Diabetes Mellitus, Type 2NCT05407233
Reusing Needles for Subcutaneous Insulin Injection in Patients With Type 2 Diabetes
A study testing Does not reuse the syringe for insulin application and Uses the syringe for insulin delivery five times in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Does not reuse the syringe for insulin application and Uses the syringe for insulin delivery five times
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Oct 2019to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T2DM
- Over 18 years of age
- Reuses each syringe at least three times for insulin application.
Who cannot join
- Use of insulin pens
- Pregnant women
- Patients undergoing chemotherapy
- Use of anticoagulants
- Clotting disorders, lesions or skin changes
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Does not reuse the syringe for insulin application, Uses the syringe for insulin delivery five times
- Keywords
- Diabetes Mellitus, Type 2, Reuse needle, Insulin administration
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Does not reuse the syringe for insulin applicationDevice
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.
Uses the syringe for insulin delivery five timesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Doesn´t reuse the syringe for insulin application Receives: Device: Does not reuse the syringe for insulin application |
| Group 2 | Experimental | Uses the syringe five times to insulin application Receives: Device: Uses the syringe for insulin delivery five times |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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").
Measured: 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.
Needle quality evaluation will be performed through the penetration test and drag through using the Mecmesin digital dynamometer (Advanced Force Gauge).
Measured: 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).
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, Month1, Month 2 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start14 Oct 2019
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz D Agord Schaan, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407233
- Sponsor's protocol ID
- 2018-0574
- Status last verified
- Oct 2023
- First submitted
- 26 May 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05407233
- Acronym / sponsor ID
- 2018-0574
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Reuse needle, Insulin administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Does not reuse the syringe for insulin applicationDoesn´t reuse the syringe for insulin application |
| Group 2 | Experimental | Device: Uses the syringe for insulin delivery five timesUses the syringe five times to insulin application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with T2DM
- Over 18 years of age
- Reuses each syringe at least three times for insulin application.
Key exclusion criteria (5 listed)
- Use of insulin pens
- Pregnant women
- Patients undergoing chemotherapy
- Use of anticoagulants
- Clotting disorders, lesions or skin changes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Does not reuse the syringe for insulin applicationDoes 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. | Device | Group 1 |
| Uses the syringe for insulin delivery five timesUses 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. | Device | Group 2 |
Primary outcome
Change in glycemic control
Time frame: Baseline and Month 3
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.
Change in Skin complications
Time frame: Baseline, Month1, Month 2 and Month 3
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.
Change in Pain assessment
Time frame: Baseline, Month1, Month 2 and Month 3
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").
8 secondary outcomes
Evaluate the quality of needles after reuse of the insulin administration needle compared to non-reuse.
Time frame: Month 2
Evaluate the microbiological contamination after reuse of the insulin administration needle compared to non-reuse.
Time frame: Month 2
Insulin Injection technique
Time frame: Baseline and Month 3
Adherence to diabetes treatment
Time frame: Baseline, Month1, Month 2 and Month 3
Quality of life assessment
Time frame: Baseline, Month1, Month 2 and Month 3
Frequency of capillary blood glucose tests
Time frame: Baseline
Frequency of reuse of lancets of included patients
Time frame: Baseline
Analyze cost-utility
Time frame: Baseline, Month1, Month 2 and Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz D Agord Schaan, PhD study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Does not reuse the syringe for insulin application and Uses the syringe for insulin delivery five times in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic control (time frame: Baseline and Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.