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

NCT ID: NCT05407233

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2022-10-10

Brief Summary

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.

Detailed 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group 1

Doesn´t reuse the syringe for insulin application

Group Type: ACTIVE_COMPARATOR

Does not reuse the syringe for insulin application

Intervention Type: DEVICE

Does not reuse needles for insulin application Patients will be given quantity of needles for use during the study period according to the allocated group and a collector for sharps descarpack to collect the used syringes and needles. Initially, all patients will be instructed on the indication and importance of insulin use, aspects of conservation, preparation and administration, reviewing the dose aspirated in the syringe. They will also be instructed in relation to the use of the collector for sharps. Patients will also receive the booklet specially designed for this registry where they must indicate the number of hematomas, bruises, lipodystrophies, or inflammation that they identify whenever they occur. This booklet will be given to the team of researchers at each visit (monthly), who will review the records with the patient and guide them for subsequent completion.

Group 2

Uses the syringe five times to insulin application

Group Type: EXPERIMENTAL

Uses the syringe for insulin delivery five times

Intervention Type: DEVICE

Uses the needles for insulin application five times. Patients will be given quantity of needles for use during the study period according to the allocated group and a collector for sharps descarpack to collect the used syringes and needles. Initially, all patients will be instructed on the indication and importance of insulin use, aspects of conservation, preparation and administration, reviewing the dose aspirated in the syringe. They will also be instructed in relation to the use of the collector for sharps. Patients will also receive the booklet specially designed for this registry where they must indicate the number of hematomas, lipodystrophies, or inflammation that they identify whenever they occur. This booklet will be given to the team of researchers at each visit (monthly), and they will review the records with the patient and guide them for subsequent completion.

Interventions

Does not reuse the syringe for insulin application

Does not reuse needles for insulin application Patients will be given quantity of needles for use during the study period according to the allocated group and a collector for sharps descarpack to collect the used syringes and needles. Initially, all patients will be instructed on the indication and importance of insulin use, aspects of conservation, preparation and administration, reviewing the dose aspirated in the syringe. They will also be instructed in relation to the use of the collector for sharps. Patients will also receive the booklet specially designed for this registry where they must indicate the number of hematomas, bruises, lipodystrophies, or inflammation that they identify whenever they occur. This booklet will be given to the team of researchers at each visit (monthly), who will review the records with the patient and guide them for subsequent completion.

Intervention Type: DEVICE

Uses the syringe for insulin delivery five times

Uses the needles for insulin application five times. Patients will be given quantity of needles for use during the study period according to the allocated group and a collector for sharps descarpack to collect the used syringes and needles. Initially, all patients will be instructed on the indication and importance of insulin use, aspects of conservation, preparation and administration, reviewing the dose aspirated in the syringe. They will also be instructed in relation to the use of the collector for sharps. Patients will also receive the booklet specially designed for this registry where they must indicate the number of hematomas, lipodystrophies, or inflammation that they identify whenever they occur. This booklet will be given to the team of researchers at each visit (monthly), and they will review the records with the patient and guide them for subsequent completion.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz D Agord Schaan, PhD

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Locations

Gabriela Berlanda

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

2018-0574

Identifier Type: -

Identifier Source: org_study_id