Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes

NCT03414320 | Completed

• 1 other identifier: BolusCalc
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The adoption of bolus calculators has been limited by the slow speed of the current trial and error approach. The goal of this project is to automate the determination of patient specific insulin pump parameters based on current automatic electronic logbooks of glucose measurements, carbohydrate intake, and insulin usage, by means of a mathematical model. More specifically, the investigators are interested in computing the carbohydrate to insulin ratio (CIR) and insulin sensitivity factor (ISF), which are the main parameters of bolus calculators. The present study is a proof-of-concept, open label, single arm clinical trial to validate the new method and refine both the mathematical model and the numerical techniques in well-regulated and disciplined type 1 diabetic subject. The study is a "trial" of the selected underlying mathematical model and the associated algorithms to simulate the glucose values of a patient with uncertain meal-data.

Conditions

Type1 Diabetes Mellitus

Keywords

type 1 diabetes; insulin pump; bolus calculator; continuous glucose monitoring; carbohydrate to insulin ratio; insulin sensitivity factor

Outcome Measures

Primary Outcomes (1)

• Accepting mathematical model

  The primary outcome measure will be to accept or reject the mathematical model by calculating mean-squared error differences with the data.

  three weeks

Study Arms (1)

Study Arm

EXPERIMENTAL

We will gather data from this group of patients.

Other: Gathering data

Interventions

Gathering data OTHER

Gathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals.

Study Arm

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Patient followed at the endocrinology department of UZ Leuven
• Type 1 diabetes
• Treated with subcutaneous insulin pump (CSII) for more than 12 weeks
• Using a continuous glucose monitor (CGM) for more than 12 weeks
• No known diabetic gastroparesis
• C-peptide negative
• HbA1c between 6-10%
• Using, or willing to use, the bolus calculator

You may not qualify if:

• Type 2 diabetes, patients with secondary diabetes
• Known diabetic gastroparesis
• C-peptide positive
• HbA1c \< 6% or \> 10%
• Not using or not willing to use the bolus calculator

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: proof-of-concept, open label, single arm

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 29, 2018
• Study Start: January 11, 2018
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-08

Locations

BE (1)