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Satisfaction, Efficiency, Cost-Effectiveness, target group analysis, Register Free Style Libre

Satisfaction, Efficiency, Cost-Effectiveness and target group analysis in the use of the Free Style Libre glucose registration

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27606
Enrollment
1000
Registered
2016-12-06
Start date
2016-07-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Satisfaction, Efficiency, Cost-Effectiveness, target group analysis, Register Free Style Libre Tevredenheid, effectiviteit, kosten-effectiviteit en doelgroep analyses, Register Free Style Libre

Interventions

Observational study of the use of the Free Style Libre Flash Monitor in daily practibe

Sponsors

M.J. Fokkert m.j.fokkert@isala.nl
Lead Sponsor

Eligibility

Inclusion criteria

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. target groups: - "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

Exclusion criteria: - Children < 18 year

Design outcomes

Primary

MeasureTime frame
- Quality of life - frequency of hypoglycaemia incidents (in grades 1-3) - Number of hospitalizations related to DM - Changes in HbA1c

Secondary

MeasureTime frame
- 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

Contacts

Public ContactH.J.G. Bilo

internist Universitair Medisch Centrum Groningen Hanzeplein 1, 9713 GZ Groningen Afdeling Interne Geneeskunde Hoofd Diabetes Kenniscentrum Zwolle Postbus 10400, 8000 GK Dokter van Heesweg 2, 8025 AB Zwolle

h.j.g.bilo@isala.nl038-4242518

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)