Type1 Diabetes MellitusPOC-IDENTITY-1NCT03414320
Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes
A study testing Gathering data in people with Type1 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Gathering data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Jan 2018to 12 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- C-peptide negative
- HbA1c between 6-10%
- Using, or willing to use, the bolus calculator
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Gathering data
- Keywords
- type 1 diabetes, insulin pump, bolus calculator, continuous glucose monitoring, carbohydrate to insulin ratio, insulin sensitivity factor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gathering dataOther
Gathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | We will gather data from this group of patients. Receives: Other: Gathering data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start11 Jan 2018
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- proof-of-concept, open label, single arm
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414320
- Sponsor's protocol ID
- BolusCalc
- Acronym
- POC-IDENTITY-1
- Status last verified
- Aug 2018
- First submitted
- 12 Jan 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study for the Identification of Patient-specific Parameters for Bolus Calculators in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03414320
- Acronym / sponsor ID
- POC-IDENTITY-1 / BolusCalc
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- type 1 diabetes, insulin pump, bolus calculator, continuous glucose monitoring, carbohydrate to insulin ratio, insulin sensitivity factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- proof-of-concept, open label, single arm
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Other: Gathering dataWe will gather data from this group of patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gathering dataGathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals. | Other | Study Arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gathering data in people with Type1 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accepting mathematical model (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.