Protocol summary

Summary
The aim of this study is using of easier method of Fast-acting analogues of subcutaneous insulin to spending less, shorter hospital stay, no need to ICU care and better control of blood sugar, reduce diabetes complications and improve patients. All people with known diabetes type1 with following Criterion, participate in our study: blood sugar≥300mg/d, PH < 3/7, urine keton≥ +2 analysis, history of polydipsia, Frequenc, Enuresis, weight loss. determination of severity of DKA is according to PH: mild:PH=7.2 - 7.3, Mod: PH=7.1-7.2, severe: PH<7.1. exclusion criteria is: DKA caused by infections. patients with epilepcy or underline disease.patients with metabolic acidosis that treated with intra venous bicarbonate. patients become worse. 44 people 1 to 18 y are enrolled. After taking the content all patients by double blind method are divided in two groups, case and control. in control group, patients treat with Milwaukee method : Determination of dehydration, then treatment with Normal saline serum and from second hour insulin should be use. in case group, severity of dehydration estimates in patient with mild and mod DKA and treat.then aspart insulin(0/1 iu/kg) use, subcutaneous every 2 hours. Electrolysis imbalance, hypoglycemia, loss of consciousness and brain edema are Consequenceses.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610297654N3
Registration date: 2017-01-26, 1395/11/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-26, 1395/11/07
Registrant information
Name
Javad Faradmal
Name of organization / entity
Statistics Consultance
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 0966
Email address
javad.faradmal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of subcutaneous rapid acting and intravenous insulin treatments in mild and moderate diabetic ketoacidosis
Public title
Comparison of two insulin treatments in diabetic ketoacidosis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: blood sugar>300mg/d ; PH < 3.7; urine keton +2 or more with dipstick or in urine analysis ; history of polydipsia, Frequency, Enuresis, weight loss exclusion criteria: DKA caused by infections in patients;patients with epilepsy or underline disease;patients with endocrine disorders;patients with inborn error of metabolism patients with metabolic acidosis that treated with intravenous bicarbonate in an other center; patients that PH and dehydration's become worse
Age
From 1 year old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University Of Medical Sciences
Street address
Mardoom Park, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
6514845411
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.UMSHA.REC.1395.366

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
ABG
Timepoint
Every 4 hours
Method of measurement
Peripheral blood samples

2

Description
The number of hospitalization
Timepoint
end of study
Method of measurement
The number

3

Description
ICU admission
Timepoint
end of study
Method of measurement
The number

4

Description
sign of brain edema
Timepoint
daily
Method of measurement
Clinical

5

Description
electrolysis imbalance
Timepoint
Every 4 hours
Method of measurement
Peripheral blood samples

6

Description
Response time to treatment
Timepoint
Every 2 hours
Method of measurement
blood sugar with glucometer and ABG

7

Description
Hpoglycemia
Timepoint
Every 2 hours
Method of measurement
blood sugar with glucometer

Secondary outcomes

1

Description
hypoglycemia
Timepoint
every 2 hours
Method of measurement
blood sugar with glucometer

2

Description
electrolysis imbalance
Timepoint
every 4 hours
Method of measurement
Peripheral blood samples

3

Description
sign of brain edema
Timepoint
every 2 hours
Method of measurement
clinical

Intervention groups

1

Description
In case group, severity of dehydration estimates in patient with mild and mod DKA and treat.After second hour of treatment ,aspart insulin(0/1 iu/kg) use, subcutaneous every 2 hours until DKA has resolved
Category
Treatment - Drugs

2

Description
In control group, patients treat with regular insulin, 0/1 iu/kg, intravenous, infusion and continued until DKA has resolved
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Be'sat Hospital, Hamedan
Full name of responsible person
Dr Saba Maher
Street address
Be'sat Hospital, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Dr Zahra Razavi
Street address
Be'sat Hospital, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University Of Medical Sciences
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
Hamedan University Of Medical Sciences
Full name of responsible person
Dr Saba Maher
Position
Pediatrics Resident
Other areas of specialty/work
Street address
Hamedan, Be'sat Hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 3264 0051
Fax
Email
drs_maher@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University Of Medical Science
Full name of responsible person
Dr Zahra Razavi
Position
Pediatrics Endocrinologist
Other areas of specialty/work
Street address
Hamedan, Be'sat Hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 3264 0051
Fax
Email
drs_maher@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Saba Maher
Position
Pediatrics Resident
Other areas of specialty/work
Street address
Hamedan, Be'sat Hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 3264 0051
Fax
Email
drs_maher@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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