's discretion)
- Current pregnancy or breastfeeding or planning on pregnancy for the duration
of the trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86402.068.24 |