Lipohypertrophy Monitoring Study

Diabetes Mellitus Clinical Trial

— LiMo  

Official title:

Lipohypertrophy Monitoring Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659330
• Other study ID #: 17/41/458
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 24, 2019

Study information

• Verified date: December 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators intend to audit the impact of optimal injection technique education delivered through a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform on clinical parameters and self-care behaviours of insulin treated patients in a prospective audit with follow-up in 6 months, conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points measured will include the impact on consumption of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.

Description:

Principle objective To assess the impact of optimal injection technique education, tailored learning prescription and use of BD Micro-FineTM Ultra 4mm x 32G pen needle upon total daily dose of insulin consumption in patients with or without clinically detectable lipohypertrophy. To assess the cost of intervention vs. direct savings with a view to use of the data in needle reimbursement discussions with the Belgian health care authorities.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 24, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria

• Type 1 Diabetes Mellitus

• 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

Patient Exclusion Criteria

• Children <18 years

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypoglycemia
• Lipohypertrophy

Intervention

Behavioral:
• Online education (BdandMe) for injection technique
patients were referred to the relevant modules on BD and Me™ (for online education)

Device:
• 4mm needles
Providing a supply of needles for single use of 4mm insulin injection needle.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Becton, Dickinson and Company

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

Blanco M, Hernández 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Primary outcome parameter was the evolution between baseline and end-of-study percentage of needle reuse and injecting in a zone of lipohypertrophy.	6 months
Primary	Severe and unexplained hypoglycemia	Primary outcome parameter was the evolution between baseline and end-of-study percentage of needle reuse and injecting in a zone of lipohypertrophy.; Hypoglycemia is defined as the occurrence of = 1 symptom and a confirmed glucose reading =60 mg/dl. Unexplained hypoglycemia is defined as hypoglycemia occurring in the absence of a definable precipitating event such as a change in medication, diet or activity.	6 months
Primary	glucose variability	Primary outcome parameter was the evolution between baseline and end-of-study percentage of needle reuse and injecting in a zone of lipohypertrophy.; Increased glucose variability was defined as the occurrence of at least 3 times a week glucose values evolving from <60 mg/dl (3.3 mmol/l) to >250 mg/dl (13.9 mmol/l) or vice versa (i.e. a delta >190 mg/dl or 10.6 mmol/l).	6 months
Secondary	Insulin dose in patients with and without lipohypertrophy	Secondary objectives were to evaluate the impact of the use of 4mm pen needles and an educational platform focused on correct injection technique, correct rotation of injection sites, non-injection into lipohypertrophy sites and stopping needle reuse on the insulin dose in patients with and without lipohypertrophy.	6 months