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Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care

NCT02271594 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-06-09

Study results available
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Summary

The investigators intend to assess the impact of optimized injection technique on the evolution of clinical parameters in insulin-treated patients with diabetes (DM) who have clinical lipohypertrophy (LH) in a controlled, prospective study with a follow-up of 6 months, conducted at Ealing Hospital, West London, UK. DM patients who have LH and inject into it will be randomized to either switch to normal tissue sites with intensive education as to why and how and use of a 4mm pen needle, or to continue with standard care. The endpoints measured will include the impact on glucose control parameters, consumption of insulin, hypoglycaemia rates, use of health services resources and health care costs

Conditions

  • Insulin Injections and Lipohypertrophy

Interventions

BEHAVIORAL

Intensive Training on Best Insulin Injection Technique

The intervention consists of instructing patients in whom LH is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.

BEHAVIORAL

Standard education on injection technique

Usual and customary education and training normally provided injecting patients at the center

Sponsors & Collaborators

  • Ealing Hospital NHS Trust

    collaborator OTHER

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Grace E Vanterpool, RN · Ealing Hospital, Northwest London NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

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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 NCT02271594 on ClinicalTrials.gov