Diabetic KetoacidosisLOSTINDIABNCT05443802
Comparison of a Low Dose to a Standard Dose of Insulin in Adult DKA in ICU to Reduce Metabolic Complications
A study testing Insulin 0.05 IU/kg/h and Insulin 0.10 IU/kg/h in people with Diabetic Ketoacidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- Insulin 0.05 IU/kg/h and Insulin 0.10 IU/kg/h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2022to 31 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or above
- Admission in Intense/Intermediate Care Unit
- Severe DKA due to all types of diabetes (T1D, T2D and secondary diabetes and inaugural ketoacidosis) defined by association of the following 3 parameters:
- glucose > 11 mmol/L or affirmation of having diabetes
- ketonemia > 3mmol/L or ketonuria ≥ 2
- bicarbonate < 15 mmol/L and/or venous pH < or=7.3
- Randomization possible before 15UI of insulin administrated in total
- Informed and written consent. In the absence of parent/ relative/ person of trust, the patient may be included via the emergency procedure and consent will be obtained as soon as possible
Who cannot join
- Non-diabetic ketoacidosis (fasting or alcoholic)
- Patient weighing less than 30 kg
- Hypokalemia < 3.5 mmol/L at the time of inclusion
- Hyperosmolar hyperglycemic state (defined as efficient plasma osmolarity > 320 mosmol/L)
- Absence of social security coverage
- Pregnant or breastfeeding patient
Show all 12Show fewer
- Patient under tutelage or curators
- Patient deprived of liberty due to a judicial or administrative decision
- Patient with a renal disease requiring dialysis
- Acute or chronic liver failure with Factor V < 50%
- Patient receiving a high dose of corticosteroids (≥ 0.5 mg/kg) daily
- Patient included in another interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Low Dose to a Standard Dose of Insulin in Adult Diabetic Ketoacidosis in ICU to Reduce Metabolic Complications : a Randomized, Controlled Study
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss).
Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more a matter of insulin resistance than an absolute deficiency. However, international guidelines recommend a similar dose of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.
Read more
During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.
The research hypothesis is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.
Read the detailed description
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria which leads to major losses of water, sodium and potassium as well as the generation of metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss and acidosis).
Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more insulin resistance than absolute deficiency. However, international guidelines recommend a similar dosage of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.
During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.
A British study reported 27.6% hypoglycaemia and 55% hypokalemia during the first 24 hours of treatment. Comparable figures were observed by conducting a multicenter retrospective study of 122 patients: hypokalaemia and hypoglycaemia were observed in nearly two thirds of cases.
A pediatric study showed that a lower dose of insulin (0.05 IU/kg/h) reduced the rate of hypoglycaemia (20% vs 4%) and hypokalaemia (48% vs 20%) compared to at the standard dose (0.10 IU/kg/h) without modifying the time to resolution. But the very small number (25 children per arm), the questionable statistical analysis and the pediatric population (T1D only) do not make it possible to anticipate the potential benefit in a much more heterogeneous adult population.
The hypothesis of the research is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- Insulin 0.05 IU/kg/h, Insulin 0.10 IU/kg/h
- Keywords
- Diabetic ketoacidosis, Insulin deficiency, Hypoglycemia, Hypokalemia, Metabolic complications
- Medical subject headings
- Diabetic Ketoacidosis, Hypoglycemia, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin 0.05 IU/kg/hDrug
In the experimental arm, the patients will be given an insulin dose of 0.05 IU/kg/h.
Insulin 0.10 IU/kg/hDrug
In the control arm, patients will receive an insulin dose of 0.10 IU/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Reduced dose of rapid-acting insulin of 0.05 IU/kg/h from randomization until resolution of DKA Receives: Drug: Insulin 0.05 IU/kg/h |
| Control | Other | Rapid-acting insulin dose of 0.10 IU/kg/h in accordance with usual recommendations until resolution of DKA Receives: Drug: Insulin 0.10 IU/kg/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic complications
Proportion of patients with metabolic complications (hypokalaemia <3.5 mmol/L and/or hypoglycemia <3.9 mmol/L) treated with a reduced dose of insulin (0.05 IU/kg/h) compared with the control group receiving the 0.10 IU/kg/h dose.
