Lipohypertrophy Monitoring Study

NCT04659330 | Completed

• 1 other identifier: 17/41/458
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Lipohypertrophy; Hypoglycemia

Keywords

lipohypertrophy; online education; insulin injection technique; diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Insulin dose in patients with and without lipohypertrophy

  6 months

Study Arms (1)

Intervention group

OTHER

All patients underwent intervention

Behavioral: Online education (BdandMe) for injection technique; Device: 4mm needles

Interventions

Online education (BdandMe) for injection technique BEHAVIORAL

patients were referred to the relevant modules on BD and Me™ (for online education)

Intervention group

4mm needles DEVICE

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (6)

• 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.

  PMID: 27594187 BACKGROUND

• 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.

  PMID: 29159095 BACKGROUND

• 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.

  PMID: 27594186 BACKGROUND

• 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.

  PMID: 23886784 BACKGROUND

• 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.

  PMID: 28099050 BACKGROUND

• 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.

  PMID: 34407260 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Interventions

Needles

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 9, 2020
• Study Start: June 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: December 24, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)