Type 1 DiabetesNCT02733211
Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes
A study testing MD- Logic Closed Loop System and sensor augmented pump therapy in people with Type 1 Diabetes, run by Rabin Medical Center at 2 sites in 2 countries.
Trial summary
The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial glucose to aid in the management of their 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 Closed Loop System and sensor augmented pump therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2019to Dec 2019
- 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 >1year since diagnosis
- Insulin infusion pump (CSII) therapy for at least 3 months
- Patients able to use sensor after training based on researcher's estimation
- Age between 10 and 18 years (both included)
- HbA1c at inclusion between 7.5 and 11.0 % (both included)
- Patients willing to follow study instructions
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- Patients live with at least one other adult person
- Body Mass Index Standard Deviation Score - below the 95th percentile for age
- Patients with caregivers who are capable of operating a computer based system
Who cannot join
- Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical condition, which in the Investigator's opinion, may compromise patient safety Participation in any other interventional study
- Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices and planned imaging
- 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
- Diabetic ketoacidosis in the past 1 month
- Severe hypoglycemia six month prior to enrollment
- Current use of the following medications: medications that are used to lower blood glucose , Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study
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- Subject is participating in another drug or device study that could affect glucose measurements or glucose management
- Female subject who is pregnant or breast-feeding or is planning to become pregnant within the planned study duration
- Not sufficient vision or hearing to recognize pump/sensor alarms or to perform Blood Glucose-self measurements 4-times daily.
- Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus -Subject has unstable or rapidly progressive renal disease or is receiving dialysis-
- Subject has active proliferating retinopathy
- Active gastroparesis
- Patient suffers from an eating disorder
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes at Home
The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial glucose to aid in the management of their diabetes. The product automatically adjusts basal insulin delivery and delivers correction boluses in response to real-time glucose measurements by CGM to maintain blood glucose within the desired range, to improve metabolic control without increasing the risk of hypoglycemia.
The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the safety and efficacy of night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy in poorly controlled patients with type 1 diabetes at home The objective of this pilot study is to evaluate the safety and efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly controlled type 1 diabetes at patient's home
- Conditions
- Type 1 Diabetes
- Being tested
- MD- Logic Closed Loop System, sensor augmented pump therapy
- Keywords
- 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- Logic Closed Loop SystemDevice
Closed Loop System
sensor augmented pump therapyDevice
Sensor augmented pump therapy
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop System | Experimental | MD-Logic automated insulin delivery system - all subjects wearing the study system during nights over 4 weeks Receives: Device: MD- Logic Closed Loop System |
| Sensor augmented pump therapy | Active comparator | Sensor augmented pump therapy - all subjects are using sensor augmented pump therapy over 4 weeks Receives: Device: sensor augmented pump therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) during the night (23:00-7:00 h)
Measured: At the final visit- Day 115
Secondary outcomes (21)
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) per 24 hours
Measured: At the final visit- Day 115
Percentage of glucose sensor readings below 70 mg/dl (3.9 mmol/l) during the night (23:00-7:00 h) and per 24 hours
Measured: At the final visit- Day 115
Percentage of glucose sensor readings above 180 mg/dl (10 mmol/l) during the night (23:00-7:00 h) and per 24 hours
Measured: At the final visit- Day 115
Average and standard deviation of glucose sensor readings per 24 hours
Measured: At the final visit- Day 115
Fasting blood glucose levels
Measured: At the final visit- Day 115
HbA1c change from baseline to the end of the intervention period
Measured: At the final visit- Day 115
Acceptance and use intention of an Artificial Pancreas
Questionnaire assessing the acceptance and use intention of an Artificial Pancreas
Measured: At the final visit- Day 115
Well-Being
Questionnaire assessing the well-being of participants
Measured: At the final visit- Day 115
Diabetes-specific family conflicts
Questionnaire assessing the diabetes-specific family conflicts of participants
Measured: At the final visit- Day 115
Area under the curve of glucose readings <50
Measured: At the final visit- Day 115
Area under the curve of glucose readings <70
Measured: At the final visit- Day 115
Area under the curve of glucose readings <60
Measured: At the final visit- Day 115
Percentage of glucose readings <70 mg/dl
Measured: At the final visit- Day 115
Percentage of glucose readings <60 mg/dl
Measured: At the final visit- Day 115
Number of sensor based hypoglycemic events <70mg/dl
Measured: At the final visit- Day 115
Number of sensor based hypoglycemic events <60mg/d
Measured: At the final visit- Day 115
Number of sensor based hypoglycemic events <50mg/d
Measured: At the final visit- Day 115
Area Under the Curve of sensor glucose readings >240 mg/dl
Measured: At the final visit- Day 115
Area Under the Curve of sensor glucose readings >300 mg/dl
Measured: At the final visit- Day 115
Percentage of sensor glucose readings >240 mg/dl
Measured: At the final visit- Day 115
Percentage of sensor glucose readings >300 mg/dl
Measured: At the final visit- Day 115
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startMar 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Finally it was decided not to initiate the study due to logistical issues
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GIF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733211
- Sponsor's protocol ID
- RMC010016Ctil
- Status last verified
- Dec 2019
- First submitted
- 5 Apr 2016
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes at Home
- ClinicalTrials.gov ID
- NCT02733211
- Acronym / sponsor ID
- RMC010016Ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Closed Loop
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Finally it was decided not to initiate the study due to logistical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- GIF
- Study start
- Mar 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Apr 2016 (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 MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial glucose to aid in the management of their diabetes. The product automatically adjusts basal insulin delivery and delivers correction boluses in response to real-time glucose measurements by CGM to maintain blood glucose within the desired range, to improve metabolic control without increasing the risk of hypoglycemia.
