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

NCT05155917 | Unknown Phase 2

• 1 other identifier: 210201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hyperglycaemic Crisis in Diabetes Mellitus; Diabetic Ketoacidosis; Hyperglycaemic Hyperosmolar Nonketotic Syndrome

Keywords

hyperglycemic crisis; DKA; HHS; insulin pump; basal insulin; critical care

Outcome Measures

Primary Outcomes (2)

• 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

• the rates of hypoglycemia

  the rates of hypoglycemia( serum glucose \<70mg/dl) during insulin infusion

  "the next 12 hours" after ceasing insulin infusion

Secondary Outcomes (4)

• insulin infusion time

  'the next 12 hours' after ceasing insulin infusion

• ICU length of stay

  through study completion, an average of 1 year

• ventilator use days

  through study completion, an average of 1 year

• ICU Mortality rate

  through study completion, an average of 1 year

Study Arms (2)

basal insulin and insulin pump

EXPERIMENTAL

Subjects in the intervention group received insulin glargine sc (0.25 U/kg body weight) within 6 h of initiation of iv insulin infusion, as close to initiation of iv insulin as possible.

Drug: Insulin Glargine 300 UNT/ML [Toujeo]

insulin pump

NO INTERVENTION

Patients in the control group did not receive placebo injections.

Interventions

Insulin Glargine 300 UNT/ML [Toujeo] DRUG

insulin glargine sc (0.25 U/kg body weight)

basal insulin and insulin pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• pregnancy
• age under 18 years old

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

RECRUITING

Related Publications (4)

• Dhatariya K, Mustafa O, Stathi D. Hyperglycemic Crises. 2025 Jun 10. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK279052/

  PMID: 25905280 RESULT

• 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.

  PMID: 31862758 RESULT

• 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.

  PMID: 17508198 RESULT

• 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. doi: 10.1210/jc.2012-1244. Epub 2012 Jun 8.

  PMID: 22685233 RESULT

MeSH Terms

Conditions

Diabetic Ketoacidosis

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

YU FU LEE, college

CONTACT

886-4-7238595; 181318@cch.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: December 14, 2021
• Study Start: March 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 10, 2022

Record last verified: 2021-12

Locations

TW (1)