Insulin Dosing Calculator for Type 2 Diabetes

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

85 Participants Needed

Trial Summary

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 data supports the idea that Insulin Dosing Calculator for Type 2 Diabetes is an effective treatment?

The available research shows that insulin dosing calculators are effective in improving blood sugar control and patient safety. For example, one study found that integrating an insulin calculator into hospital systems helped improve patient care by ensuring timely insulin administration and better matching insulin doses with meals. Another study highlighted that these calculators are useful in managing insulin doses for patients after cardiac surgery, suggesting they help maintain stable blood sugar levels. Overall, these tools help reduce human error in insulin dosing, making them a reliable option for managing diabetes. ^{1 2 3 4 5}

What safety data exists for the insulin dosing calculator for type 2 diabetes?

The safety data for insulin dosing calculators, including those used in different settings, suggest they improve patient safety and glycemic control. Studies have shown that these calculators, when integrated into electronic health records, help reduce errors in insulin dosing by providing a structured approach to dose calculation. They have been used effectively in both pediatric and adult hospital settings, with benefits such as improved patient education and workflow. However, challenges in implementation and integration have been noted, which require careful management to avoid potential pitfalls. ^{1 2 3 6 7}

Is the Insulin Dosing Calculator for Type 2 Diabetes a promising treatment?

Yes, the Insulin Dosing Calculator for Type 2 Diabetes is a promising treatment. It helps doctors and patients manage insulin doses more accurately, reducing the chance of errors. This tool can improve patient care by making it easier to adjust insulin levels based on individual needs and food intake. It also integrates with electronic health records, making it convenient for hospital use. ^{1 3 4 8 9}

What is the purpose of this trial?

The goal of this feasibility trial is to test whether a novel insulin dosing calculator can improve blood glucose management for patients with type 2 diabetes mellitus on hospital admission. The main questions it aims to answer are: * Whether using this calculator leads to no excessive hypoglycemia? * Whether using this calculator leads to a decrease of hyperglycemia? Participants will receive initial insulin doses by the calculator on hospital admission, and the rest of care will follow standard of care. Participants will be compared with patients in the UW observational cohort who received initial insulin doses by standard of care.

Research Team

Hou-Hsien Chiang, MD, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving Hospital Glucometrics, Workflow, and Outcomes with a Computerized Intravenous Insulin Dose Calculator Built into the Electronic Health Record. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Insulin Bolus Calculator: Lessons Learned from Institutional Experience. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Insulin Bolus Calculator in a Pediatric Hospital. Safety and User Perceptions. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Netherlands 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. [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

A simple computer program for insulin dose adjustment in diabetic patients. [2019]

7. England 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. [2023]

8. United States 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Glucose control in critical illness using a web-based insulin dose calculator. [2011]