Type 1 DiabetesDREAM5NCT02636491
Use of an Automated Insulin Delivery System Compared to Sensor Augmented Pump at Patients With Type 1 Diabetes (T1D)
A study testing MD-Logic-Automated Insulin Delivery System and MiniMed Paradigm® Veo™ System in people with Type 1 Diabetes, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial summary
Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy at patients with type 1 diabetes at home Indication: Type 1 Diabetes mellitus using an… 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-Automated Insulin Delivery System and MiniMed Paradigm® Veo™ System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Jun 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 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 (CSII) therapy for at least 3 months
- Patients using a Continuous glucose monitoring system
- Age ≥ 10 years until 65 years
- HbA1c at inclusion ≥ 7 and <10
- Patients willing to follow study instructions
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- Patients live with at least one other adult person
- BMI SDS (Standard Deviation Scores) - below the 95th percentile for age32
- Patients with care givers 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 as the following examples:
- Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine > 1.5 mg/dL)
- Subject has had any of the following diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery disease or congestive heart failure, coronary artery surgery, transient ischemic attack, cerebrovascular accident, uncontrolled hypertension, ventricular rhythm disturbances or thromboembolic disease Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- 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 (such as pacemaker, ICD) and planned imaging examinations (such as MRI).
- 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
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- 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 such as Pramilintide, Metformin and GLP-1 (Glucagon-like Peptide-1) analogs. Beta blockers, glucocorticoids and 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 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
1 site in 1 country.
About this study
Official title: Open-label, 3 Center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of 60 Hours Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy at T1D Patients at Home
Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy at patients with type 1 diabetes at home Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at patient's home.
The duration of study participation for one subject is 28-56 days and the overall duration of the study is 6 months The participants of the study are patients ≥ 10 years until 65 years with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose sensors.
Sample Size n = 45
Read the detailed description
Up to 45 eligible patients will be enrolled to participate in two crossover sessions of 60 hours of consecutive days, with closed-loop or sensor-augmented pump therapy (Minimed ®Paradigm). The sequence of the sessions will be randomly assigned. The randomization will be blocked randomization (1:1). Patients will be assigned to one of the following arm: Group A: 60 hours under closed-loop control and then 60 hours of sensor augmented pump therapy and Group B: 60 hours using sensor augmented pump therapy and then 60 hours under closed-loop control.
Subjects will be enrolled according to the following schedule/ successive phases:
Phase 1: 5 Adult subjects: After all adult subjects have completed the study the 2nd enrollment phase starts.
Phase 2: 5 Adolescent subjects aged 14-18. After these subjects have completed the study the 3rd enrollment phase starts.
Phase 3: 5 Children aged 10-14 will be enrolled.
The enrollment of phase 2 and phase 3 will not be started before all participants of the previous phase completed the study and the safety and efficacy of the system has been analyzed based on the occurrence of (serious) adverse Events (AE) or any other issue relevant for patient's safety. If the observed AEs or device problems do not exceed the amount or severity of the risks expected during a regular diabetes therapy and the recruitment of the next age category is considered reasonable from the medical point of view, the next enrollment phase will be started.Screening Failures will be replaced to get a total of 45 completed patients.The average duration of study participation for subjects completing the study is estimated to be approximately 28-56 days. The estimated duration of the total study is 6 months.In this study 45 patients will be included, 15 are planned to be enrolled in Germany.
The study will consist of 5 visits (3 clinical visits and 2 visits will be done by phone) as followed:
- Visit 1: Screening, eligibility, enrolment and sensor and diabetes guidelines training. (Day - 21)
- Run-in period
- Visit 2: Randomization and preparation visit for the outpatient period. (Day 0)
- Intervention session 1 (same weekdays as Intervention session 2)
- Visit 3: Phone call visit between arms. (Day 4)
- Washout period
- Visit 4: Phone call visit before session 2 (Day 18)
- Intervention session 2 (same weekdays as Intervention session 1)
- Visit 5: Final visit. (Day 21)
There is no follow up visit or observation planned after the end of the study or after a subject discontinued study participation. In case of a Serious Adverse Event (SAE) a follow up period until this SAE is resolved/ recovered is planned.
