Type 1 DiabetesNCT01157923
MD Logic Pump Advisor- Adults Study
A study testing MD Logic Pump Advisor in people with Type 1 Diabetes and Insulin Pump Therapy, run by Rabin Medical Center at 2 sites in 2 countries.
Trial summary
Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes. 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Insulin Pump Therapy
- 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
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2010to Jul 2016
- 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
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
- Age ≥ 18 years
- 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
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 3 months.
- 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 Settings Using the MD-Logic Pump Advisor-Adults Sub Study
Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.
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.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).
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.
The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).
Endpoints:
- Primary endpoint Increase in time spent in the normal range, defined as sensor glucose level within 70 to 180 mg/dl
- Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70 mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose variability, quality of life measurements and subject treatment satisfaction.
Inclusion Criteria:
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII (continuous subcutaneous insulin infusion) therapy for at least 3 months
- Age ≥ 18 years
- 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
- Conditions
- Type 1 Diabetes, Insulin Pump Therapy
- 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 settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
| Study group | Role | What they receive |
|---|---|---|
| intervantion group | Experimental | Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration 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). |
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: during each 6 days iteration
Secondary outcomes (9)
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Measured: Day 78
time spent above 180 mg/dl
time spent above 180 mg/dl
Measured: during each 6 days iteration
time spent below 70 mg/dl
time spent below 70 mg/dl
Measured: during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
Number of Hypoglycemic events below 63 mg/dl
Measured: during each 6 days iteration
Adverse event
Adverse event
Measured: during each 6 days iteration
glucose variability- area under the curve
glucose variability measured as area under the curve (the area between the measured blood glucose and the glucose level of 180 mg/dl) and area above the curve (the area between the measured blood glucose and the glucose level of 70 mg/dl
Measured: during each 6 days iteration
Quality of Life Questionaires
Quality of Life Questionaires
Measured: At the end of the study- day 30 -78
Number of MDLAP-recommendations that were rejected by the physician
Number of MDLAP-recommendations that were rejected by the physician
Measured: during each 6 days iteration
Number and type of changes in any pump setting per iteration
Number and type of changes in any pump setting per iteration
Measured: during each 6 days iteration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2016
- Study completionJul 2016
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
- 18 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
- NCT01157923
- Sponsor's protocol ID
- rmc005816ctil
- Status last verified
- Jan 2016
- First submitted
- 27 Jun 2010
- 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 Settings Using the MD-Logic Pump Advisor-Adults Sub Study
- ClinicalTrials.gov ID
- NCT01157923
- Acronym / sponsor ID
- rmc005816ctil
- Conditions
- Type 1 Diabetes, Insulin Pump Therapy
- Keywords
- Type 1 diabetes, Insulin Pump Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jul 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jul 2010 (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.
Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.
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.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).
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.
The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).
Endpoints:
- Primary endpoint Increase in time spent in the normal range, defined as sensor glucose level within 70 to 180 mg/dl
- Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70 mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose variability, quality of life measurements and subject treatment satisfaction.
Inclusion Criteria:
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII (continuous subcutaneous insulin infusion) therapy for at least 3 months
- Age ≥ 18 years
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervantion group | Experimental | Device: MD Logic Pump AdvisorInsulin pump settings (i.e., basal plan, correction factor, carbohydrate ration 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
- Age ≥ 18 years
- 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 3 months.
- 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 settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor | Device | intervantion group |
Primary outcome
Time spent in the normal range
Time frame: during each 6 days iteration
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 meaningful improvement in the primary outcome
Time frame: Day 78
time spent above 180 mg/dl
Time frame: during each 6 days iteration
time spent below 70 mg/dl
Time frame: during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
Time frame: during each 6 days iteration
Adverse event
Time frame: during each 6 days iteration
glucose variability- area under the curve
Time frame: during each 6 days iteration
Quality of Life Questionaires
Time frame: At the end of the study- day 30 -78
Number of MDLAP-recommendations that were rejected by the physician
Time frame: during each 6 days iteration
Number and type of changes in any pump setting per iteration
Time frame: during each 6 days iteration
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 and Insulin Pump Therapy, 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 7 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: during each 6 days iteration). 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.