Diabete Type 1NCT07377604
Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients
An observational study of Diabete Type 1 and Ketoacidosis, Diabetic, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational cohort study aims to evaluate the association between hemoglobin levels and the time to resolution of diabetic ketoacidosis (DKA) in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Diabete Type 1, Ketoacidosis, Diabetic, Pediatrics
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2013to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients treated for DKA in the pediatric emergency department and pediatric intensive care unit of a tertiary university hospital.
Who may be able to join
- Age between 1 and 18 years
- Diagnosis of diabetic ketoacidosis (DKA) according to ISPAD criteria
- First documented episode of DKA
- Availability of hemoglobin measurement obtained within 0-24 hours after biochemical resolution of DKA
- Availability of documented timestamps for initiation of DKA treatment and biochemical resolution
Who cannot join
- Hyperosmolar hyperglycemic state (HHS) or mixed DKA-HHS presentation
- Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease)
- Evidence of active hemolysis documented in medical records (e.g., elevated lactate dehydrogenase, indirect hyperbilirubinemia, or low haptoglobin)
- Red blood cell transfusion administered before or during the DKA treatment period
- Missing hemoglobin measurement within the predefined post-resolution window (0-24 hours)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Anemia on Time to Resolution of Diabetic Ketoacidosis and Hospital Outcomes in Children: A Single-Center Retrospective Cohort Study
This retrospective observational cohort study aims to evaluate the association between hemoglobin levels and the time to resolution of diabetic ketoacidosis (DKA) in pediatric patients. The primary hypothesis is that children with anemia experience a longer duration of DKA and prolonged hospitalization compared with non-anemic children. All eligible patients aged 1-18 years who were diagnosed with DKA between 01.01.2013 and 01.01.2025 at a tertiary pediatric center will be included. Clinical, laboratory, and treatment data will be collected from electronic medical records.
Read the detailed description
This retrospective observational study investigates whether hemoglobin (Hb) levels, measured within 0-24 hours after biochemical resolution of diabetic ketoacidosis (DKA), are associated with the time to DKA resolution in pediatric patients. DKA resolution is defined as achievement of a venous pH ≥ 7.30 and a serum bicarbonate level ≥ 15 mmol/L. Only the first documented DKA episode for each patient will be included in the analysis.
Secondary outcomes include pediatric intensive care unit (PICU) length of stay, total hospital length of stay, and DKA-related complications such as hypoglycemia, electrolyte disturbances, and suspected cerebral edema. Exploratory analyses will assess the association of pre-DKA hemoglobin levels (when available), hemoglobin levels at hospital discharge, and dehydration severity-reflected by admission hematocrit-with clinical outcomes.
- Conditions
- Diabete Type 1, Ketoacidosis, Diabetic, Pediatrics, Child
- Keywords
- Anemia, Ketoacidosis, Diabetic, Child, Hemoglobin, pediatric emergency
- Medical subject headings
- Diabetic Ketoacidosis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients With Diabetic Ketoacidosis | Children and adolescents aged 1-18 years diagnosed with diabetic ketoacidosis (DKA) according to ISPAD criteria. All patients included in this cohort were managed according to standard institutional DKA treatment protocols. Hemoglobin levels were assessed after biochemical resolution of DKA, and patients were categorized analytically as anemic or non-anemic for outcome comparisons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Resolution of Diabetic Ketoacidosis
Time from initiation of DKA treatment to biochemical resolution of DKA. Biochemical resolution is defined as achievement of a venous pH ≥ 7.30 and a serum bicarbonate level ≥ 15 mmol/L. The outcome is measured in hours and analyzed in relation to hemoglobin levels measured within 0-24 hours after DKA resolution.
Measured: From initiation of DKA treatment until biochemical resolution, assessed up to 7 days
Secondary outcomes (2)
Pediatric Intensive Care Unit (PICU) Length of Stay
Length of stay in the pediatric intensive care unit measured from PICU admission to PICU discharge. The association with post-resolution hemoglobin levels will be evaluated.
Measured: From PICU admission until PICU discharge, assessed up to 30 days
Total Hospital Length of Stay
Total length of hospital stay measured from hospital admission to hospital discharge. The association between hospital length of stay and post-resolution hemoglobin levels will be evaluated.
