Satisfaction, Efficiency, Cost-Effectiveness, target group analysis, Register Free Style Libre|
|- candidate number||25635|
|- NTR Number||NTR6212|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-dec-2016|
|- Secondary IDs||16.0346 METC|
|- Public Title||Satisfaction, Efficiency, Cost-Effectiveness, target group analysis, Register Free Style Libre|
|- Scientific Title||Satisfaction, Efficiency, Cost-Effectiveness and target group analysis in the use of the Free Style Libre glucose registration|
|- Healt Condition(s) or Problem(s) studied||Satisfaction, Efficacy, Cost-effectiveness |
|- Inclusion criteria||1. All are treated by or have a referral to a second-line diabetes team.|
2. In 2015 already insured with Zilveren Kruis.
3. Belonging to one or more of the target groups (see below)
4. Mandatory participation in the follow-up study.
- "Hypoglycemia unawareness' and despite an average of > 6 glucose measurements per day over the past year and intensive support from the diabetes team still suffer from hypoglycemia.
- Unexpected hypoglycemia’s despite an average of > 6 measurements per day over the past year and intensive support from the diabetes team.
- Insulin-dependent diabetics who do not come despite maximum efforts by the insured (frequent blood monitoring and proper lifestyle management) and intensive supervision of the healthcare team to improve their glycemic control, as evidenced by a mean HbA1c > 70 mmol / mol (8.5%) in the past year.
- A job, which sensation loss of fingers finger prick can cause disability, such as musicians, and on the advice of the healthcare team having more than 6 measurements per day.
- A job, where relatively rarely occurring hypoglycemia wil mean a danger to themselves and / or others and may lead to disability or of safety risks
- Patients who qualify for continuous glucose registration (CGM)
|- Exclusion criteria||- Children < 18 year|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-jul-2016|
|- planned closingdate||15-jul-2019|
|- Target number of participants||1000|
|- Interventions||Observational study of the use of the Free Style Libre Flash Monitor in daily practibe|
|- Primary outcome||Quality of life,|
- frequency of hypoglycaemia incidents (in grades 1-3)
- Number of hospitalizations related to DM
|- Secondary outcome||- Changes in HbA1c|
- amount of labors day loss / illness days
- Degree of change in functioning (including sports performance)
Separate secondary outcome:
Cost-effectiveness and cost-benefit analysis (optional, if linking is allowed files over a TTP
|- Timepoints||analysis of baseline information, longitudinally at 6 months and one year.|
cost effectiveness analysis after closure of the study.
|- Trial web site||www.fslregister.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. H.J.G. Bilo|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.J.G. Bilo|
|- Sponsor/Initiator ||Isala Zwolle|
(Source(s) of Monetary or Material Support)
|Stichting Achmea Gezondheidszorg (SAG)|
|- Brief summary||Diabetes mellitus is a common condition in the Netherlands with a prevalence of more than 830,000 people in 2011, based on the basic general practitioner registration. It is expected that the prevalence of diabetes will increase over 30% in 2030.|
A part of the people with diabetes check their blood glucose levels frequently. In which determination of the capillary blood, by means of a finger prick, is a widely used method. Patients with difficulties in controlling diabetes, i.e. with frequent hypoglycaemia, will therefore measure their glucose levels several times a day. This frequency can sometimes rise to more than six times a day (with peaks up to 15 times per day), which has a clear impact on quality of life.
In the past few years it has become possible to measure glucose levels continuously, by means of continuous glucose registration (Continuous Glucose Monitoring, CGM). With this method, assessing glucose levels at short intervals (a few minutes), a continuous registration can be obtained with regards to the glucose concentrations in the interstitial fluid. For this purpose a probe is placed under the skin, which measures the glucose concentrations. The measured values can be displayed on a display.
The equipment as described above is expensive and is currently still being applied relatively rare, at least in the Netherlands. It is also known that the glucose levels measured in the interstitial fluid are lower than in the bloodstream itself, and that changes in interstitial blood glucose concentrations lag somewhat behind in comparison with capillary measurements. Therefore the CGMs are working with algorithms to adjust for such lag time differences.
In addition, the values measured in the interstitial fluid appear to be less accurate when the glucose levels are changing rapidly in the bloodstream, for example after a meal. In the somewhat longer in-use devices, it is therefore necessary to calibrate the meter two to four times per day in a stable situation after the measuring capillary glucose value, and to bring this data into the CGM equipment to allow calibration.
In 2014, Abbott presented the FreeStyle Libre (FSL device and sensor), which also allows a more or less continuous glucose registration. For this purpose a sensor is provided subcutaneously, performing frequent measurements. The sensor can be left in the skin for fourteen days. The data obtained are not automatically presented, as is the case in previous CGM devices. At the FSL device, the values can only be read when the FSL device is read out by a hand-held scanner. Through this technique, the glucose levels of the last eight hours can be displayed. The FSL sensor is already calibrated in the factory so it is not necessary (but also not possible) to calibrate this sensor after insertion. This information should also be stated expressly by the manufacturer; furthermore the only place where the sensor is allowed to be mounted / inserted is the upper arm.
Up to recently, the measurement method of the FSL was not adequately validated, since there were virtually no good independently comparative studies between this new method and a method that corresponds to the golden standard or the gold standard itself. Many of the studies performed by or with sponsorship by Abbott compared the FSL-CGM measurements with capillary measurements. When comparing these methods, one should realize that capillary measurements can deviate by up to 15% of the glucose gold standard. In theory the FSL can deviate another 15% of these standard, decreasing to 10% after the first day. This indicates that the differences between the glucose golden standard and the FSL may be substantial. Even now, some recent studies with more data submitted by Abbott, still can be said that there are uncertainties regarding the reliability and bias of the FSL. Therefore, accuracy of the FSL CGM should be considered to be moderate.
In spite of the restrictions which have been mentioned , the FSL is found to be a positive asset to be used by patients with various challenges when trying to reach a more stable glucose control with less periods of hypoglycemia. There have been patients who have purchased the product at their own expense and they have used it to complete satisfaction. It will also be a solution for patients who do not achieve good glycemic control despite frequent finger pricks. Reduction of fear and insecurity are important aspects in this matter.
At the moment one health insurance company is interested in arranging a contribution for its clients towards the costs of the FSL, although this is not possible in the context of the Health Insurance Act. Currently, the proposal is to reimburse part of the expenses for the device, on the provision that more research will be performed. Therefore a better understanding will be obtained in the indication areas and target groups.
|- Main changes (audit trail)||29-apr-2017-EB|
HbA1c from secondary outcome to primary outcome
|- RECORD||6-dec-2016 - 29-apr-2017|
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