Lipohypertrophy Monitoring Study (LiMo)

• ClinicalTrials.gov Identifier: NCT04659330
• Recruitment Status: Completed
• First Posted: December 9, 2020
• Last Update Posted: December 9, 2020
• Sponsor: University Hospital, Antwerp
• Collaborator: Becton, Dickinson and Company
• Information provided by (Responsible Party): Christophe De Block, University Hospital, Antwerp

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Lipohypertrophy; Hypoglycemia	Behavioral: Online education (BdandMe) for injection technique; Device: 4mm needles	Not Applicable

Detailed 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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 171 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Lipohypertrophy Monitoring Study
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: December 24, 2019

Arms and Interventions

Arm	Intervention/treatment
Intervention group; All patients underwent 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.

Outcome Measures

Primary Outcome Measures :

1. HbA1c [ Time Frame: 6 months ]
   Primary outcome parameter was the evolution between baseline and end-of-study percentage of needle reuse and injecting in a zone of lipohypertrophy.
2. Severe and unexplained hypoglycemia [ Time Frame: 6 months ]

   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.

3. glucose variability [ Time Frame: 6 months ]

   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).

Secondary Outcome Measures :

1. Insulin dose in patients with and without lipohypertrophy [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Belgium

Antwerp University Hospital

Edegem, Antwerp, Belgium, 2650

Sponsors and Collaborators

University Hospital, Antwerp

Becton, Dickinson and Company

More Information

Publications:

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.

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. Review.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Christophe De Block, Professor, University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT04659330
• Other Study ID Numbers: 17/41/458
• First Posted: December 9, 2020
• Last Update Posted: December 9, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Christophe De Block, University Hospital, Antwerp:

lipohypertrophy; online education; insulin injection technique; diabetes mellitus

Additional relevant MeSH terms:

Diabetes Mellitus; Hypoglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases