Diabetes Mellitus, Type 2NCT04460092
Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose
A study testing 5-mm 32-gauge Insulin needles in the first three days of Intervention, 8-mm 32-gauge Insulin needles in the first three days of Intervention and 5-mm 32-gauge Insulin needles in the last three days of Intervention in people with Diabetes Mellitus, Type 2, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 5-mm 32-gauge Insulin needles in the first three days of Intervention, 8-mm 32-gauge Insulin needles in the first three days of Intervention and 5-mm 32-gauge Insulin needles in the last three days of Intervention
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 25 May 2020to 25 Sep 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having type II diabetes
- Use injectable insulin for at least two years
- BMI >18
- Lack of mental illness and mental retardation
- Use insulin pen
Who cannot join
- Lack of desire to participate in the study
- Having a skin problem in the injection site
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mohammad Sadegh Bagheri Baghdasht
Tehran, 0
Mohammad Sadegh Bagheri Baghdasht
About this study
Official title: The Effect of Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose Control in Type - II Diabetic Patients in Baqiyatollah Hospital and Clinic, Tehran, 2019 -2020
This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.
Read the detailed description
This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.
After entering the data in SPSS20 software, the collected data will be analyzed using descriptive statistics (frequency, percentage, mean, standard deviation) and statistical tests (t-test, chi-square).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 5-mm 32-gauge Insulin needles in the first three days of Intervention, 8-mm 32-gauge Insulin needles in the first three days of Intervention, 5-mm 32-gauge Insulin needles in the last three days of Intervention, 8-mm 32-gauge Insulin needles in the last three days of Intervention
- Keywords
- Diabetes Mellitus, Type 2, Blood Glucose, Pain, leakage, insulin injections
- Medical subject headings
- Diabetes Mellitus, Type 2, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-mm 32-gauge Insulin needles in the first three days of InterventionDevice
32-gauge needles with a length of 5mm to inject insulin in first three days
8-mm 32-gauge Insulin needles in the first three days of InterventionDevice
32-gauge needles with a length of 8mm to inject insulin in first three days
5-mm 32-gauge Insulin needles in the last three days of InterventionDevice
32-gauge needles with a length of 5mm to inject insulin in second three days
8-mm 32-gauge Insulin needles in the last three days of InterventionDevice
32-gauge needles with a length of 8mm to inject insulin in second three days
| Study group | Role | What they receive |
|---|---|---|
| Group "A" | Experimental | In the first three days, participants in group "A" will inject 90-degree insulin injections using 5-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 8 mm to inject insulin. Receives: Device: 5-mm 32-gauge Insulin needles in the first three days of Intervention; Device: 8-mm 32-gauge Insulin needles in the last three days of Intervention |
| Group"B" | Experimental | In the first three days, participants in group "B" will inject 90-degree insulin injections using 8-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 5mm to inject insulin. Receives: Device: 8-mm 32-gauge Insulin needles in the first three days of Intervention; Device: 5-mm 32-gauge Insulin needles in the last three days of Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Laboratory check the Plasma glucose according to the routine of the hospital units
Measured: Up to 7 days
Insulin leakage
The rate of insulin leakage after injection is observational
Measured: Up to 7 days
Pain when insulin injection
Survey severity pain when insulin injection by Visual Analogue Scale (VAS). This is a numerical scale that tells the patient the severity of their pain from one to ten. The larger the number, the more pain there is.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start25 May 2020
- Primary completion29 Jun 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
- Investigators
- Esmail Heidaranlu, Study chair, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460092
- Sponsor's protocol ID
- IR.BMSU.BAQ.REC.1398.059
- Status last verified
- Jul 2020
- First submitted
- 10 May 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose Control in Type - II Diabetic Patients in Baqiyatollah Hospital and Clinic, Tehran, 2019 -2020
- ClinicalTrials.gov ID
- NCT04460092
- Acronym / sponsor ID
- IR.BMSU.BAQ.REC.1398.059
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Blood Glucose, Pain, leakage, insulin injections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 29 Jun 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 7 Jul 2020 (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.
This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.
Detailed description
This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.
After entering the data in SPSS20 software, the collected data will be analyzed using descriptive statistics (frequency, percentage, mean, standard deviation) and statistical tests (t-test, chi-square).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "A" | Experimental | Device: 5-mm 32-gauge Insulin needles in the first three days of Intervention, Device: 8-mm 32-gauge Insulin needles in the last three days of InterventionIn the first three days, participants in group "A" will inject 90-degree insulin injections using 5-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 8 mm to inject insulin. |
| Group"B" | Experimental | Device: 8-mm 32-gauge Insulin needles in the first three days of Intervention, Device: 5-mm 32-gauge Insulin needles in the last three days of InterventionIn the first three days, participants in group "B" will inject 90-degree insulin injections using 8-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 5mm to inject insulin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having type II diabetes
- Use injectable insulin for at least two years
- BMI >18
- Lack of mental illness and mental retardation
- Use insulin pen
Key exclusion criteria (2 listed)
- Lack of desire to participate in the study
- Having a skin problem in the injection site
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 |
|---|---|---|
| 5-mm 32-gauge Insulin needles in the first three days of Intervention32-gauge needles with a length of 5mm to inject insulin in first three days | Device | Group "A" |
| 8-mm 32-gauge Insulin needles in the first three days of Intervention32-gauge needles with a length of 8mm to inject insulin in first three days | Device | Group"B" |
| 5-mm 32-gauge Insulin needles in the last three days of Intervention32-gauge needles with a length of 5mm to inject insulin in second three days | Device | Group"B" |
| 8-mm 32-gauge Insulin needles in the last three days of Intervention32-gauge needles with a length of 8mm to inject insulin in second three days | Device | Group "A" |
Primary outcome
Plasma glucose
Time frame: Up to 7 days
Laboratory check the Plasma glucose according to the routine of the hospital units
Insulin leakage
Time frame: Up to 7 days
The rate of insulin leakage after injection is observational
Pain when insulin injection
Time frame: Up to 7 days
Survey severity pain when insulin injection by Visual Analogue Scale (VAS). This is a numerical scale that tells the patient the severity of their pain from one to ten. The larger the number, the more pain there is.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
Esmail Heidaranlu study chair
Baqiyatallah Medical Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-mm 32-gauge Insulin needles in the first three days of Intervention, 8-mm 32-gauge Insulin needles in the first three days of Intervention and 5-mm 32-gauge Insulin needles in the last three days of Intervention in people with Diabetes Mellitus, Type 2, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Sadegh Bagheri Baghdasht (0098 936 8214509, hiasdasd0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose (time frame: Up to 7 days). 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 7 Jul 2020.