Measured: From hospital admission until hospital discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start11 Nov 2013
- Primary completionDec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 1Studies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Çağlar, MD, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377604
- Sponsor's protocol ID
- ADUPEDDKAHB2025
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared publicly due to institutional policies, ethical restrictions, and the retrospective nature of the study using routinely collected clinical data. Aggregate data and statistical code may be provided upon reasonable request, subject to institutional approval.
Publications
Małachowska, B., Michałek, D., Koptas, M., Pietras, W., Młynarski, W., Szadkowska, A., & Fendler, W. (2020). Changes in hematological parameters during first days of diabetic ketoacidosis treatment in children with type 1 diabetes mellitus. Clinical Diabetology, 9(3), 149-160. https://doi.org/10.5603/DK.2020.0006
Safinaz AE, Asmaa AS,Nouran Y,Rasha AT. Iron Deficiency Anemia in Children and Adolescents with Type I Diabetes, Is it a Real Problem?. The Medical Journal of Cairo University. 2021 Sep 89; 1603-19.
Forestell B, Battaglia F, Sharif S, Eltorki M, Samaan MC, Choong K, Rochwerg B. Insulin Infusion Dosing in Pediatric Diabetic Ketoacidosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Explor. 2023 Feb 17;5(2):e0857. doi: 10.1097/CCE.0000000000000857. eCollection 2023 Feb.
PubMed 36844374Getawa S, Adane T. Hematological abnormalities among adults with type 1 diabetes mellitus at the University of Gondar Comprehensive Specialized Hospital. SAGE Open Med. 2022 Apr 24;10:20503121221094212. doi: 10.1177/20503121221094212. eCollection 2022.
PubMed 35492887Kostopoulou E, Sinopidis X, Fouzas S, Gkentzi D, Dassios T, Roupakias S, Dimitriou G. Diabetic Ketoacidosis in Children and Adolescents; Diagnostic and Therapeutic Pitfalls. Diagnostics (Basel). 2023 Aug 4;13(15):2602. doi: 10.3390/diagnostics13152602.
PubMed 37568965Faghir-Ganji M, Abdolmohammadi N, Nikbina M, Amanollahi A, Ansari-Moghaddam A, Rozhan R, Baradaran H. Prevalence of Anemia in Patients with Diabetes Mellitus: A Systematic Review and Meta-Analysis. Biomed Environ Sci. 2024 Jan 20;37(1):96-107. doi: 10.3967/bes2024.008.
PubMed 38326724
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anemia on Time to Resolution of Diabetic Ketoacidosis and Hospital Outcomes in Children: A Single-Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07377604
- Acronym / sponsor ID
- ADUPEDDKAHB2025
- Conditions
- Diabete Type 1, Ketoacidosis, Diabetic, Pediatrics, Child
- Keywords
- Anemia, Ketoacidosis, Diabetic, Child, Hemoglobin, pediatric emergency
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational cohort study aims to evaluate the association between hemoglobin levels and the time to resolution of diabetic ketoacidosis (DKA) in pediatric patients. The primary hypothesis is that children with anemia experience a longer duration of DKA and prolonged hospitalization compared with non-anemic children. All eligible patients aged 1-18 years who were diagnosed with DKA between 01.01.2013 and 01.01.2025 at a tertiary pediatric center will be included. Clinical, laboratory, and treatment data will be collected from electronic medical records.
Detailed description
This retrospective observational study investigates whether hemoglobin (Hb) levels, measured within 0-24 hours after biochemical resolution of diabetic ketoacidosis (DKA), are associated with the time to DKA resolution in pediatric patients. DKA resolution is defined as achievement of a venous pH ≥ 7.30 and a serum bicarbonate level ≥ 15 mmol/L. Only the first documented DKA episode for each patient will be included in the analysis.
Secondary outcomes include pediatric intensive care unit (PICU) length of stay, total hospital length of stay, and DKA-related complications such as hypoglycemia, electrolyte disturbances, and suspected cerebral edema. Exploratory analyses will assess the association of pre-DKA hemoglobin levels (when available), hemoglobin levels at hospital discharge, and dehydration severity-reflected by admission hematocrit-with clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients With Diabetic Ketoacidosis | – | –Children and adolescents aged 1-18 years diagnosed with diabetic ketoacidosis (DKA) according to ISPAD criteria. All patients included in this cohort were managed according to standard institutional DKA treatment protocols. Hemoglobin levels were assessed after biochemical resolution of DKA, and patients were categorized analytically as anemic or non-anemic for outcome comparisons. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients treated for DKA in the pediatric emergency department and pediatric intensive care unit of a tertiary university hospital.
