Insulin Dosing Calculator for Type 2 Diabetes

No longer recruiting at 2 trial locations

Overseen By Hou-Hsien Chiang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: Insulin

Disqualifiers: ICU admission, Elective surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to manage insulin doses for hospitalized patients with type 2 diabetes. The goal is to determine if this calculator can stabilize blood sugar levels without causing excessive low blood sugar events. Participants will receive initial insulin doses using this calculator, and their results will be compared to those who receive standard care. This trial suits individuals admitted to the University of Washington Medical Centers with type 2 diabetes who already use insulin at home. As an unphased trial, this study offers an opportunity to contribute to innovative improvements in diabetes care.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be receiving insulin therapy prior to admission, it seems likely that you will continue your current insulin regimen.

What prior data suggests that this insulin dosing calculator is safe for patients with type 2 diabetes?

Research shows that insulin dosing calculators can enhance patient safety and improve blood sugar management. Studies suggest these tools can prevent both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). They provide accurate insulin doses based on factors such as blood sugar levels and body weight, simplifying and improving insulin management. Although specific safety data for the calculator used in this trial is unavailable, previous calculators have demonstrated safety, with no major safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the insulin dosing calculator for Type 2 Diabetes because it offers a personalized approach to insulin management. Unlike traditional methods where dosing can be a trial-and-error process, this calculator aims to tailor insulin doses specifically to each individual's needs. This could lead to more precise glucose control and reduce the risk of both high and low blood sugar episodes. By streamlining the dosing process, it also has the potential to make diabetes management easier and more efficient for patients.

What evidence suggests that this insulin dosing calculator is effective for managing blood glucose in type 2 diabetes?

Research has shown that insulin dosing calculators can help people with type 2 diabetes control their blood sugar more effectively. In this trial, participants will use an insulin dosing calculator to manage their insulin levels. One study found that these tools help manage blood sugar levels and enhance patient safety. They also simplify determining the correct insulin dose, which is particularly beneficial in busy hospitals. Previous research suggests that using these calculators reduces both high and low blood sugar episodes, making them a promising option for better diabetes management during hospital stays. ^{1 2 3 6 7}

Who Is on the Research Team?

Hou-Hsien Chiang, MD, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for patients admitted to the University of Washington Medical Centers who have type 2 or steroid-induced diabetes mellitus and were on insulin therapy before admission. It's not suitable for individuals outside these criteria.

Inclusion Criteria

Patients who are admitted to University of Washington Medical Centers

I have type 2 diabetes or diabetes caused by steroids.

I was on insulin therapy before being admitted.

Exclusion Criteria

Patients who report low appetite (25% or less) on admission or have a significantly decreased level of consciousness that they unlikely eat right after admission

I am currently in the ICU or obstetrics ward.

I have had severe diabetes complications like DKA or needed IV insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive initial insulin doses by the calculator on hospital admission

48 hours

Inpatient hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Initial insulin dosing using the calculator

Trial Overview The study is testing a new insulin dosing calculator against standard care in managing blood sugar levels upon hospital admission. The aim is to see if it reduces high blood sugar without causing too much low blood sugar.

How Is the Trial Designed?

Group I: Insulin dosing calculator Experimental Treatment 1 Intervention

Initial insulin dosing using the calculator is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Insulin dosing calculator for:

• Type 2 diabetes mellitus

Approved in European Union as Insulin dosing calculator for:

• Type 2 diabetes mellitus

Approved in Canada as Insulin dosing calculator for:

• Type 2 diabetes mellitus

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The 'Walk with you' application for titrating basal insulin in hospitalized patients with type-2 diabetes significantly reduced fasting blood glucose (FBG) levels and helped more patients reach target FBG levels within 3 days compared to the standard adjustment regimen.

The application was found to be safe, with no significant difference in the incidence of hypoglycemia between the application group and the control group, making it a user-friendly and effective tool for managing insulin doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a basal insulin dose management smartphone application for controlling fasting blood glucose in patients with type-2 diabetes mellitus: A single-centre, randomised clinical study. Luo, E., Wan, J., Su, M., et al.[2023]

The Diabetics software combines a nutrition database with a bolus calculator to help patients manage their prandial insulin dosing more effectively, improving blood glucose control.

The software customizes insulin dosing based on carbohydrate intake and the effects of fat and protein, providing tailored recommendations for normal and square-wave boluses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bolus calculator with nutrition database software, a new concept of prandial insulin programming for pump users. Pańkowska, E., Błazik, M.[2021]

The implementation of a customized insulin bolus dose calculator for hospitalized pediatric patients did not increase the rates of hypoglycemia or severe hypoglycemia, indicating that it is a safe tool for managing insulin dosing.

