Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus
Association of the Systemic Immune-inflammation Index (SII) and Severity of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Mellitus: A Retrospective Cohort Study
1 other identifier
observational
241
1 country
1
Brief Summary
Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2023
CompletedFirst Submitted
Initial submission to the registry
January 23, 2024
CompletedFirst Posted
Study publicly available on registry
February 9, 2024
CompletedFebruary 9, 2024
February 1, 2024
1.4 years
January 23, 2024
February 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SII
SII = (neutrophil × platelet) / lymphocyte.
Day 1 (baseline)
Secondary Outcomes (2)
ICU admission
Hospital stay up to one week
readmission
within 90 days
Study Arms (3)
mild DKA
pH \< 7.3 or serum bicarbonate \<18 mmol/L
moderate DKA
pH \< 7.2 or serum bicarbonate \<10 mmol/L
severe DKA
pH \< 7.1 or serum bicarbonate \<5 mmol/L
Interventions
IV fluids and IV insulin as per guidelines. reference 1-2
Eligibility Criteria
Type 1 DM hospitalized because of DKA.
You may qualify if:
- Diagnosis of T1DM
- Hospitalization because of DKA
- Age ≥ 12 years.
You may not qualify if:
- Diagnosis of T2DM
- Diagnosis of Infection
- Renal impairment
- Malignancy
- ASCVD (atherosclerotic cardiovascular disease)
- History of any medical condition or medications that can change CBC parameters or cause metabolic acidosis
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jahra Hospitallead
Study Sites (1)
Jahra Hospital
Kuwait, Al Jahra Governorate, 2675, Kuwait
Related Publications (2)
Dhatariya KK; Joint British Diabetes Societies for Inpatient Care. The management of diabetic ketoacidosis in adults-An updated guideline from the Joint British Diabetes Society for Inpatient Care. Diabet Med. 2022 Jun;39(6):e14788. doi: 10.1111/dme.14788. Epub 2022 Feb 27.
PMID: 35224769BACKGROUNDGlaser N, Fritsch M, Priyambada L, Rewers A, Cherubini V, Estrada S, Wolfsdorf JI, Codner E. ISPAD clinical practice consensus guidelines 2022: Diabetic ketoacidosis and hyperglycemic hyperosmolar state. Pediatr Diabetes. 2022 Nov;23(7):835-856. doi: 10.1111/pedi.13406. No abstract available.
PMID: 36250645BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MOHAMED AON, PHD
Cairo University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 23, 2024
First Posted
February 9, 2024
Study Start
August 1, 2021
Primary Completion
December 31, 2022
Study Completion
November 11, 2023
Last Updated
February 9, 2024
Record last verified: 2024-02