Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis

Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02006342

Acronym

GT-COG

Enrollment

Registered

2013-12-10

Start date

2012-11-30

Completion date

2013-04-30

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ketoacidosis

Keywords

Diabetes Mellitus, Diabetic Ketoacidosis, Insulin Glargine, Anion gap, Metabolic acidosis

Brief summary

To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).

Interventions

DRUGInsulin Glargine

DRUGRegular Insulin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \>18 years * Blood Glucose \>200 * potential of hydrogen (pH) \< 7.3 * Bicarbonate \< 18 * Ketonemia or Ketonuria * Anion Gap \> or = 16

Exclusion criteria

* Age \< 18 years * Pregnant * End state renal disease (ESRD) * Prisoners * Patients in shock or requiring emergency surgery * Those unwilling to consent for the trial * Allergic to Insulin Glargine

Design outcomes

Primary

Measure	Time frame	Description
Time to Anion Gap Closure	Participants monitored from hospital admission to discharge, an average of 4 days	Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.

Secondary

Measure	Time frame	Description
Number of Participants Admitted to the ICU	Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours	The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis.
Intensive Care Unit Length of Stay	Participants monitored from hospital admission to discharge, an average of 4 days	Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients.
Hospital Length of Stay	Participants monitored from hospital admission to discharge, an average of 4 days	Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis.
Number of Participants Who Developed Hypoglycemia	Participants monitored during the 24 hours after anion gap closure	To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure. Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Insulin Glargine Plus Regular Insulin Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis. Insulin Glargine Regular Insulin	20
Control - Regular Insulin Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring. Regular Insulin	20
Total	40

Baseline characteristics

Characteristic	Insulin Glargine Plus Regular Insulin	Control - Regular Insulin	Total
Age, Continuous	38.5 years	41.5 years	41 years
Region of Enrollment United States	20 participants	20 participants	40 participants
Sex: Female, Male Female	6 Participants	10 Participants	16 Participants
Sex: Female, Male Male	14 Participants	10 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2 / 20	3 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

Primary

Time to Anion Gap Closure

Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.

Time frame: Participants monitored from hospital admission to discharge, an average of 4 days