Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes (POC-IDENTITY-1)
Primary Purpose
Type1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gathering data
Sponsored by
About this trial
This is an interventional other trial for Type1 Diabetes Mellitus focused on measuring type 1 diabetes, insulin pump, bolus calculator, continuous glucose monitoring, carbohydrate to insulin ratio, insulin sensitivity factor
Eligibility Criteria
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
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Arm
Arm Description
We will gather data from this group of patients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03414320
First Posted
January 12, 2018
Last Updated
August 1, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03414320
Brief Title
Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes
Acronym
POC-IDENTITY-1
Official Title
Proof of Concept Study for the Identification of Patient-specific Parameters for Bolus Calculators in Type 1 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
July 12, 2018 (Actual)
Study Completion Date
July 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes Mellitus
Keywords
type 1 diabetes, insulin pump, bolus calculator, continuous glucose monitoring, carbohydrate to insulin ratio, insulin sensitivity factor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
proof-of-concept, open label, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
We will gather data from this group of patients.
Intervention Type
Other
Intervention Name(s)
Gathering data
Intervention Description
Gathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals.
Primary Outcome Measure Information:
Title
Accepting mathematical model
Description
The primary outcome measure will be to accept or reject the mathematical model by calculating mean-squared error differences with the data.
Time Frame
three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes
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