The study was an experimental with Randomized Complete Block Design (RCBD). The population were patients with diabetes mellitus type 2 in dr. Moewardi Hospital Solo, Central Java consisted of 60 respondents taken from simple random sampling and the respondents were divided into 4 blocks. Injection used was Rapid-acting insulin with the dosage prescribed by the doctor. Injection was done in four (4) locations; abdomen, deltoid, thigh and gluteus. The administration were 0 minutes (along with meals), 10 minutes before meal, 20 minutes before meal and 30 minutes before meal. Postprandial glucose levels were measured using a Glucometer. Data were then analyzed by SPSS 18 with Two-Way ANOVA and Tukey HSD.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062134690N1
Registration date:2017-07-12, 1396/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Agus Santosa
Name of organization / entity
Universitas Muhammadiyah Purwokerto
Country
Indonesia
Phone
006285328111986
Email address
agussantosa@ump.ac.id
Recruitment status
Recruitment complete
Funding source
Self
Expected recruitment start date
2015-05-01, 1394/02/11
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Insulin Injection Site and Time Interval Administration for the Postprandial Glucose Control in Patient with Diabetes Type 2
Public title
This study aimed to determine the effects of insulin injection site and interval timing to the control of postprandial glucose in diabetes mellitus patients type 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient diabetes melitus type2; Age min 40 years old; used insulin therapy, Exclusion criteria: Patient diabetes melitus type2 with complication diabetic (neuropati diabetic, retinopati diabetic, nefropati diabetic); Hiperosmolalitas ketoasidosi; Used Oral Antihyperglycemic Drugs
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized Complete Block Design (RCBD)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Universitas Muhammadiyah Yogyakarta
Street address
Jl. Lingkar Selatan, Kasihan, Tamantirto, Bantul, Tamantirto, Kasihan, Yogya, Daerah Istimewa Yogyakarta, Indonesia
City
Bantul
Postal code
55183
Approval date
2015-05-15, 1394/02/25
Ethics committee reference number
441/EP-FKIK UMY/2015
Health conditions studied
1
Description of health condition studied
Patient with diabetes type 2
ICD-10 code
E10-E14
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
postprandial glucose
Timepoint
2 hour postprandial
Method of measurement
Glucometer
Secondary outcomes
1
Description
Time Interval Administration
Timepoint
0-30 minutes
Method of measurement
timer
Intervention groups
1
Description
Intervention I/Block I: Insulin injections in the abdomen, deltoid, thigh and gluteus at the time of administration were 0 minutes (along with meals). Types of insulin administered was Rapid-acting insulin at a dose prescribed by the doctor
Category
Treatment - Other
2
Description
Intervention II/Block II: Insulin injections in the abdomen, deltoid, thigh and gluteus at the time of administration were 10 minutes before meal. Types of insulin administered was Rapid-acting insulin at a dose prescribed by the doctor
Category
Treatment - Other
3
Description
Intervention III/Block III: Insulin injections in the abdomen, deltoid, thigh and gluteus at the time of administration were 20 minutes before meal. Types of insulin administered was Rapid-acting insulin at a dose prescribed by the doctor
Category
Treatment - Other
4
Description
Intervention IV/Block IV: Insulin injections in the abdomen, deltoid, thigh and gluteus at the time of administration were 30 minutes before meal. Types of insulin administered was Rapid-acting insulin at a dose prescribed by the doctor
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Universitas Muhammadiyah Purwokerto
Full name of responsible person
Agus Santosa
Street address
Jl. Raya Dukuhwaluh, Dukuhwaluh, Kembaran, Kabupaten Banyumas, Jawa Tengah 53182, Indonesia
City
Banyumas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Agus Santosa
Full name of responsible person
Agus
Street address
Desa Linggasari RT6/RW6 Kecamatan Kembaran, Kabupaten Banyumas, Provinsi Jawa Tengah
City
Banyumas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Agus Santosa
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Universitas Muhammadiyah Purwokerto
Full name of responsible person
Ikhsan Mujahid
Position
Dean
Other areas of specialty/work
Street address
Jl. Letjen Soepardjo Roestam Km7 Purwokerto
City
Banyumas
Province
Jawa tengah
Postal code
53181
Phone
+620281636751
Fax
Email
info@ump.ac.id
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Universitas Muhammadiyah Purwokerto
Full name of responsible person
Suwarno
Position
Head Of Reseach Centre Universitas Muhammadiyah Purwokerto
Other areas of specialty/work
Street address
Jl. Raya Dukuhwaluh, Dukuhwaluh, Kembaran, Kabupaten Banyumas, Jawa Tengah 53182, Indonesia
City
Banyumas
Province
Jawa tengah
Postal code
53181
Phone
006281636751
Fax
Email
info@ump.ac.id
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Universitas Muhammadiyah Purwokerto
Full name of responsible person
Agus Santosa
Position
Other areas of specialty/work
Street address
Jl. Letjen Soepardjo Roestam Km7 Purwokerto
City
Banyumas
Province
Jawa tengah
Postal code
53181
Phone
00
Fax
Email
agussantosa@ump.ac.id
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)