The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the safety and efficacy of night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy in poorly controlled patients with type 1 diabetes at home The objective of this pilot study is to evaluate the safety and efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly controlled type 1 diabetes at patient's home
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Loop System | Experimental | Device: MD- Logic Closed Loop SystemMD-Logic automated insulin delivery system - all subjects wearing the study system during nights over 4 weeks |
| Sensor augmented pump therapy | Active comparator | Device: sensor augmented pump therapySensor augmented pump therapy - all subjects are using sensor augmented pump therapy over 4 weeks |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Subject with type 1 diabetes >1year since diagnosis
- Insulin infusion pump (CSII) therapy for at least 3 months
- Patients able to use sensor after training based on researcher's estimation
- Age between 10 and 18 years (both included)
- HbA1c at inclusion between 7.5 and 11.0 % (both included)
Key exclusion criteria (13 listed)
- Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical condition, which in the Investigator's opinion, may compromise patient safety Participation in any other interventional study
- Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices and planned imaging
- 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
- Diabetic ketoacidosis in the past 1 month
- Severe hypoglycemia six 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 Closed Loop SystemClosed Loop System | Device | Closed Loop System |
| sensor augmented pump therapySensor augmented pump therapy | Device | Sensor augmented pump therapy |
Primary outcome
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) during the night (23:00-7:00 h)
Time frame: At the final visit- Day 115
21 secondary outcomes
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) per 24 hours
Time frame: At the final visit- Day 115
Percentage of glucose sensor readings below 70 mg/dl (3.9 mmol/l) during the night (23:00-7:00 h) and per 24 hours
Time frame: At the final visit- Day 115
Percentage of glucose sensor readings above 180 mg/dl (10 mmol/l) during the night (23:00-7:00 h) and per 24 hours
Time frame: At the final visit- Day 115
Average and standard deviation of glucose sensor readings per 24 hours
Time frame: At the final visit- Day 115
Fasting blood glucose levels
Time frame: At the final visit- Day 115
HbA1c change from baseline to the end of the intervention period
Time frame: At the final visit- Day 115
Acceptance and use intention of an Artificial Pancreas
Time frame: At the final visit- Day 115
Well-Being
Time frame: At the final visit- Day 115
Diabetes-specific family conflicts
Time frame: At the final visit- Day 115
Area under the curve of glucose readings <50
Time frame: At the final visit- Day 115
Area under the curve of glucose readings <70
Time frame: At the final visit- Day 115
Area under the curve of glucose readings <60
Time frame: At the final visit- Day 115
Percentage of glucose readings <70 mg/dl
Time frame: At the final visit- Day 115
Percentage of glucose readings <60 mg/dl
Time frame: At the final visit- Day 115
Number of sensor based hypoglycemic events <70mg/dl
Time frame: At the final visit- Day 115
Number of sensor based hypoglycemic events <60mg/d
Time frame: At the final visit- Day 115
Number of sensor based hypoglycemic events <50mg/d
Time frame: At the final visit- Day 115
Area Under the Curve of sensor glucose readings >240 mg/dl
Time frame: At the final visit- Day 115
Area Under the Curve of sensor glucose readings >300 mg/dl
Time frame: At the final visit- Day 115
Percentage of sensor glucose readings >240 mg/dl
Time frame: At the final visit- Day 115
Percentage of sensor glucose readings >300 mg/dl
Time frame: At the final visit- Day 115
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: No
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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.
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 Closed Loop System and sensor augmented pump therapy 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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 30 Dec 2019. 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 Germany, 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) during the night (23:00-7:00 h) (time frame: At the final visit- Day 115). 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 30 Dec 2019.