Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care

Diabetic Ketoacidosis Clinical Trial

Official title:

Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155917
• Other study ID #: 210201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2022
• Est. completion date: January 2024

Study information

• Verified date: December 2021
• Source: Changhua Christian Hospital
• Contact: YU FU LEE, college
• Phone: 886-4-7238595
• Email: 181318[@]cch.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown. We assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

Description:

Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are hyperglycemic crises sharing similar clinical features including hyperglycemia, dehydration and electrolytes abnormalities. Hyperglycemia results from relative deficient circulating insulin and oversecretion of glucagon, catecholamines, cortisol, and growth hormone. Glycosuria induced osmotic diuresis leads to dehydration and electrolyte abnormalities. Diabetic ketoacidosis is also characterized by increased gluconeogenesis, lipolysis, ketogenesis, and decreased glycolysis.[1] In critically ill and mentally obtunded patients with DKA or hyperosmolar hyperglycemia, continuous intravenous insulin is the standard of care.[2] Administration of subcutaneous insulin glargine during intravenous insulin infusion shortened the time of DKA correction and significantly decreased hyperglycemia after discontinuation of the intravenous insulin. [3, 4]The differences in rebound hyperglycemia rates were highly significant for at least 12 hours after transition to subcutaneous insulin regimens in the DKA and non-DKA patients as well as in organ transplant patients receiving steroids. [4] However, the previous studies only enrolled small numbers of patients(without Asian population) and excluded newly diagnosed hyperglycemia or critical illness and pregnant women. The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown. The investigators assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hyperglycemic crisis(DKA, HHS or mixing type) receiving iv insulin infusion
• Patients admitted to the Changhua Christian Hospital Medical Intensive Care Unit(MICU)

Exclusion Criteria:

• pregnancy
• age under 18 years old

Related Conditions & MeSH terms

• Diabetic Ketoacidosis
• Ketosis

Intervention

Drug:
• Insulin Glargine 300 UNT/ML [Toujeo]
insulin glargine sc (0.25 U/kg body weight)

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua city

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

American Diabetes Association. 15. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S193-S202. doi: 10.2337/dc20-S015. Review. — View Citation

Gosmanov AR, Gosmanova EO, Kitabchi AE. Hyperglycemic Crises: Diabetic Ketoacidosis and Hyperglycemic Hyperosmolar State. 2021 May 9. In: Feingold KR, Anawalt B, Boyce A, Chrousos G, de Herder WW, Dhatariya K, Dungan K, Hershman JM, Hofland J, Kalra S, Ka — View Citation

Hsia E, Seggelke S, Gibbs J, Hawkins RM, Cohlmia E, Rasouli N, Wang C, Kam I, Draznin B. Subcutaneous administration of glargine to diabetic patients receiving insulin infusion prevents rebound hyperglycemia. J Clin Endocrinol Metab. 2012 Sep;97(9):3132-7 — View Citation

Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rates of rebound hyperglycemia	the rates of hyperglycemia( serum glucose >300mg/dl) after ceasing insulin infusion	"the next 12 hours" after ceasing insulin infusion
Primary	the rates of hypoglycemia	the rates of hypoglycemia( serum glucose <70mg/dl) during insulin infusion	"the next 12 hours" after ceasing insulin infusion
Secondary	insulin infusion time	hours of the total insulin infusion therapeutic time	'the next 12 hours' after ceasing insulin infusion
Secondary	ICU length of stay	days of ICU admission	through study completion, an average of 1 year
Secondary	ventilator use days	days of ventilator depending time(from intubation to extubation)	through study completion, an average of 1 year
Secondary	ICU Mortality rate	mortality rate during ICU admission	through study completion, an average of 1 year