Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose

NCT ID: NCT04460092

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2020-09-25

Brief Summary

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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

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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

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group "A"

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.

Group Type EXPERIMENTAL

5-mm 32-gauge Insulin needles in the first three days of Intervention

Intervention Type DEVICE

32-gauge needles with a length of 5mm to inject insulin in first three days

8-mm 32-gauge Insulin needles in the last three days of Intervention

Intervention Type DEVICE

32-gauge needles with a length of 8mm to inject insulin in second three days

Group"B"

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.

Group Type EXPERIMENTAL

8-mm 32-gauge Insulin needles in the first three days of Intervention

Intervention Type DEVICE

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 Intervention

Intervention Type DEVICE

32-gauge needles with a length of 5mm to inject insulin in second three days

Interventions

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5-mm 32-gauge Insulin needles in the first three days of Intervention

32-gauge needles with a length of 5mm to inject insulin in first three days

Intervention Type DEVICE

8-mm 32-gauge Insulin needles in the first three days of Intervention

32-gauge needles with a length of 8mm to inject insulin in first three days

Intervention Type DEVICE

5-mm 32-gauge Insulin needles in the last three days of Intervention

32-gauge needles with a length of 5mm to inject insulin in second three days

Intervention Type DEVICE

8-mm 32-gauge Insulin needles in the last three days of Intervention

32-gauge needles with a length of 8mm to inject insulin in second three days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Having type II diabetes
* Use injectable insulin for at least two years
* BMI \>18
* Lack of mental illness and mental retardation
* Use insulin pen

Exclusion Criteria

* Lack of desire to participate in the study
* Having a skin problem in the injection site
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baqiyatallah Medical Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Sadegh Bagheri Baghdasht

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esmail Heidaranlu

Role: STUDY_CHAIR

Baqiyatallah Medical Sciences University

Locations

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Mohammad Sadegh Bagheri Baghdasht

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohammad Sadegh Bagheri Baghdasht

Role: CONTACT

0098 936 8214509

Facility Contacts

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Mohammad Sadegh Bagheri Baghdasht

Role: primary

Other Identifiers

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IR.BMSU.BAQ.REC.1398.059

Identifier Type: -

Identifier Source: org_study_id

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