Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes (POC-IDENTITY-1)

August 1, 2018 updated by: prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven

Proof of Concept Study for the Identification of Patient-specific Parameters for Bolus Calculators in Type 1 Diabetic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After signing informed consent and checking eligibility criteria participants will receive uniform education related to self-monitoring of blood glucose and continuous glucose monitoring (CGM) using the CGM sensor as well as on the bolus calculator (BC). The study will take three weeks (or three sensors) per patient.

Patients should live a close to normal life and should participate in their normal daily activities. During the study, patients must consequently keep using the BC of their insulin pump, record in the insulin pump when they eat extra food outside their regular meals and when they inject extra insulin without the use of their insulin pump. Faulty 'meal markers' have to be noted in a booklet and patients will also have to take pictures of their plate for each meal or record their meals in detail in a booklet. Patients should also consequently shut off insulin delivery when they disconnect their insulin pump and write it down in a booklet. The patients will be asked to wear an activity tracker (i.e. Fitbit), this data will help in the refinement of the model and will be used for research later in the same project.

During the study, patients must skip a total of three meals: breakfast, lunch and dinner (not on the same day, but within the three weeks). This gives the investigators a period of measurements in which they know that there are no significant amounts of unpredictable carbohydrates in the blood. Patients can give correction insulin or take extra fast carbohydrates to correct the glycaemia when needed and record this in the insulin pump or in a booklet. The fast rescue carbohydrates should be in the form of Dextro energy tablets (provided by the study team).

After the three weeks, patients will come back to the hospital where the study team will download data from the insulin pump, CGM sensor, and activity tracker. The booklet and photographs of the meals will be handed over to the study team. This is the end of the study for the patient. The collected patient data will further be used to assess the model fit of the chosen mathematical model as in, i.e. the investigators evaluate how well the model is able to reproduce the collected data.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Type 2 diabetes, patients with secondary diabetes
  • Patients treated with multiple daily insulin injections or begin of treatment with CSII less than 12 weeks before inclusion
  • Known diabetic gastroparesis
  • C-peptide positive
  • HbA1c < 6% or > 10%
  • Not using or not willing to use the bolus calculator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm
We will gather data from this group of patients.
Other: Gathering data
Gathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accepting mathematical model
Time Frame: three weeks
The primary outcome measure will be to accept or reject the mathematical model by calculating mean-squared error differences with the data.
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2018

Primary Completion (Actual)

July 12, 2018

Study Completion (Actual)

July 12, 2018

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BolusCalc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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