No registrations found.
ID
Source
Health condition
Diabetes Mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in HbA1c in mmol / mol. The intervention is considered effective with a decrease in HbA1c of 10% or more (5.39 mmol / mol).
Secondary outcome
•% of patients who reach the target value (≤ 53 mmol / mol or ≤ 58 mmol / mol, depending on age, duration of illness and medication)
•% of patients going from orange (75 mmol / mol) to green (53 mmol / mol)
•% of patients going from red (91 mmol / mol) to green (53 mmol / mol)
• Experiences of patients with the POCT of HbA1c
• Change in well-being
• Change in weight
Background summary
Rationale:
The risk of microvascular and macrovascular complications in people with diabetes increases as the HbA1c value in the blood increases. Previous studies have shown that exercise has a positive influence on HbA1c in people with diabetes. Never before has repeated research been conducted into the effects of an intensive period of (organised) walking on blood HbA1c levels in the Dutch population of diabetes patients.
Aim:
The primary aim of the study is to increase knowledge about the short and medium term effect of an intensive period of (organised) exercise on the level of HbA1c in the blood of diabetics. This can help caregivers in giving lifestyle advice to people with diabetes. Secondary objective is insight into experiences with a scientifically proven, accurate and reliable, but hardly used point-of-care testing method for determining the HbA1c content with blood from a finger prick. The results from this study can be used by GPs when choosing whether to use the new measurement method in their practices.
Research design:
Cohort study.
Research population:
Adult patients (18 years or older) with diabetes mellitus (types 1 and 2) participating in the National Diabetes Challenge (20 weeks of organised walking).
Measurements:
- POCT measurement of HbA1c during last day of the National Diabetes Challenge, after 3 months and after 6 months
- Baseline value of HbA1c retrieved retrospectively at central laboratory
- Patient questionnaires during last week of National Diabetes Challenge, after 3 months and after 6 months
Study objective
A decrease in HbA1c directly after the National Diabetes Challenge compared to baseline.
Study design
Baseline, last day of National Diabetes Challenge, 3 months, 6 months
Intervention
None, participants walk organised as part of the National Diabetes Challenge
Inclusion criteria
• Adult patient (18 years or older).
• Diagnosed with Type 1 or 2 Diabetes Mellitus.
• Participant in the National Diabetes Challenge.
• Registered with one of the GP practices in the star-shl diagnostic center regions (Rotterdam region, Etten-Leur region).
Exclusion criteria
No informed consent
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7818 |
| Other | CMO region Arnhem Nijmegen : ABR70687 |