Type 1 DiabetesNCT01308164
MD Logic Pump Advisor -Pediatric Study
A study testing MD Logic Pump Advisor in people with Type 1 Diabetes, run by Rabin Medical Center at 2 sites in 2 countries.
Trial summary
The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- MD Logic Pump Advisor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2011to Jan 2017
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject with Type 1 diabetes (> 1yr since diagnosis)
- Medetronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII(continuous subcutaneous insulin infusion)therapy for at least 3 months
- Age 10-18 years old
- HbA1c at inclusion ≥ 6.0%
- No concomitant diseases that influence metabolic control
- No current use of CGM
- Subjects do not participate in any other interventional study
- Subject measures SMBG(self-monitoring of blood glucose)at least 4 times a day (before meals and bedtime)
Who cannot join
- Known or suspected allergy to trial products
- Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
- Subject is currently using CGM device
- Diabetic ketoacidosis in the past 1 month
- Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Subject is participating in another drug or device study that could affect glucose measurements or glucose management
- Female subject who is pregnant or planning to become pregnant within the planned study duration
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of Automated-Insulin Pump Setting Using the MD-Logic Pump Advisor -Minors Sub Study
The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.
Study design:
Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be initiated after the pilot segment (including data analysis). The pilot segment will include 15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and 55 adults under a separate protocol)eligible subjects will be enrolled to allow for 92 valuable subjects at the end of the study. The subject population will be randomly assigned 1:1 to either the intervention group or control group. At this pediatric sub study approximately 50 patients will participate and at the separate Adults study additional 55 adult patients will participate.
Read the detailed description
the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as input, sensor readings, insulin delivery and recording of the meals during home care. During collection of the data, the patients are asked to continue their daily routine (no need for special consideration).
The present study was designed to test the automatic algorithm that will evaluate and change, when necessary, the patient's insulin pump settings based on prior sensor reading, insulin delivery, and meals data that was collected while the patient is under his regular treatment at home.
The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.
Study design:
Prospective study with two segments: (i) Pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be initiated after the pilot segment (including data analysis). The pilot segment will include 15-30 pediatric patients. In the RCT segment, up to 105(50 minors under this protocol and 55 adults under a separate protocol) eligible subjects will be enrolled to allow for 92 valuable subjects at the end of the study. The subject population will be randomly assigned 1:1 to either the intervention group or control group. At this pediatric sub study approximately 50 patients will participate and at the separate Adults study additional 55 adult patients will participate.
- Conditions
- Type 1 Diabetes
- Being tested
- MD Logic Pump Advisor
- Keywords
- Type 1 diabetes, Insulin Pump Therapy
- 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 Logic Pump AdvisorDevice
Insulin pump setting (i.e basal plan, correction factor, carbohydrate ratio and insulin activity time)will be adjusted using the MD-LOgic Pump Advisor
| Study group | Role | What they receive |
|---|---|---|
| MD logic Pump Advisor | Experimental | Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the MD-Logic Pump Advisor Receives: Device: MD Logic Pump Advisor |
| Control Group | No intervention | Regular treatment, no change will be made in the insulin pump setting during the study (unless there is a medical need or any safety concern) Only segment 2 of the study, which is conducted as RCT (randomized controlled trial) , will include control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in the normal range
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
Measured: Day 40
Secondary outcomes (9)
Number of iterations required to achieve the maximal time spent in the normal range
number of iterations required to achieve the maximal time spent in the normal range
Measured: day 40
Time spent above glucose level of 180 mg/dl
time spent above glucose level of 180 mg/dl
Measured: day 40
Time spent below glucose level of 70 mg/dl
time spent below glucose level of 70 mg/dl
Measured: day 40
Number of hypoglycemic events below glucose value of 63 mg/dl
Number of hypoglycemic events below glucose value of 63 mg/dl
Measured: day 40
Adverse event
adverse event
Measured: day 40
Glucose variability
glucose variability
Measured: day 40
Quality of life questionaire
quality of life questionaire
Measured: day 40
Number of recommendations the physician would not institute
number of MD Logic Pump Advisor recommendations the physician would not institute
Measured: day 40
Number of recommendations for changes in setting per patient and per iPRO wear
Number of recommendations for changes in setting per patient and per iPRO wear
Measured: day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2017
- Study completionJan 2017
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Schenider Children's Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308164
- Sponsor's protocol ID
- rmc005814ctil
- Status last verified
- Jan 2017
- First submitted
- 28 Feb 2011
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Automated-Insulin Pump Setting Using the MD-Logic Pump Advisor -Minors Sub Study
- ClinicalTrials.gov ID
- NCT01308164
- Acronym / sponsor ID
- rmc005814ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Insulin Pump Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Mar 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Mar 2011 (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 objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.