Measured: 48 hours
Secondary outcomes (22)
Resolution of diabetic ketoacidosis
Time in hours between randomisation and resolution of diabetic ketoacidosis (defined by ph>7.3 and ketonemia < 3 mmol/L and bicarbonates> 15 mmol/L)
Measured: 48 hours
Episode of hypokalaemia
Proportion of patients with at least one episode of hypokalaemia < 3.5 mmol/L between randomization and resolution of DKA
Measured: 48 hours
Episode of hypoglycemia
Proportion of patients with at least one episode of hypoglycemia < 3.9 mmol/L between randomization and resolution of DKA
Measured: 48 hours
Episode of severe hypoglycemia
Proportion of patients with at least one episode of hypoglycemia < 2.9 mmol/L between randomization and resolution of DKA
Measured: 48 hours
Cardiac arrythmia diagnosed by EKG
Proportion of patients with onset of new cardiac arrhythmia diagnosed by EKG analysis (atrial fibrillation and ventricular arrhythmia) and scopic monitoring between randomization and resolution of DKA
Measured: 48 hours
Glucose infusion 1000mL
Proportion of patients who received more than 1000 mL of 10% glucose solution (indicating tendency of hypoglycemia) between randomization and resolution of DKA or 48h after inclusion if DKA is unresolved
Measured: 48 hours
Glucose infusion of 30% glucose solution
Proportion of patients who received one perfusion of 30% glucose solution between randomization and resolution of DKA or 48h after inclusion if DKA is unresolved
Measured: 48 hours
Amount of glucose perfused
Amount of glucose perfused (in grams) (glucose 5%, 10% and 30%) between randomization and resolution of the DKA or 48 hours after inclusion if the DKA is not resolved
Measured: 48 hours
Potassium intake
Potassium intake (in grams) orally and intravenously between patient randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved
Measured: 48 hours
Length of stay in ICU
Duration of stay (in hours) in ICU
Measured: 48 hours
Time between patient randomization and resolution of DKA in T1D population
Time in hours between patient randomization and resolution of DKA in T1D population
Measured: 48 hours
Time between patient randomization and resolution of DKA in T2D population
Time in hours between patient randomization and resolution of DKA in T2D population
Measured: 48 hours
Time between patient randomization and resolution of DKA in patients suffering from first ketoacidosis episode
Time in hours between patient randomization and resolution of DKA in patients suffering from ketoacidosis
Measured: 48 hours
Episode of hypokalaemia in T1D population
Proportion of patients with at least one episode of hypokalaemia < 3.5 mmol/L between randomisation and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T1D population
Measured: 48 hours
Episode of hypokalaemia in T2D population
Proportion of patients with at least one episode of hypokalaemia < 3.5 mmol/L between randomisation and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T2D population
Measured: 48 hours
Episode of hypokalaemia in patients suffering from first ketoacidosis episode
Proportion of patients with at least one episode of hypokalaemia < 3.5 mmol/L between randomisation and resolution of DKA or 48 hours after inclusion if DKA is not resolved within inaugural ketoacidosis population
Measured: 48 hours
Episode of hypoglycaemia in T1D population
Proportion of patients with at least one episode of hypoglycaemia < 3.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T1D population
Measured: 48 hours
Episode of hypoglycaemia in T2D population
Proportion of patients with at least one episode of hypoglycaemia < 3.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T2D population
Measured: 48 hours
Episode of hypoglycaemia in patients suffering from first ketoacidosis episode
Proportion of patients with at least one episode of hypoglycaemia < 3.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within inaugural ketoacidosis population
Measured: 48 hours
Episode of severe hypoglycaemia in T1D population
Proportion of patients with at least one episode of severe hypoglycaemia < 2.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T1D population
Measured: 48 hours
Episode of severe hypoglycaemia in T2D population
Proportion of patients with at least one episode of severe hypoglycaemia < 2.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T2D population
Measured: 48 hours
Episode of severe hypoglycaemia in patients suffering from first ketoacidosis episode
Proportion of patients with at least one episode of severe hypoglycaemia < 2.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within inaugural ketoacidosis population
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start16 Aug 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
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 Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Roux, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443802
- Sponsor's protocol ID
- APHP210081
- Acronym
- LOSTINDIAB
- Status last verified
- May 2025
- First submitted
- 29 Jun 2022
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Low Dose to a Standard Dose of Insulin in Adult Diabetic Ketoacidosis in ICU to Reduce Metabolic Complications : a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05443802
- Acronym / sponsor ID
- LOSTINDIAB / APHP210081
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Diabetic ketoacidosis, Insulin deficiency, Hypoglycemia, Hypokalemia, Metabolic complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 5 Jul 2022 (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.
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss).
Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more a matter of insulin resistance than an absolute deficiency. However, international guidelines recommend a similar dose of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.
During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.
The research hypothesis is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.
