Diabetic KetoacidosisNCT07423559
Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients
A study testing insulin infusion without basal insulin, insulin infusion with basal insulin and Insulin infusion with basal insulin and bolus in people with Diabetic Ketoacidosis and Insulin, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Diabetic Ketoacidosis, Insulin, Intensive Care Unit Stay
- What is being tested?
- insulin infusion without basal insulin, insulin infusion with basal insulin and Insulin infusion with basal insulin and bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 21y or more
- who are known to have type 1 diabetes on known basal bolus insulin regimen - presented with diabetic ketoacidosis.
Who cannot join
- Patients with type 2 diabetes mellitus.
- If hemodynamically unstable patients.
- Patients with other metabolic problems (hepatic coma, renal failure, disturbed conscious level .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intensive Care Unit Stay and Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients
This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.
Read the detailed description
Diabetic ketoacidosis is one of the common, potentially serious, and avoidable acute complications of diabetes mellitus. Diabetic ketoacidosis is caused by a decrease in effective circulating insulin associated with elevations in counter-regulatory hormones . This potentially life-threatening complication of type 1.
diabetes mellitus is frequently mismanaged, leading to morbidity and increased length of stay. Advances in near-patient testing technology have improved patient care, by facilitating rapid diagnosis and closer monitoring of treatment response.
Diabetic ketoacidosis most often occurs in people with type 1 diabetes, but can also occur in patients with poorly controlled type 2 diabetes under stressful conditions .
Management of Diabetic ketoacidosis requires reversing metabolic derangements by correcting volume depletion and electrolyte imbalances and administering insulin to correct acidosis while concurrently treating the precipitating illness .
Diabetic ketoacidosis is traditionally managed using intravenous regular insulin infusion in intensive care unit /high dependency unit.
Fixed rate intravenous insulin infusion not only reduces blood glucose levels, but just as importantly, suppresses further ketogenesis, as well as correcting the electrolyte.
Basal insulin combination with Intervenors insulin infusion in acute management of Diabetic ketoacidosis could be protective against relapse with Diabetic ketoacidosis when abrupt interruption of insulin infusion is needed as in case of development of hypoglycemia during course of treatment or as in case of development of hypokalemia but this theory should be evaluated clinically. In our work, we are going to evaluate the effect of basal insulin continuation in acute management of Diabetic ketoacidosis to test the hypothesis that basal insulin continuation in acute management of Diabetic ketoacidosis could protect against relapse of ketoacidosis, hence shorten intensive care unit stay period of patient.
This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.
- Conditions
- Diabetic Ketoacidosis, Insulin, Intensive Care Unit Stay
- Being tested
- insulin infusion without basal insulin, insulin infusion with basal insulin, Insulin infusion with basal insulin and bolus
- Keywords
- Intensive Care Unit, Diabetic Ketoacidosis, Basal Bolus Insulin, Intravenous Insulin Infusion
- Medical subject headings
- Diabetic Ketoacidosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin infusion without basal insulinDrug
Group I : treated with insulin infusion without basal insulin.
insulin infusion with basal insulinDrug
Group II : treated with insulin infusion with basal insulin.
Insulin infusion with basal insulin and bolusDrug
Group III : treated with insulin infusion with basal insulin and bolus
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients treated with insulin infusion without basal insulin. Receives: Drug: insulin infusion without basal insulin |
| Group II | Experimental | Patients treated with insulin infusion with basal insulin. Receives: Drug: insulin infusion with basal insulin |
| Group III | Experimental | Patients treated with insulin infusion with basal insulin and bolus. Receives: Drug: Insulin infusion with basal insulin and bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of diabetic ketoacidosis
Criteria of resolution of Diabetic Ketoacidosis The anion gap (AG) <12 mEq/L. Venous pH >7.3. Serum bicarbonate ≥15 mEq/L
Measured: 4 days
Secondary outcomes (1)
Random blood sugar assessment
Measured: every 2 hours till 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start30 Nov 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Hashem Mahrous Saad, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423559
- Sponsor's protocol ID
- 36264MS408/11/23
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be obtained if it needed
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intensive Care Unit Stay and Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients
- ClinicalTrials.gov ID
- NCT07423559
- Acronym / sponsor ID
- 36264MS408/11/23
- Conditions
- Diabetic Ketoacidosis, Insulin, Intensive Care Unit Stay
- Keywords
- Intensive Care Unit, Diabetic Ketoacidosis, Basal Bolus Insulin, Intravenous Insulin Infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 20 Feb 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 study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.
