Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
171 participants
INTERVENTIONAL
2018-06-01
2019-12-24
Brief Summary
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Detailed Description
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Secondary objective
To assess the impact of the intervention on other parameters of glucose control (including HbA1c, unexplained hypoglycaemia and glycaemic variability). To calculate direct and indirect savings associated with better glucose control.
Tertiary objective
To assess the impact of the intervention (especially eLearning) on patients' injection technique self-care knowledge and behaviors, including correct site rotation, non-injection into lipohypertrophy and needle reuse patterns. To calculate direct and indirect savings associated with better educational approaches and behavioral changes.
Audit Targets and Standards The sample size targeted will be 190 completed patient records. Each center will be asked to contribute between 20-50 subjects. Optimal injection technique and optimal needle length selection are based on Belgian guidelines on Injection, which are based on recently published FITTER worldwide recommendations. A study day will be held for participant nurses to review the protocol and audit forms, and for refresher training in lipohypertrophy detection.
Endpoints Total Daily Dose (TDD) of insulin HbA1c (as mmol/mol) Unexplained hypoglycaemic episodes (defined in Entry/Exit Forms) Severe hypoglycaemia (requiring the intervention of a third party) Glycaemic variability (defined in Entry/Exit Forms) Rotation of injection sites with spacing apart of punctures by at least 1 cm Reuse of needles
Presence of lipohypertrophy Injections into lipohypertrophic lesions Injection technique practices Adherence to proposed best practice intervention recommendations Data with cost implications (resource usage, hypoglycaemic events) Self-care injection technique knowledge and behaviours Qualitative and quantitative BD and MeTM patient user experience Clinician education, training and information inputs required support behaviour modification and adherence to treatment Quality of Life assessment Unplanned Interventions: ER, Ambulance, Hospital Admission, Critical Cared admission
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intervention group
All patients underwent intervention
Online education (BdandMe) for injection technique
patients were referred to the relevant modules on BD and Me™ (for online education)
4mm needles
Providing a supply of needles for single use of 4mm insulin injection needle.
Interventions
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Online education (BdandMe) for injection technique
patients were referred to the relevant modules on BD and Me™ (for online education)
4mm needles
Providing a supply of needles for single use of 4mm insulin injection needle.
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes Mellitus
* Age 18 or above
* Injecting insulin for at least 1 year
* Self-managing injection therapy, including daily glucose monitoring
* Access to a device with internet
* Confident in navigating the internet
Exclusion Criteria
* Pregnant or likely to become pregnant during study period
* Impaired cognitive ability which would prevent informed consent
* Syringe only user
* Insulin pump user
* GLP-1 RA therapy only
* Patients declining to take part in the study
* Cannot read and understand Dutch
* No access to an internet enabled device
18 Years
ALL
No
Sponsors
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Becton, Dickinson and Company
INDUSTRY
University Hospital, Antwerp
OTHER
Responsible Party
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Christophe De Block
Professor
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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References
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Frid AH, Kreugel G, Grassi G, Halimi S, Hicks D, Hirsch LJ, Smith MJ, Wellhoener R, Bode BW, Hirsch IB, Kalra S, Ji L, Strauss KW. New Insulin Delivery Recommendations. Mayo Clin Proc. 2016 Sep;91(9):1231-55. doi: 10.1016/j.mayocp.2016.06.010.
Grassi G, Scuntero P, Trepiccioni R, Marubbi F, Strauss K. Optimizing insulin injection technique and its effect on blood glucose control. J Clin Transl Endocrinol. 2014 Jul 23;1(4):145-150. doi: 10.1016/j.jcte.2014.07.006. eCollection 2014 Dec.
Frid AH, Hirsch LJ, Menchior AR, Morel DR, Strauss KW. Worldwide Injection Technique Questionnaire Study: Injecting Complications and the Role of the Professional. Mayo Clin Proc. 2016 Sep;91(9):1224-30. doi: 10.1016/j.mayocp.2016.06.012.
Blanco M, Hernandez MT, Strauss KW, Amaya M. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab. 2013 Oct;39(5):445-53. doi: 10.1016/j.diabet.2013.05.006. Epub 2013 Jul 22.
Ji L, Sun Z, Li Q, Qin G, Wei Z, Liu J, Chandran AB, Hirsch LJ. Lipohypertrophy in China: Prevalence, Risk Factors, Insulin Consumption, and Clinical Impact. Diabetes Technol Ther. 2017 Jan;19(1):61-67. doi: 10.1089/dia.2016.0334.
Bochanen N, Decochez K, Heleu E, Cuypers J, Vercammen C, Coremans P, Vanhaverbeke G, Shadid S, Keymeulen B, Bolsens N, De Block C. Lipohypertrophy Monitoring Study (LIMO): Effect of single use of 4 mm pen needles combined with education on injection site rotation on glycaemic control: Confirmation of an unpleasant truth. Diabet Med. 2022 Jan;39(1):e14672. doi: 10.1111/dme.14672. Epub 2021 Sep 29.
Other Identifiers
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17/41/458
Identifier Type: -
Identifier Source: org_study_id