Clinical trial NCT05407233: Reusing Needles for Subcutaneous Insulin Injection in Patients With Type 2 Diabetes
Official title: Interdisciplinary Care for the Patient With Type 2 Diabetes: Promoting Improvement in the Quality of Care at an Outpatient Level and Seeking Answers to Clinical Practice Questions - Reuse of Inputs and Placebo Intervention Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Reuse needle
Insulin administration
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial will be carried out to compare the reuse or not of needles in diabetes patients who use insulin. The groups will be divided in two: a group that will not reuse the needles and a group that will reuse the needles five times. 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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in glycemic control
timeFrame: Baseline and Month 3
measure: Change in Skin complications
timeFrame: Baseline, Month1, Month 2 and Month 3
measure: Change in Pain assessment
timeFrame: Baseline, Month1, Month 2 and Month 3
Secondary outcomes:
measure: Evaluate the quality of needles after reuse of the insulin administration needle compared to non-reuse.
timeFrame: Month 2
measure: Evaluate the microbiological contamination after reuse of the insulin administration needle compared to non-reuse.
timeFrame: Month 2
measure: Insulin Injection technique
timeFrame: Baseline and Month 3
measure: Adherence to diabetes treatment
timeFrame: Baseline, Month1, Month 2 and Month 3
measure: Quality of life assessment
timeFrame: Baseline, Month1, Month 2 and Month 3
measure: Frequency of capillary blood glucose tests
timeFrame: Baseline
measure: Frequency of reuse of lancets of included patients
timeFrame: Baseline
measure: Analyze cost-utility
timeFrame: Baseline, Month1, Month 2 and Month 3
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Gabriela Berlanda
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Beatriz D Agord Schaan, PhD
role: STUDY_DIRECTOR
References: