Type 1 DiabetesNCT01726829
Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home
A study testing MD-Logic Artificial Pancreas (MDLAP) system and sensor augmented pump therapy in people with Type 1 Diabetes, run by Rabin Medical Center at 3 sites in 3 countries.
Trial summary
This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; In this study,75… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- MD-Logic Artificial Pancreas (MDLAP) system and sensor augmented pump therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2012to Dec 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Insulin infusion pump therapy for at least 3 months
- Patients whom used continuous glucose sensor previously
- Age at inclusion ≥ 10 years and ≤ 65 years
- HbA1c at inclusion ≥ 7 and <10
- Patients willing to follow study instructions
Show all 10Show fewer
- Patients live with at least one other adult person
- BMI SDS(Standard Deviation Score) - below the 97th percentile for age
- An internet connection at patient's home
- Patients with care givers who are capable of operating a computer based system
Who cannot join
- Concomitant diseases that 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 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
- 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
- Female subject who is pregnant or planning to become pregnant within the planned study duration
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home, Pilot Study.
This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.
Read the detailed description
In the last two decades, remarkable technological progress has been made with the development of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless communications, interest in the closed-loop insulin delivery was revived.
Control trails that evaluate the clinical benefits of continuous glucose sensor have shown improved HbA1c with no significant increase in sever hypoglycemia, trend towards lower hypoglycemic episodes although not significant and no significant change in sever hypoglycemia. One of the main drawbacks of continuous glucose sensor is noncompliant of the patient, the flow of information and the need to act accordingly makes this devise a burden for some patients. Theoretically subcutaneous insulin pumps and glucose sensors attached to an artificial pancreas in a closed-loop system can mimic the activity of functioning pancreatic beta cells, with strict control of blood glucose levels. Such a system may also offer an opportunity to free the patients from the daily burden of dealing with their diabetes.
Study Objectives are to determine the safety and efficacy of using the MDLAP system to automatically control overnight blood glucose in type 1 diabetic patients. Overnight glucose control time defined as the time range between bedtime (21:00-23:00 PM) and awaking time (7:00 AM).
This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; 75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.
- Conditions
- Type 1 Diabetes
- Being tested
- MD-Logic Artificial Pancreas (MDLAP) system, sensor augmented pump therapy
- 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-Logic Artificial Pancreas (MDLAP) systemDevice
Also called four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system
sensor augmented pump therapyProcedure or surgery
Also called four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy
| Study group | Role | What they receive |
|---|---|---|
| MD-Logic Artificial Pancreas (MDLAP) system | Experimental | four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system Receives: Device: MD-Logic Artificial Pancreas (MDLAP) system |
| Standard treatment with sensor augmented pump therapy | Active comparator | four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy Receives: Procedure: sensor augmented pump therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time sensor glucose level spent below 70mg/dl
Measured: final visit (day 44)
The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl
Measured: At final visit (day 44)
Secondary outcomes (12)
The time sensor glucose level spent within 70-140 mg/dl
Measured: At final visit (day 44)
The number and frequency of hypoglycemic events below 63, 79 mg/dl
Measured: At final visit (day 44)
The time sensor glucose level spent above 140, 180 mg/dl
Measured: At final visit (day 44)
The area under the curve <63, <70, >140, >180 mg/dl
Measured: At final visit (day 44)
Glucose variability
glucose variability measured as the standard deviation from the mean glucose
Measured: At final visit (day 44)
The total insulin dose during the overnight period
Measured: At the final visit (day 44)
Artificial pancreas technical performance defined as total frequency of technical failures
Measured: at final visit (day 44)
Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records
Measured: At final vist (day 44)
Percentage of time of active closed loop control
percentage of time that the MDLAP system worked without any technical problem
Measured: At final visit (day 44)
Fear of Hypoglycemia questionnaire
Measured: At final visit (day 44)
Acceptance questionnaire
Measured: At final visit (day 44)
Artificial Pancreas Satisfaction Questionnaire
Measured: At final visit (day 44)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, MD, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726829
- Sponsor's protocol ID
- rmc007053ctil
- Status last verified
- Apr 2016
- First submitted
- 8 Nov 2012
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nimri R, Muller I, Atlas E, Miller S, Kordonouri O, Bratina N, Tsioli C, Stefanija MA, Danne T, Battelino T, Phillip M. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis. Pediatr Diabetes. 2014 Mar;15(2):91-9. doi: 10.1111/pedi.12071. Epub 2013 Aug 15.
