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Lipohypertrophy Monitoring Study

NCT04659330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2020-12-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    collaborator INDUSTRY

  • University Hospital, Antwerp

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-05-31
Completion
2019-12-24

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659330 on ClinicalTrials.gov