Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
ID06810596

Comparing Glycemic Control Efficacy Between The National Health System and Suez Canal University Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU

Led by Suez Canal University · Updated on 2025-02-05

100

Participants Needed

1

Research Sites

6 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two protocols for intravenous insulin infusion to improve blood sugar control in diabetic critically ill adults admitted to intensive care units at Suez Canal University (SCU) hospitals. The study aims to find out whether the SCU protocol is more effective than the National Health System (NHS) protocol used in the UK for managing blood glucose levels in these patients. This comparison will help determine the best way to control blood sugar in critically ill diabetic adults. Participants will be randomly assigned to one of two groups: one group will follow the SCU insulin infusion protocol, while the other will follow the NHS protocol. Both groups will receive regular insulin through an intravenous infusion, with doses adjusted according to their assigned protocol and blood sugar levels. Nurses will prepare and monitor the insulin infusion carefully, stopping it if blood sugar falls below 80 mg/dl. Potassium levels will be regularly checked and managed based on specific guidelines during the study. During the study, patients will have routine blood tests, including daily checks and more frequent potassium monitoring if needed. Researchers will collect information on their medical history, nutrition, mechanical ventilation duration, and any complications like diabetic ketoacidosis or hypoglycemia. Outcomes such as time to reach target blood glucose, ventilator-free days, ICU and hospital stay lengths, and mortality rates will be evaluated. The study will last up to 28 days, with ongoing assessments to monitor patients' progress and safety.

CONDITIONS

Brief Title

Comparing Efficacy Between Two Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to hospital with a potentially life-threatening condition (critically ill patients) with HbA1C greater than 6.0
Not Eligible

You will not qualify if you...

  • Patients with diabetic ketoacidosis (DKA)
  • Pregnant or breastfeeding patients
  • Patients with hyperosmolar non-ketotic coma

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 28 days

Participants receive intravenous insulin infusion according to one of two protocols for glycemic control while in the ICU.

Daily monitoring and adjustments during ICU stay

Follow-up

Duration - Up to 30 days

Participants are monitored for outcomes including ventilator-free days, ICU and hospital stay duration, and mortality for up to 30 days after treatment.

1 to 2 visits after ICU discharge depending on patient status

Trial Site Locations

Total: 1 location

1

Suez Canal University Hospitals

Ismailia, Egypt, 41522

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Research Team

A

Aiman A. Al-Touny, MD

M

Mohamed E. Abdel Ghaffar, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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