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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Does not reuse the syringe for insulin application
* Device: Uses the syringe for insulin delivery five times


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Doesn´t reuse the syringe for insulin application | Device: Does not reuse the syringe for insulin application<br>* 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.<br>|
| Experimental: Group 2<br>Uses the syringe five times to insulin application | Device: Uses the syringe for insulin delivery five times<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control | For assessment of glycemic control, HbA1c will be requested if the patient has not performed the test in the last month at the initial meeting and at the end of the study, after 12 weeks, for all patients. | Baseline and Month 3 | 
| Change in Skin complications | Dermatological conditions will be evaluated for the formation of hematomas, ecchymoses, appearance of lipodystrophy (lipohypertrophy and lipoatrophy), signs of inflammation and pain in the applications. In the follow-up meetings, the skin complications presented by the patient at the insulin injection sites will be recorded through photography by the professional. To aid in the evaluation of skin complications, a partnership will be established carried out with the TeleHealth Program, where distance and standard pixel size will be used for photos of patients' skin complications through a professional digital camera. | Baseline, Month1, Month 2 and Month 3 | 
| Change in Pain assessment | The evaluation of pain in the application of insulin will be evaluated through a one-dimensional numerical scale of pain intensity, according to the clinical record in the follow-up meetings which consists of numbers from 0 to 10 (0 =  no pain to 10= worst pain imaginable). | Baseline, Month1, Month 2 and Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the quality of needles after reuse of the insulin administration needle compared to non-reuse. | Needle quality evaluation will be performed through the penetration test and drag through using the Mecmesin digital dynamometer (Advanced Force Gauge). | Month 2 | 
| Evaluate the microbiological contamination after reuse of the insulin administration needle compared to non-reuse. | To evaluate the microbiological contamination of the needles, the semi-quantitative culture method of the external surface of the needle will be carried out (Maki's method). | Month 2 | 
| Insulin Injection technique | The iInsulin Injection technique will be evaluated through the Insulin Injection Technique Questionnaire (ITQ) which consists of an initial session with the patient, followed by observation of the injection technique and examination of the injection sites by the researcher. | Baseline and Month 3 | 
| Adherence to diabetes treatment | Adherence to treatment will be verified using the SCI-R questionnaire (Self Care Inventory- Revised Version), validated for Portuguese. Is a 15-item questionnaire, on a 5-point Likert scale that reflects how well the subjects followed recommendations for self-care during the past month (1 = never to 5 = always). | Baseline, Month1, Month 2 and Month 3 | 
| Quality of life assessment | The quality of life with a focus on insulin application will be evaluated through the DQOL-Brazil questionnaire (Diabetes Quality Of Life Measure). DQOL consists of 4 domains (satisfaction, impact, social/vocational worries, and diabetes-related worries) whose answers are scored from 1 to 5. Lower scores indicate higher quality of life. The social/vocational worries domain was excluded because most of our participants were retired or inactive. | Baseline, Month1, Month 2 and Month 3 | 
| Frequency of capillary blood glucose tests | Information related to capillary blood glucose monitoring of included patients and other information such as ways of acquiring supplies. | Baseline | 
| Frequency of reuse of lancets of included patients | Information related to capillary blood glucose monitoring of included patients and other information such reuse of lancets will be evaluated by completing a form at the initial meeting. | Baseline | 
| Analyze cost-utility | Costs will be estimated from several standard cost lists. The survey of costs will be based on the values of sale sold in the Brazilian market and in accordance with the table of procedures of the Unified Health System (SUS). Outcomes will be evaluated using a health outcome unit that combines gain (or loss) in survival with quality of life, the unit is the quality-adjusted life year (quality adjusted life year, QALY). | Baseline, Month1, Month 2 and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Reuse needle, Insulin administration