Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis
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ClinicalTrials.gov Identifier: NCT06007508 |
Recruitment Status :
Terminated
(Study intervention was adopted as standard of care.)
First Posted : August 23, 2023
Last Update Posted : January 25, 2024
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Condition or disease | Intervention/treatment | Phase |
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DKA | Drug: Insulin Glargine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This will be a two arm, prospective, randomized, open label trial in patients presenting with DKA. Block randomization will be used to ensure equal group sizes. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis |
Actual Study Start Date : | May 31, 2022 |
Actual Primary Completion Date : | February 28, 2023 |
Actual Study Completion Date : | February 28, 2023 |
Arm | Intervention/treatment |
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No Intervention: Standard of Care
Subjects presenting to ED with diagnosis of DKA and receiving intravenous short acting insulin will not have orders for subcutaneous insulin glargine placed for research purposes.
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Active Comparator: Intervention
Subjects presenting to ED with diagnosis of DKA will receive study medication set to begin within 2 hours after initiation of the IV insulin infusion. The dose will come from IV pharmacy and dispensed in a 1 mL insulin syringe. If the patient was not taking basal insulin prior to admission, the patient will receive 0.2 units/kg insulin glargine. If the patient was taking basal insulin prior to admission, the patient will receive their home insulin glargine dose.
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Drug: Insulin Glargine
Long-acting insulin
Other Names:
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- Does early administration of insulin glargine result in a change in ICU length of stay when compared to usual care for the treatment of diabetic ketoacidosis? [ Time Frame: Assessed from time of intervention until discharge from ICU to general medical unit or from hospital, up to 12 weeks ]Hypothesis: Early administration of insulin glargine will result in shorter ICU length of stay when compared to usual care in patients with DKA.
- Does early administration of insulin glargine result in a change in hospital length of stay (defined as time between start of insulin infusion and discharge from hospital) when compared to usual care for the treatment of diabetic ketoacidosis? [ Time Frame: Until discharge from ICU to general medical unit or from hospital, up to 12 weeks ]Hypothesis: Early administration of insulin glargine will result in shorter hospital length of stay when compared to usual care in patients with DKA.
- Does early administration of insulin glargine result in a change in recovery from DKA when compared to usual care for the treatment of diabetic ketoacidosis? [ Time Frame: Until discharge from ICU to general medical unit or from hospital, up to 12 weeks ]Recovery defined as blood glucose < 200 and two of: Anion Gap </= 12, Serum Bicarbonate ≥ 15 mEq/L, or pH > 7.3
- Does early administration of insulin glargine result in a change in duration of time on IV insulin infusion when compared to usual care for the treatment of diabetic ketoacidosis? [ Time Frame: Until discharge from ICU to general medical unit or from hospital, up to 12 weeks ]Hypothesis: Early administration of insulin glargine will result in a shorter duration of time on IV insulin infusion when compared to usual care for the treatment of diabetic ketoacidosis.
- Does early administration of insulin glargine result in a change in prevalence of rebound hyperglycemia when compared to usual care for the treatment of diabetic ketoacidosis? [ Time Frame: Through 24 hour mark after IV insulin discontinuation ]Rebound hypoglycemia defined as blood glucose > 180 mg/dL in the 24 hours after IV insulin infusion discontinuation
- The number of hypoglycemic (defined as blood glucose < 70mg/dL) events occurring while on IV insulin therapy or in the 24h hours after IV insulin infusion discontinuation with early insulin glargine administration compared to usual care [ Time Frame: Assessed from time of hospitalization until 24 hour mark after IV insulin discontinuation ]Hypothesis: The occurrence of a hypoglycemic event occurring while on IV insulin therapy or in the 24h hours after IV insulin infusion discontinuation with administration of insulin glargine is comparable to usual care.
- The change in mean blood glucose values in the 24 hours and (separately) 48 hours after IV insulin infusion discontinuation [ Time Frame: Assessed from time of hospitalization until 48 hour mark after IV insulin discontinuation ]Hypothesis: Early administration of insulin glargine will result in a lower mean value of blood glucose in the 24 and 48 hours after IV insulin infusion discontinuation.
- The change in duration of elevated anion gap when compared to usual care [ Time Frame: Until discharge from ICU to general medical unit or from hospital, up to 12 weeks ]Hypothesis: Early administration of insulin glargine will result in a shorter duration of elevated anion gap (defined as time with anion gap > 12) when compared to usual care for the treatment of diabetic ketoacidosis.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Presented to Regions Hospital ED for chief complaint of DKA, nausea, vomiting, abdominal pain, hyperglycemia, or similar
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Meets all below diagnostic criteria for DKA per the American Diabetes Association:
- Arterial or venous pH </= 7.3
- Serum Bicarbonate </= 18 mEq/L
- Ketonuria or ketonemia
- Anion Gap > 10
- Blood sugar > 250 mg/dL
- Receiving IV insulin infusion
- It is feasible to provide insulin glargine within 2 hours (+/- 30 minutes) of IV infusion start
- Will be admitted to the ICU for DKA, or already admitted to the ICU for DKA
- Ability to provide informed consent
Exclusion Criteria:
- Age < 18
- End stage renal disease or hepatic disease
- Hypotension requiring IV vasopressors or inotropes at any point during admission (i.e. norepinephrine, dobutamine, vasopressin, etc.)
- Need for emergent surgery
- Pregnant patients
- Prisoners
- Indication for insulin therapy other than DKA (hypertriglyceridemia, beta-blocker overdose, hyperglycemia without DKA)
- Patients receiving prior to admission insulin pump therapy
- Patients receiving prior to admission combination insulin products (i.e. Novolin® 70/30, Novolog® 70/30, Humalog® 75/25, etc.)
- Did not consent to study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06007508
United States, Minnesota | |
Regions Hospital | |
Saint Paul, Minnesota, United States, 55101 |
Principal Investigator: | Adis Keric, PharmD | Regions Hospital |
Documents provided by HealthPartners Institute:
Responsible Party: | HealthPartners Institute |
ClinicalTrials.gov Identifier: | NCT06007508 |
Other Study ID Numbers: |
X1935200 |
First Posted: | August 23, 2023 Key Record Dates |
Last Update Posted: | January 25, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to share IPD with investigators not currently involved in the study. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
DKA Hypoglycemia Rebound Hyperglycemia Type 1 Diabetes Type 2 Diabetes |
Ketosis Diabetic Ketoacidosis Acidosis Acid-Base Imbalance Metabolic Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Insulin Glargine Hypoglycemic Agents Physiological Effects of Drugs |