Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Blood Glucose, Pain, leakage, insulin injections
Brief 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 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).
Interventions
DEVICE5-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
DEVICE8-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
DEVICE5-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
DEVICE8-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
Sponsors
Baqiyatallah Medical Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose | Up to 7 days | Laboratory check the Plasma glucose according to the routine of the hospital units |
| Insulin leakage | Up to 7 days | The rate of insulin leakage after injection is observational |
| Pain when insulin injection | 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. |
Countries
Iran
Contacts
Primary ContactMohammad Sadegh Bagheri Baghdasht
Outcome results
None listed