Detailed description
Diabetic ketoacidosis is one of the common, potentially serious, and avoidable acute complications of diabetes mellitus. Diabetic ketoacidosis is caused by a decrease in effective circulating insulin associated with elevations in counter-regulatory hormones . This potentially life-threatening complication of type 1.
diabetes mellitus is frequently mismanaged, leading to morbidity and increased length of stay. Advances in near-patient testing technology have improved patient care, by facilitating rapid diagnosis and closer monitoring of treatment response.
Diabetic ketoacidosis most often occurs in people with type 1 diabetes, but can also occur in patients with poorly controlled type 2 diabetes under stressful conditions .
Management of Diabetic ketoacidosis requires reversing metabolic derangements by correcting volume depletion and electrolyte imbalances and administering insulin to correct acidosis while concurrently treating the precipitating illness .
Diabetic ketoacidosis is traditionally managed using intravenous regular insulin infusion in intensive care unit /high dependency unit.
Fixed rate intravenous insulin infusion not only reduces blood glucose levels, but just as importantly, suppresses further ketogenesis, as well as correcting the electrolyte.
Basal insulin combination with Intervenors insulin infusion in acute management of Diabetic ketoacidosis could be protective against relapse with Diabetic ketoacidosis when abrupt interruption of insulin infusion is needed as in case of development of hypoglycemia during course of treatment or as in case of development of hypokalemia but this theory should be evaluated clinically. In our work, we are going to evaluate the effect of basal insulin continuation in acute management of Diabetic ketoacidosis to test the hypothesis that basal insulin continuation in acute management of Diabetic ketoacidosis could protect against relapse of ketoacidosis, hence shorten intensive care unit stay period of patient.
This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: insulin infusion without basal insulinPatients treated with insulin infusion without basal insulin. |
| Group II | Experimental | Drug: insulin infusion with basal insulinPatients treated with insulin infusion with basal insulin. |
| Group III | Experimental | Drug: Insulin infusion with basal insulin and bolusPatients treated with insulin infusion with basal insulin and bolus. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients aged 21y or more
- who are known to have type 1 diabetes on known basal bolus insulin regimen - presented with diabetic ketoacidosis.
Key exclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus.
- If hemodynamically unstable patients.
- Patients with other metabolic problems (hepatic coma, renal failure, disturbed conscious level .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin infusion without basal insulinGroup I : treated with insulin infusion without basal insulin. | Drug | Group I |
| insulin infusion with basal insulinGroup II : treated with insulin infusion with basal insulin. | Drug | Group II |
| Insulin infusion with basal insulin and bolusGroup III : treated with insulin infusion with basal insulin and bolus | Drug | Group III |
Primary outcome
Resolution of diabetic ketoacidosis
Time frame: 4 days
Criteria of resolution of Diabetic Ketoacidosis The anion gap (AG) <12 mEq/L. Venous pH >7.3. Serum bicarbonate ≥15 mEq/L
1 secondary outcome
Random blood sugar assessment
Time frame: every 2 hours till 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. All data will be obtained if it needed
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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?
A study testing insulin infusion without basal insulin, insulin infusion with basal insulin and Insulin infusion with basal insulin and bolus in people with Diabetic Ketoacidosis and Insulin, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Feb 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution of diabetic ketoacidosis (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.