PubMed 23944875
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home, Pilot Study.
- ClinicalTrials.gov ID
- NCT01726829
- Acronym / sponsor ID
- rmc007053ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Artificial Pancreas, Closed Loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Nov 2012 (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.
This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.
Detailed description
In the last two decades, remarkable technological progress has been made with the development of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless communications, interest in the closed-loop insulin delivery was revived.
Control trails that evaluate the clinical benefits of continuous glucose sensor have shown improved HbA1c with no significant increase in sever hypoglycemia, trend towards lower hypoglycemic episodes although not significant and no significant change in sever hypoglycemia. One of the main drawbacks of continuous glucose sensor is noncompliant of the patient, the flow of information and the need to act accordingly makes this devise a burden for some patients. Theoretically subcutaneous insulin pumps and glucose sensors attached to an artificial pancreas in a closed-loop system can mimic the activity of functioning pancreatic beta cells, with strict control of blood glucose levels. Such a system may also offer an opportunity to free the patients from the daily burden of dealing with their diabetes.
Study Objectives are to determine the safety and efficacy of using the MDLAP system to automatically control overnight blood glucose in type 1 diabetic patients. Overnight glucose control time defined as the time range between bedtime (21:00-23:00 PM) and awaking time (7:00 AM).
This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; 75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD-Logic Artificial Pancreas (MDLAP) system | Experimental | Device: MD-Logic Artificial Pancreas (MDLAP) systemfour consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system |
| Standard treatment with sensor augmented pump therapy | Active comparator | Procedure: sensor augmented pump therapyfour consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Insulin infusion pump therapy for at least 3 months
- Patients whom used continuous glucose sensor previously
- Age at inclusion ≥ 10 years and ≤ 65 years
- HbA1c at inclusion ≥ 7 and <10
Key exclusion criteria (8 listed)
- Concomitant diseases that 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 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
- Diabetic ketoacidosis in the past 1 month
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 Artificial Pancreas (MDLAP) systemAlso: four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system | Device | MD-Logic Artificial Pancreas (MDLAP) system |
| sensor augmented pump therapyAlso: four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy | Procedure or surgery | Standard treatment with sensor augmented pump therapy |
Primary outcome
time sensor glucose level spent below 70mg/dl
Time frame: final visit (day 44)
The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl
Time frame: At final visit (day 44)
12 secondary outcomes
The time sensor glucose level spent within 70-140 mg/dl
Time frame: At final visit (day 44)
The number and frequency of hypoglycemic events below 63, 79 mg/dl
Time frame: At final visit (day 44)
The time sensor glucose level spent above 140, 180 mg/dl
Time frame: At final visit (day 44)
The area under the curve <63, <70, >140, >180 mg/dl
Time frame: At final visit (day 44)
Glucose variability
Time frame: At final visit (day 44)
The total insulin dose during the overnight period
Time frame: At the final visit (day 44)
Artificial pancreas technical performance defined as total frequency of technical failures
Time frame: at final visit (day 44)
Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records
Time frame: At final vist (day 44)
Percentage of time of active closed loop control
Time frame: At final visit (day 44)
Fear of Hypoglycemia questionnaire
Time frame: At final visit (day 44)
Acceptance questionnaire
Time frame: At final visit (day 44)
Artificial Pancreas Satisfaction Questionnaire
Time frame: At final visit (day 44)
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 8 Apr 2016.
- Derived from this study: PubMed 23944875Nimri R, Muller I, Atlas E, Miller S, Kordonouri O, Bratina N, Tsioli C, Stefanija MA, Danne T, Battelino T, Phillip M. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis. Pediatr Diabetes. 2014 Mar;15(2):91-9. doi: 10.1111/pedi.12071. Epub 2013 Aug 15.
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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, MD principal investigator
Schneider Children's Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD-Logic Artificial Pancreas (MDLAP) system and sensor augmented pump therapy in people with Type 1 Diabetes, run by Rabin Medical Center at 3 sites in 3 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 10 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, 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 sensor glucose level spent below 70mg/dl (time frame: final visit (day 44)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726829, which also lists 1 linked publication.
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 8 Apr 2016.