Detailed description
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria which leads to major losses of water, sodium and potassium as well as the generation of metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss and acidosis).
Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more insulin resistance than absolute deficiency. However, international guidelines recommend a similar dosage of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.
During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.
A British study reported 27.6% hypoglycaemia and 55% hypokalemia during the first 24 hours of treatment. Comparable figures were observed by conducting a multicenter retrospective study of 122 patients: hypokalaemia and hypoglycaemia were observed in nearly two thirds of cases.
A pediatric study showed that a lower dose of insulin (0.05 IU/kg/h) reduced the rate of hypoglycaemia (20% vs 4%) and hypokalaemia (48% vs 20%) compared to at the standard dose (0.10 IU/kg/h) without modifying the time to resolution. But the very small number (25 children per arm), the questionable statistical analysis and the pediatric population (T1D only) do not make it possible to anticipate the potential benefit in a much more heterogeneous adult population.
The hypothesis of the research is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Insulin 0.05 IU/kg/hReduced dose of rapid-acting insulin of 0.05 IU/kg/h from randomization until resolution of DKA |
| Control | Other | Drug: Insulin 0.10 IU/kg/hRapid-acting insulin dose of 0.10 IU/kg/h in accordance with usual recommendations until resolution of DKA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged 18 years or above
- Admission in Intense/Intermediate Care Unit
- Severe DKA due to all types of diabetes (T1D, T2D and secondary diabetes and inaugural ketoacidosis) defined by association of the following 3 parameters:
- glucose > 11 mmol/L or affirmation of having diabetes
- ketonemia > 3mmol/L or ketonuria ≥ 2
Key exclusion criteria (12 listed)
- Non-diabetic ketoacidosis (fasting or alcoholic)
- Patient weighing less than 30 kg
- Hypokalemia < 3.5 mmol/L at the time of inclusion
- Hyperosmolar hyperglycemic state (defined as efficient plasma osmolarity > 320 mosmol/L)
- Absence of social security coverage
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 0.05 IU/kg/hIn the experimental arm, the patients will be given an insulin dose of 0.05 IU/kg/h. | Drug | Experimental |
| Insulin 0.10 IU/kg/hIn the control arm, patients will receive an insulin dose of 0.10 IU/kg/h. | Drug | Control |
Primary outcome
Metabolic complications
Time frame: 48 hours
Proportion of patients with metabolic complications (hypokalaemia <3.5 mmol/L and/or hypoglycemia <3.9 mmol/L) treated with a reduced dose of insulin (0.05 IU/kg/h) compared with the control group receiving the 0.10 IU/kg/h dose.
22 secondary outcomes
Resolution of diabetic ketoacidosis
Time frame: 48 hours
Episode of hypokalaemia
Time frame: 48 hours
Episode of hypoglycemia
Time frame: 48 hours
Episode of severe hypoglycemia
Time frame: 48 hours
Cardiac arrythmia diagnosed by EKG
Time frame: 48 hours
Glucose infusion 1000mL
Time frame: 48 hours
Glucose infusion of 30% glucose solution
Time frame: 48 hours
Amount of glucose perfused
Time frame: 48 hours
Potassium intake
Time frame: 48 hours
Length of stay in ICU
Time frame: 48 hours
Time between patient randomization and resolution of DKA in T1D population
Time frame: 48 hours
Time between patient randomization and resolution of DKA in T2D population
Time frame: 48 hours
Time between patient randomization and resolution of DKA in patients suffering from first ketoacidosis episode
Time frame: 48 hours
Episode of hypokalaemia in T1D population
Time frame: 48 hours
Episode of hypokalaemia in T2D population
Time frame: 48 hours
Episode of hypokalaemia in patients suffering from first ketoacidosis episode
Time frame: 48 hours
Episode of hypoglycaemia in T1D population
Time frame: 48 hours
Episode of hypoglycaemia in T2D population
Time frame: 48 hours
Episode of hypoglycaemia in patients suffering from first ketoacidosis episode
Time frame: 48 hours
Episode of severe hypoglycaemia in T1D population
Time frame: 48 hours
Episode of severe hypoglycaemia in T2D population
Time frame: 48 hours
Episode of severe hypoglycaemia in patients suffering from first ketoacidosis episode
Time frame: 48 hours
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 29 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Damien Roux, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 0.05 IU/kg/h and Insulin 0.10 IU/kg/h in people with Diabetic Ketoacidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 12 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 29 May 2025. 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 France. 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?
Metabolic complications (time frame: 48 hours). 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 29 May 2025.