Type 1 DiabetesNCT01901913
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
A study testing MD-bolus calculator for pre-meal bolus and No MD-bolus calculator for pre-meal bolus in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- MD-bolus calculator for pre-meal bolus and No MD-bolus calculator for pre-meal bolus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Apr 2015
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diabetes type 1
- Age 14-25 years
- ->1yr since diagnosis
- Insulin infusion pump therapy for at least 3 months
- HbA1c at inclusion ≤10%
- BMI < 95th percentile for age and sex
- Patients willing to follow study instructions
Who cannot join
- Any condition that influence intestinal absorption or motility such as diabetic gastroparesis, celiac disease or malabsorptive states that could affect postprandial glucose absorption.
- any episode of diabetic ketoacidosis within the month prior to study entry and/or severe hypoglycaemia resulting in seizure or loss of consciousness in the month prior to enrolment
- any concomitant disease that may influence metabolic control
- participation in any other interventional study
- known or suspected allergy to trial products
- any significant diseases (such as preexisting seizures or epilepsy) or conditions including psychiatric disorders, eating disorder and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
- Female subject who is pregnant or planning to become pregnant within the planned study duration.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Schneider Children's Medical Center
Petah Tikva, Petah-Tikva, 49202
About this study
The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. In the current study we aim to optimize post-prandial closed-loop glycemic control by developing an automated MD-bolus calculator and to evaluate its safety and efficacy in controlling postprandial blood glucose when used together with the MD-Logic artificial pancreas system in type 1 diabetes patients.
The study will consist of a pilot study with two segments and a main study segment. The aim of each segment is detailed below:
- Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop operation with no meal announcement.
- Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to test the optimal distribution of insulin delivery during the meal.
- Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we will use the results and conclusions from the previous two pilot segments to develop the MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this automated insulin bolus calculator will be tested in a randomized cross-over study that will compare postprandial glycemic control under MDLAP with and without the use of the MD-Bolus Calculator.
- Conditions
- Type 1 Diabetes
- Being tested
- MD-bolus calculator for pre-meal bolus, No MD-bolus calculator for pre-meal bolus
- Keywords
- Type 1 Diabetes, Artificial pancreas, Closed loop
- 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.
MD-bolus calculator for pre-meal bolusDevice
No MD-bolus calculator for pre-meal bolusDevice
| Study group | Role | What they receive |
|---|---|---|
| MD-bolus calculator for pre meal bolus | Experimental | closed loop session with MD-bolus calculator for pre-meal bolus. Receives: Device: MD-bolus calculator for pre-meal bolus |
| No MD-bolus calculator for pre-meal bolus | Active comparator | closed loop session without MD-bolus calculator for pre-meal bolus Receives: Device: No MD-bolus calculator for pre-meal bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve above 180 mg/dl (10 mmol/l)
Measured: 4 hours postprandial
Secondary outcomes (6)
Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal
Measured: 4 hours postprandial
The incremental glucose rise from premeal to peak postprandial level
Measured: 4 hours postprandial
Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l)
Measured: 4 hours postprandial
The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial.
Measured: 4 hours postprandial
Percentage of time spent below 70 mg/dl (3.9mmol/l)
Measured: 4 hours postprandial
Percentage of time spent above 180, 250, (10, 13.9 mmol/l)
Measured: 4 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901913
- Sponsor's protocol ID
- rmc007418ctil
- Status last verified
- Nov 2014
- First submitted
- 9 Jul 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
- ClinicalTrials.gov ID
- NCT01901913
- Acronym / sponsor ID
- rmc007418ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Artificial pancreas, Closed loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Jul 2013 (estimated)
- 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 MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. In the current study we aim to optimize post-prandial closed-loop glycemic control by developing an automated MD-bolus calculator and to evaluate its safety and efficacy in controlling postprandial blood glucose when used together with the MD-Logic artificial pancreas system in type 1 diabetes patients.
The study will consist of a pilot study with two segments and a main study segment. The aim of each segment is detailed below:
- Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop operation with no meal announcement.
- Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to test the optimal distribution of insulin delivery during the meal.
- Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we will use the results and conclusions from the previous two pilot segments to develop the MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this automated insulin bolus calculator will be tested in a randomized cross-over study that will compare postprandial glycemic control under MDLAP with and without the use of the MD-Bolus Calculator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD-bolus calculator for pre meal bolus | Experimental | Device: MD-bolus calculator for pre-meal bolusclosed loop session with MD-bolus calculator for pre-meal bolus. |
| No MD-bolus calculator for pre-meal bolus | Active comparator | Device: No MD-bolus calculator for pre-meal bolusclosed loop session without MD-bolus calculator for pre-meal bolus |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diabetes type 1
- Age 14-25 years
- ->1yr since diagnosis
- Insulin infusion pump therapy for at least 3 months
- HbA1c at inclusion ≤10%
Key exclusion criteria (7 listed)
- Any condition that influence intestinal absorption or motility such as diabetic gastroparesis, celiac disease or malabsorptive states that could affect postprandial glucose absorption.
- any episode of diabetic ketoacidosis within the month prior to study entry and/or severe hypoglycaemia resulting in seizure or loss of consciousness in the month prior to enrolment
- any concomitant disease that may influence metabolic control
- participation in any other interventional study
- known or suspected allergy to trial products
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 |
|---|---|---|
| MD-bolus calculator for pre-meal bolus | Device | MD-bolus calculator for pre meal bolus |
| No MD-bolus calculator for pre-meal bolus | Device | No MD-bolus calculator for pre-meal bolus |
Primary outcome
Area under the curve above 180 mg/dl (10 mmol/l)
Time frame: 4 hours postprandial
6 secondary outcomes
Time within range of 70-180 mg/dl over 4 hours from the beginning of the meal
Time frame: 4 hours postprandial
The incremental glucose rise from premeal to peak postprandial level
Time frame: 4 hours postprandial
Number of hypoglycemic events below 70 mg/dl (3.9 mmol/l)
Time frame: 4 hours postprandial
The percentage of subjects who reached the desired glucose target (70-180 mg/dl) 4 hours postprandial.
Time frame: 4 hours postprandial
Percentage of time spent below 70 mg/dl (3.9mmol/l)
Time frame: 4 hours postprandial
Percentage of time spent above 180, 250, (10, 13.9 mmol/l)
Time frame: 4 hours postprandial
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 16 Apr 2015.
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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 MD-bolus calculator for pre-meal bolus and No MD-bolus calculator for pre-meal bolus in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
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 7 inclusion and 7 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 16 Apr 2015. 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 Israel. 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?
Area under the curve above 180 mg/dl (10 mmol/l) (time frame: 4 hours postprandial). 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 16 Apr 2015.