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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Insulin Glargine 300 UNT/ML [Toujeo]
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycaemic Crisis in Diabetes Mellitus focused on measuring hyperglycemic crisis, DKA, HHS, insulin pump, basal insulin, critical care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhua Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

basal insulin and insulin pump

insulin pump

Arm Description

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.

Patients in the control group did not receive placebo injections.

Outcomes

Primary Outcome Measures

the rates of rebound hyperglycemia
the rates of hyperglycemia( serum glucose >300mg/dl) after ceasing insulin infusion
the rates of hypoglycemia
the rates of hypoglycemia( serum glucose <70mg/dl) during insulin infusion

Secondary Outcome Measures

insulin infusion time
hours of the total insulin infusion therapeutic time
ICU length of stay
days of ICU admission
ventilator use days
days of ventilator depending time(from intubation to extubation)
ICU Mortality rate
mortality rate during ICU admission

Full Information

First Posted
July 27, 2021
Last Updated
March 8, 2022
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05155917
Brief Title
Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care
Official Title
Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycaemic Crisis in Diabetes Mellitus, Diabetic Ketoacidosis, Hyperglycaemic Hyperosmolar Nonketotic Syndrome
Keywords
hyperglycemic crisis, DKA, HHS, insulin pump, basal insulin, critical care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
basal insulin and insulin pump
Arm Type
Experimental
Arm Description
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.
Arm Title
insulin pump
Arm Type
No Intervention
Arm Description
Patients in the control group did not receive placebo injections.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine 300 UNT/ML [Toujeo]
Intervention Description
insulin glargine sc (0.25 U/kg body weight)
Primary Outcome Measure Information:
Title
the rates of rebound hyperglycemia
Description
the rates of hyperglycemia( serum glucose >300mg/dl) after ceasing insulin infusion
Time Frame
"the next 12 hours" after ceasing insulin infusion
Title
the rates of hypoglycemia
Description
the rates of hypoglycemia( serum glucose <70mg/dl) during insulin infusion
Time Frame
"the next 12 hours" after ceasing insulin infusion
Secondary Outcome Measure Information:
Title
insulin infusion time
Description
hours of the total insulin infusion therapeutic time
Time Frame
'the next 12 hours' after ceasing insulin infusion
Title
ICU length of stay
Description
days of ICU admission
Time Frame
through study completion, an average of 1 year
Title
ventilator use days
Description
days of ventilator depending time(from intubation to extubation)
Time Frame
through study completion, an average of 1 year
Title
ICU Mortality rate
Description
mortality rate during ICU admission
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YU FU LEE, college
Phone
886-4-7238595
Ext
3972
Email
181318@cch.org.tw
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua city
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YU FU LEE, college
Phone
+886-4-7238595
Ext
3972
Email
181318@cch.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25905280
Citation
Gosmanov AR, Gosmanova EO, Kitabchi AE. Hyperglycemic Crises: Diabetic Ketoacidosis and Hyperglycemic Hyperosmolar State. 2021 May 9. In: Feingold KR, Anawalt B, Blackman MR, Boyce A, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hofland J, Kalra S, Kaltsas G, Kapoor N, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, New M, Purnell J, Sahay R, Shah AS, Singer F, 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/
Results Reference
result
PubMed Identifier
31862758
Citation
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.
Results Reference
result
PubMed Identifier
17508198
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.
Results Reference
result
PubMed Identifier
22685233
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. doi: 10.1210/jc.2012-1244. Epub 2012 Jun 8.
Results Reference
result

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

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