Reusing Needles for Subcutaneous Insulin Injection in Patients With Type 2 Diabetes

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Does not reuse the syringe for insulin application; Device: Uses the syringe for insulin delivery five times

Study type: Interventional

Funder types: Other

Identifiers

NCT05407233

2018-0574

Details and patient eligibility

About

A randomized clinical trial (RCT) will be carried out to compare the reuse or not of needles in patients with type 2 diabetes (T2DM) that use insulin. Two groups will be studied: a group that will not reuse the needles and a group that will reuse the needles five times. The aim of this study is to evaluate related outcomes such as bruises, infection, lipodystrophy, pain and glycemic control, whether or not to reuse insulin delivery needles in patients with T2DM who use insulin.

Full description

Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease with increasing incidence worldwide. It is well demonstrated in the literature that adequate glycemic control can reduce the incidence of chronic complications. The Brazilian Ministry of Health must provide patients with diabetes with the necessary resources for optimal glycemic control. However, this supply is often not enough and the population ends up reusing needles and lancets. According to the Brazilian National Health Surveillance Agency (ANVISA) and the manufacturers, it is recommended to use the needle for insulin application only once, but a report from the Brazilian Society of Diabetes shows that half of the patients disregard this rule - some reuse each needle up to five times. Studies show that patients do not like carrying extra needles when they are away from home, are reluctant to carry containers to dispose used needles, and decide that it is not worthwhile worth buying a new needle for each injection. Others describe that injections from reused needles are not noticeably more painful as long as they do not reuse them excessively. Finally, some patients believe that disposing of a needle after use is ecologically wasteful because metal and plastic must be incinerated. A randomized clinical trial will be carried out to compare the reuse or not of needles in patients with diabetes who use insulin. Primary outcomes as skin complications, local pain, glycemic control will be evaluated at baseline and after 4, 8 and 12 weeks and secondary outcomes will also be evaluated as quality of life, insulin application technique, frequency of capillary blood glucose tests, adherence to treatment, quality of needles, microbiological contamination and cost-utility analysis of after needle reuse.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with T2DM
• Over 18 years of age
• Reuses each syringe at least three times for insulin application.

Exclusion criteria

• Use of insulin pens
• Pregnant women
• Patients undergoing chemotherapy
• Use of anticoagulants
• Clotting disorders, lesions or skin changes

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Doesn´t reuse the syringe for insulin application

Treatment:

Device: Does not reuse the syringe for insulin application

Group 2

Experimental group

Description:

Uses the syringe five times to insulin application

Treatment:

Device: Uses the syringe for insulin delivery five times