User satisfaction with the insulin calculator tool was high, with physicians reporting slightly higher satisfaction than nurses, and a strong correlation was found between perceived quality of care improvement and overall satisfaction with the tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin Bolus Calculator in a Pediatric Hospital. Safety and User Perceptions. Ateya, MB., Aiyagari, R., Moran, C., et al.[2018]

A modified web-based insulin calculator was developed for critical care, allowing for better control of blood glucose levels by incorporating bolus doses and storing important patient data, which was tested on 661 ICU patients over a year.

The study found that the calculator effectively managed blood glucose without significant diurnal variation, suggesting that daily monitoring may be sufficient, while also reporting a low incidence of hypoglycemia during insulin infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose control in critical illness using a web-based insulin dose calculator. Laha, SK., Taylor, R., Collin, SA., et al.[2011]

The online intravenous insulin infusion calculator (IVIIC) was well accepted by over 80% of registered nurses (RNs), who found it easy to implement and effective in controlling blood glucose levels.

Approximately 82% of RNs expressed confidence in using the IVIIC, with most believing the training provided was adequate, indicating strong support for its use in managing hyperglycemia in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving hyperglycemia in the hospital: outcomes of a nursing in-service to evaluate acceptance of a web-based insulin infusion calculator. Hermayer, KL., Hushion, TV., Arnold, PC., et al.[2021]

The implementation of insulin bolus calculators in inpatient care has been shown to enhance glycemic control and improve patient safety, highlighting their efficacy in managing diabetes in hospital settings.

The integration process revealed several challenges, such as timing of insulin administration and variations in bolus calculations, but also provided benefits in patient education and streamlined care, emphasizing the importance of a multidisciplinary approach in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin Bolus Calculator: Lessons Learned from Institutional Experience. Nolt, VD., Araya, A., Ateya, MB., et al.[2021]

Computerized insulin dosing calculators significantly improved mean blood glucose levels and reduced the incidence of hypoglycemia in adult patients after cardiac surgery, based on a systematic review of five studies.

However, there was no significant difference in the time taken to reach target blood glucose levels or in the incidence of severe hypoglycemia when compared to traditional paper protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised insulin dosing calculators for the management of continuous insulin infusions after cardiac surgery: A systematic review and meta-analysis. Higgs, MH., Fernandez, RS.[2018]

The integration of an IV insulin calculator into the electronic health record in the cardiovascular intensive care unit (CVICU) improved glycemic control, with an increase in the percentage of blood sugar readings within the target range from 87.97% at baseline to around 91% at one to six months post-implementation.

The implementation also significantly reduced the incidence of severe hypoglycemia, with no blood sugar levels below 40 mg/dL recorded after the intervention, demonstrating enhanced safety in insulin management for critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Hospital Glucometrics, Workflow, and Outcomes with a Computerized Intravenous Insulin Dose Calculator Built into the Electronic Health Record. Shelden, D., Ateya, M., Jensen, A., et al.[2021]

A BASIC program was developed to help adjust insulin doses for diabetic patients, using data from seven glucose tests and previous insulin doses.

The program's recommendations for insulin adjustments were found to correlate well with the assessments made by four expert diabetologists, indicating its potential efficacy in managing diabetes treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple computer program for insulin dose adjustment in diabetic patients. Bellomo, G., Santucci, S., Mannino, D., et al.[2019]

Citations

1. diabetesjournals.org diabetesjournals.org/spectrum/article/38/3/249/163137/Inpatient-Insulin-Dosing-Calculators

Inpatient Insulin Dosing Calculators | Diabetes Spectrum Inpatient insulin calculators offer the potential to improve blood glucose management, simplify workflow, and address the growing demand for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40823595/

Inpatient Insulin Dosing Calculators Inpatient insulin calculators offer the potential to improve blood glucose management, simplify workflow, and address the growing demand for ...

3. lantus.com lantus.com/hcp/dosing-injection/insulin-dose-and-dosing-calculator

Insulin Dosing Calculator Learn how to calculate insulin dosage with the help of an interactive T2DM Lantus® dosing calculator based on weight. See Important Safety Information.

4. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-2024-a579b

Insulin Dosing Calculator for Type 2 Diabetes The available research shows that insulin dosing calculators are effective in improving blood sugar control and patient safety. For example, one study found ...

5. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.70012

Implementation of a novel insulin infusion calculator in the ... This multicenter cohort study aimed to evaluate the efficacy and safety of implementing an EHR medication administration record (MAR) calculator ...

6. hdsi.uchicago.edu hdsi.uchicago.edu/wp-content/uploads/2021/09/SHAABAN_IDC-poster-2021.9.1-SFS.pdf

An EMR-based Dose Calculator for Inpatient Insulin ... Rapid-acting insulin dosing is complex and dynamic, depending on multiple factors including current blood glucose (BG) and the anticipated carbohydrate ...

7. nationwidechildrens.org nationwidechildrens.org/specialties/diabetes-clinic/diabetes-calculator-for-kids

Diabetes Calculator for Kids The Diabetes Calculator for Kids is an electronic tool that calculates rapid acting insulin bolus dosage in 5 easy steps.