Key inclusion criteria (5 listed)
- Age between 1 and 18 years
- Diagnosis of diabetic ketoacidosis (DKA) according to ISPAD criteria
- First documented episode of DKA
- Availability of hemoglobin measurement obtained within 0-24 hours after biochemical resolution of DKA
- Availability of documented timestamps for initiation of DKA treatment and biochemical resolution
Key exclusion criteria (5 listed)
- Hyperosmolar hyperglycemic state (HHS) or mixed DKA-HHS presentation
- Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease)
- Evidence of active hemolysis documented in medical records (e.g., elevated lactate dehydrogenase, indirect hyperbilirubinemia, or low haptoglobin)
- Red blood cell transfusion administered before or during the DKA treatment period
- Missing hemoglobin measurement within the predefined post-resolution window (0-24 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Resolution of Diabetic Ketoacidosis
Time frame: From initiation of DKA treatment until biochemical resolution, assessed up to 7 days
Time from initiation of DKA treatment to biochemical resolution of DKA. Biochemical resolution is defined as achievement of a venous pH ≥ 7.30 and a serum bicarbonate level ≥ 15 mmol/L. The outcome is measured in hours and analyzed in relation to hemoglobin levels measured within 0-24 hours after DKA resolution.
2 secondary outcomes
Pediatric Intensive Care Unit (PICU) Length of Stay
Time frame: From PICU admission until PICU discharge, assessed up to 30 days
Total Hospital Length of Stay
Time frame: From hospital admission until hospital discharge, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- BackgroundMałachowska, B., Michałek, D., Koptas, M., Pietras, W., Młynarski, W., Szadkowska, A., & Fendler, W. (2020). Changes in hematological parameters during first days of diabetic ketoacidosis treatment in children with type 1 diabetes mellitus. Clinical Diabetology, 9(3), 149-160. https://doi.org/10.5603/DK.2020.0006
- BackgroundSafinaz AE, Asmaa AS,Nouran Y,Rasha AT. Iron Deficiency Anemia in Children and Adolescents with Type I Diabetes, Is it a Real Problem?. The Medical Journal of Cairo University. 2021 Sep 89; 1603-19.
- Background: PubMed 36844374Forestell B, Battaglia F, Sharif S, Eltorki M, Samaan MC, Choong K, Rochwerg B. Insulin Infusion Dosing in Pediatric Diabetic Ketoacidosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Explor. 2023 Feb 17;5(2):e0857. doi: 10.1097/CCE.0000000000000857. eCollection 2023 Feb.
- Background: PubMed 35492887Getawa S, Adane T. Hematological abnormalities among adults with type 1 diabetes mellitus at the University of Gondar Comprehensive Specialized Hospital. SAGE Open Med. 2022 Apr 24;10:20503121221094212. doi: 10.1177/20503121221094212. eCollection 2022.
- Background: PubMed 37568965Kostopoulou E, Sinopidis X, Fouzas S, Gkentzi D, Dassios T, Roupakias S, Dimitriou G. Diabetic Ketoacidosis in Children and Adolescents; Diagnostic and Therapeutic Pitfalls. Diagnostics (Basel). 2023 Aug 4;13(15):2602. doi: 10.3390/diagnostics13152602.
- Background: PubMed 38326724Faghir-Ganji M, Abdolmohammadi N, Nikbina M, Amanollahi A, Ansari-Moghaddam A, Rozhan R, Baradaran H. Prevalence of Anemia in Patients with Diabetes Mellitus: A Systematic Review and Meta-Analysis. Biomed Environ Sci. 2024 Jan 20;37(1):96-107. doi: 10.3967/bes2024.008.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared publicly due to institutional policies, ethical restrictions, and the retrospective nature of the study using routinely collected clinical data. Aggregate data and statistical code may be provided upon reasonable request, subject to institutional approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 1 and Ketoacidosis, Diabetic, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of Diabetic Ketoacidosis (time frame: From initiation of DKA treatment until biochemical resolution, assessed up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07377604, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.