Study design:
Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be initiated after the pilot segment (including data analysis). The pilot segment will include 15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and 55 adults under a separate protocol)eligible subjects will be enrolled to allow for 92 valuable subjects at the end of the study. The subject population will be randomly assigned 1:1 to either the intervention group or control group. At this pediatric sub study approximately 50 patients will participate and at the separate Adults study additional 55 adult patients will participate.
Detailed description
the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as input, sensor readings, insulin delivery and recording of the meals during home care. During collection of the data, the patients are asked to continue their daily routine (no need for special consideration).
The present study was designed to test the automatic algorithm that will evaluate and change, when necessary, the patient's insulin pump settings based on prior sensor reading, insulin delivery, and meals data that was collected while the patient is under his regular treatment at home.
The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.
Study design:
Prospective study with two segments: (i) Pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be initiated after the pilot segment (including data analysis). The pilot segment will include 15-30 pediatric patients. In the RCT segment, up to 105(50 minors under this protocol and 55 adults under a separate protocol) eligible subjects will be enrolled to allow for 92 valuable subjects at the end of the study. The subject population will be randomly assigned 1:1 to either the intervention group or control group. At this pediatric sub study approximately 50 patients will participate and at the separate Adults study additional 55 adult patients will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD logic Pump Advisor | Experimental | Device: MD Logic Pump AdvisorInsulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the MD-Logic Pump Advisor |
| Control Group | No intervention | –Regular treatment, no change will be made in the insulin pump setting during the study (unless there is a medical need or any safety concern) Only segment 2 of the study, which is conducted as RCT (randomized controlled trial) , will include control group |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Subject with Type 1 diabetes (> 1yr since diagnosis)
- Medetronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII(continuous subcutaneous insulin infusion)therapy for at least 3 months
- Age 10-18 years old
- HbA1c at inclusion ≥ 6.0%
- No concomitant diseases that influence metabolic control
Key exclusion criteria (8 listed)
- Known or suspected allergy to trial products
- Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
- Subject is currently using CGM device
- Diabetic ketoacidosis in the past 1 month
- Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
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 Logic Pump AdvisorInsulin pump setting (i.e basal plan, correction factor, carbohydrate ratio and insulin activity time)will be adjusted using the MD-LOgic Pump Advisor | Device | MD logic Pump Advisor |
Primary outcome
Time spent in the normal range
Time frame: Day 40
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
9 secondary outcomes
Number of iterations required to achieve the maximal time spent in the normal range
Time frame: day 40
Time spent above glucose level of 180 mg/dl
Time frame: day 40
Time spent below glucose level of 70 mg/dl
Time frame: day 40
Number of hypoglycemic events below glucose value of 63 mg/dl
Time frame: day 40
Adverse event
Time frame: day 40
Glucose variability
Time frame: day 40
Quality of life questionaire
Time frame: day 40
Number of recommendations the physician would not institute
Time frame: day 40
Number of recommendations for changes in setting per patient and per iPRO wear
Time frame: day 40
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 11 Jan 2017.
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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.
Moshe Phillip, Prof principal investigator
Schenider Children's Medical
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD Logic Pump Advisor in people with Type 1 Diabetes, run by Rabin Medical Center at 2 sites in 2 countries.
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 8 inclusion and 8 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Slovenia. 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?
Time spent in the normal range (time frame: Day 40). 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 11 Jan 2017.