- Conditions
- Type 1 Diabetes
- Being tested
- MD-Logic-Automated Insulin Delivery System, MiniMed Paradigm® Veo™ System
- 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-Automated Insulin Delivery SystemDevice
Also called Closed loop
Subjects will undergo 60 hours at home under MD-Logic control and continuing with their regular routine life. At evening of the first intervention day patients will switch to MD-Logic control. Patients will be asked to connect study sensor and pump to the computer using the MD-Logic software. After the activation of the MD-Logic system, basal insulin dosing and correction boluses will be fully automated and controlled by the MD-Logic system except to meal boluses. Patients will be encouraged to measure capillary blood glucose at least 4 times a day, before each meal and before bed time. After the third night the patient will turn the closed-loop controller "OFF", this will automatically save the log file. The patient will return to his regular insulin treatment.
MiniMed Paradigm® Veo™ SystemDevice
Also called sensor augmented continuous subcutaneous insulin infusion
Subjects use 60 hours at home their conventional insulin pump and continuing with their regular Routine life. During this therapy the Insulin pump operating separately and are not controlled by the MD-Logic System.
| Study group | Role | What they receive |
|---|---|---|
| investigational device | Experimental | MD-Logic-Automated Insulin Delivery System, Version 01.05.02
The device is being used continuously over 60 hours for insulin therapy Receives: Device: MD-Logic-Automated Insulin Delivery System |
| MiniMed Paradigm® Veo™ System | Placebo comparator | sensor augmented insulin pump
The device is being used continuously over 60 hours for insulin therapy Receives: Device: MiniMed Paradigm® Veo™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal glucose level
Percentage of Glucose sensor readings within 70 to 180mg/dl (3.9 to 10 mmol/l)
Measured: 60 hours
Secondary outcomes (3)
Hypoglycemia
Percentage of glucose sensor readings below 70 mg/dl (3.9 mmol/l)
Measured: 60 hours
increased glucose level
Percentage of glucose sensor readings above 180mg/dl (10 mmol/l)
Measured: 60 hours
glucose sensor readings
Average and Standard deviation of glucose sensor readings
Measured: 90 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Danne, MD, Principal investigator, Kinder- und Jugendkrankenhaus AUF DER BULT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636491
- Sponsor's protocol ID
- MC-01
- Acronym
- DREAM5
- Status last verified
- Feb 2018
- First submitted
- 17 Dec 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, 3 Center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of 60 Hours Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy at T1D Patients at Home
- ClinicalTrials.gov ID
- NCT02636491
- Acronym / sponsor ID
- DREAM5 / MC-01
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Dec 2015 (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.
Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy at patients with type 1 diabetes at home Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at patient's home.
The duration of study participation for one subject is 28-56 days and the overall duration of the study is 6 months The participants of the study are patients ≥ 10 years until 65 years with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose sensors.
Sample Size n = 45
Detailed description
Up to 45 eligible patients will be enrolled to participate in two crossover sessions of 60 hours of consecutive days, with closed-loop or sensor-augmented pump therapy (Minimed ®Paradigm). The sequence of the sessions will be randomly assigned. The randomization will be blocked randomization (1:1). Patients will be assigned to one of the following arm: Group A: 60 hours under closed-loop control and then 60 hours of sensor augmented pump therapy and Group B: 60 hours using sensor augmented pump therapy and then 60 hours under closed-loop control.
Subjects will be enrolled according to the following schedule/ successive phases:
Phase 1: 5 Adult subjects: After all adult subjects have completed the study the 2nd enrollment phase starts.
Phase 2: 5 Adolescent subjects aged 14-18. After these subjects have completed the study the 3rd enrollment phase starts.
Phase 3: 5 Children aged 10-14 will be enrolled.
