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

NCT05407233 | Completed

• 1 other identifier: 2018-0574
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Reuse needle; Insulin administration

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Evaluate the quality of needles after reuse of the insulin administration needle compared to non-reuse.

  Month 2

• Evaluate the microbiological contamination after reuse of the insulin administration needle compared to non-reuse.

  Month 2

• Insulin Injection technique

  Baseline and Month 3

• Adherence to diabetes treatment

  Baseline, Month1, Month 2 and Month 3

• Quality of life assessment

  Baseline, Month1, Month 2 and Month 3

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Doesn´t reuse the syringe for insulin application

Device: Does not reuse the syringe for insulin application

Group 2

EXPERIMENTAL

Uses the syringe five times to insulin application

Device: Uses the syringe for insulin delivery five times

Interventions

Does not reuse the syringe for insulin application 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 1

Uses the syringe for insulin delivery five times 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.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Gabriela Berlanda

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Beatriz D Agord Schaan, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was blinded to the professionals involved in the analyses of skin complications and the needle characterization test.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 7, 2022
• Study Start: October 14, 2019
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)