The enrollment of phase 2 and phase 3 will not be started before all participants of the previous phase completed the study and the safety and efficacy of the system has been analyzed based on the occurrence of (serious) adverse Events (AE) or any other issue relevant for patient's safety. If the observed AEs or device problems do not exceed the amount or severity of the risks expected during a regular diabetes therapy and the recruitment of the next age category is considered reasonable from the medical point of view, the next enrollment phase will be started.Screening Failures will be replaced to get a total of 45 completed patients.The average duration of study participation for subjects completing the study is estimated to be approximately 28-56 days. The estimated duration of the total study is 6 months.In this study 45 patients will be included, 15 are planned to be enrolled in Germany.
The study will consist of 5 visits (3 clinical visits and 2 visits will be done by phone) as followed:
- Visit 1: Screening, eligibility, enrolment and sensor and diabetes guidelines training. (Day - 21)
- Run-in period
- Visit 2: Randomization and preparation visit for the outpatient period. (Day 0)
- Intervention session 1 (same weekdays as Intervention session 2)
- Visit 3: Phone call visit between arms. (Day 4)
- Washout period
- Visit 4: Phone call visit before session 2 (Day 18)
- Intervention session 2 (same weekdays as Intervention session 1)
- Visit 5: Final visit. (Day 21)
There is no follow up visit or observation planned after the end of the study or after a subject discontinued study participation. In case of a Serious Adverse Event (SAE) a follow up period until this SAE is resolved/ recovered is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| investigational device | Experimental | Device: MD-Logic-Automated Insulin Delivery SystemMD-Logic-Automated Insulin Delivery System, Version 01.05.02 The device is being used continuously over 60 hours for insulin therapy |
| MiniMed Paradigm® Veo™ System | Placebo comparator | Device: MiniMed Paradigm® Veo™ Systemsensor augmented insulin pump The device is being used continuously over 60 hours for insulin therapy |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Insulin infusion pump (CSII) therapy for at least 3 months
- Patients using a Continuous glucose monitoring system
- Age ≥ 10 years until 65 years
- HbA1c at inclusion ≥ 7 and <10
Key exclusion criteria (17 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 as the following examples:
- 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 (such as pacemaker, ICD) and planned imaging examinations (such as MRI).
- 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.
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-Automated Insulin Delivery SystemAlso: Closed loopSubjects will undergo 60 hours at home under MD-Logic control and continuing with their regular routine life. At evening of the first intervention day patients will switch to MD-Logic control. Patients will be asked to connect study sensor and pump to the computer using the MD-Logic software. After the activation of the MD-Logic system, basal insulin dosing and correction boluses will be fully automated and controlled by the MD-Logic system except to meal boluses. Patients will be encouraged to measure capillary blood glucose at least 4 times a day, before each meal and before bed time. After the third night the patient will turn the closed-loop controller "OFF", this will automatically save the log file. The patient will return to his regular insulin treatment. | Device | investigational device |
| MiniMed Paradigm® Veo™ SystemAlso: sensor augmented continuous subcutaneous insulin infusionSubjects use 60 hours at home their conventional insulin pump and continuing with their regular Routine life. During this therapy the Insulin pump operating separately and are not controlled by the MD-Logic System. | Device | MiniMed Paradigm® Veo™ System |
Primary outcome
normal glucose level
Time frame: 60 hours
Percentage of Glucose sensor readings within 70 to 180mg/dl (3.9 to 10 mmol/l)
3 secondary outcomes
Hypoglycemia
Time frame: 60 hours
increased glucose level
Time frame: 60 hours
glucose sensor readings
Time frame: 90 hours
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 28 Feb 2018.
- 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.
Thomas Danne, MD principal investigator
Kinder- und Jugendkrankenhaus AUF DER BULT
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-Logic-Automated Insulin Delivery System and MiniMed Paradigm® Veo™ System in people with Type 1 Diabetes, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
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 17 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 28 Feb 2018. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
normal glucose level (time frame: 60 hours). 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 28 Feb 2018.