Patient CareNCT03815487
Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)
A study testing Medtronic MiniMed 670G Insulin Pump in Auto Mode and Medtronic MiniMed 670G Insulin Pump without Auto Mode in people with Patient Care and Drug Therapy, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial summary
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Patient Care, Drug Therapy
- What is being tested?
- Medtronic MiniMed 670G Insulin Pump in Auto Mode and Medtronic MiniMed 670G Insulin Pump without Auto Mode
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 19 Nov 2018to 10 Oct 2020
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- General Inclusion Criteria
- At time of screening: Subjects who are 2-14 years are determined by the investigator to be psychologically sound (e.g. no depression, anxiety disorder, traumatic stress disorder) in order to successfully participate in this study
- Subject has been diagnosed with type 1 diabetes ≥ 1 year Study-specific inclusion criteria
- Subjects will be considered for enrollment in the study if they meet all of the following criteria:
- Subjects who are 2-14 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
- Subject is willing to wear the system continuously throughout the study
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- Subject is willing to perform required sensor calibrations
- Total daily dose of Insulin >8 U
- Subject has an A1C value < 12.0% (as processed by Laboratory) at time of screening visit
- Subject must be on Pump therapy for >3 months prior to Screening
- Subject may also be on sensor augmented pump therapy.
- If subject has celiac disease it has been adequately treated as proven by Transglutamase-Antibodies in normal range
Who cannot join
- Event of severe hypoglycemia in past 3 months (as per ISPAD Guideline Definition 2014: seizure or loss of consciousness.)
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
- Subject has had any of the following new diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Subject has a clinical significant abnormality (out of reference range, as processed by Laboratory) in thyroid-stimulating hormone (TSH) at time of screening visit
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- Subjects suffering from Morbus Addison, heart failure >NYHA II, chronic pulmonal disease >GOLD II, chronic arterial insuffiency, known cancer disease, diabetic kidney disease, diabetic autonom or peropheral neuropathy
- Subject tests positive in the drug screen
- Subject has taken any oral, injectable, or IV steroids within 8 weeks prior time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study; furthermore patients using antipsychotic drugs, antidepressive, ß-blocking agents are not permitted to participate
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 4 weeks
- Subject is currently abusing illicit drugs
- Subject is currently abusing prescription drugs
- Subject is currently abusing alcohol
- Subject is using pramlintide (Symlin) at time of screening
- Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
- Subject has elective surgery planned that requires general anesthesia during the course of the study
- Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject diagnosed with current eating disorder such as anorexia or bulimia
- Subject has been diagnosed with chronic kidney disease that results in chronic anemia
- Subject is on dialysis
- Subjects known for factitial hypoglycemia or possible suicidal tendencies.
- Patients who are unwilling or unable to perform a minimum of four blood glucose tests per day.
- People who are unwilling or unable to maintain contact with their healthcare professional.
- Patients whose vision or hearing does not allow cognition of pump signals and alarms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Sensor-augmented Pump Therapy Versus Hybrid Closed-loop Glucose Management (MiniMed670G™) in Patients With Type 1 Diabetes at Home in a Randomized Controlled Trial
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. This Hybrid closed loop (HCL) system provides several additional effects compared to SAP therapy: according to actual and predicted sensor glucose values, the insulin therapy can be adopted automatically by pump: in case of high values (or predicted) more insulin will be administered, in case of low values (or predicted) the insulin infusion will be decreased a suspended and resumed again. So the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.
The aim of the current trial is to compare the SAP-therapy with the hybrid closed loop glucose management in patients with type 1 diabetes at home.
Read the detailed description
Monocentric, randomized, controlled cross-over safety evaluation study. For the study, 20 subjects per age group (small children 2-<9 years, children/adolescents ≥9-14 years) will be enrolled (total n=40). The study is anticipated to last no longer than 6 months from investigational center initiation to completion of all data entry and monitoring procedures. It is estimated that all subjects will be enrolled into the study within approximately 3 months of study start.
- Visit 1 - Day 0: (Subjects come to clinic): Consent, Screening (incl. blood sample) and device training, training to emergency behavior; Pump Start in low glucose suspend mode, alarm settings
- Visit 2 - Week 1: Subjects come to clinic; start Run-in Period and start Sensor Augmented Pump (SAP) therapy without any SmartGuard feature, assessment of AEs; pump will be read out, data stored; subjects will be trained to use the Auto mode, Auto mode will be activated. All subjects will participate in a 11-week study period.
- Visit 3 - Week 2: Subjects are randomized to start with SAP or Hybrid Closed Loop (HCL) therapy and stay with an assigned therapy for next 4 weeks.
- Visit 4 - Week 6: End of Period 1 and start of washout period. Subjects stay in this period with SAP therapy only. Evaluation of past 4 weeks, assessment of AEs
- Visit 5 - Week 7: Period 2 starts. Evaluation of past week, assessment of AEs. SAP group will be using 670G with HCL and HCL group will be using SAP therapy for next 4 weeks.
- Visit 6 - Week 11: End of Study, Subjects come to clinic; evaluation of past 4 weeks, assessment of AEs, HbA1c; pump will be read out, data stored. All study material will be given back.
- Conditions
- Patient Care, Drug Therapy
- Being tested
- Medtronic MiniMed 670G Insulin Pump in Auto Mode, Medtronic MiniMed 670G Insulin Pump without Auto Mode
- Keywords
- pediatrics, type 1 diabetes, insulin pump, 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.
Medtronic MiniMed 670G Insulin Pump in Auto ModeDevice
Also called Hybrid Closed Loop (HCL) System
This kind of intervention will be part of the intensified insulin therapy for type 1 diabetic patients. The system will help to keep blood glucose in a defined range by automatic assisted adaption of insulin dosing.the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.
Medtronic MiniMed 670G Insulin Pump without Auto ModeDevice
Also called Sensor Augmented Pump therapy without Auto Mode
Sensor augmented pump therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. There is no automatic adaption of insulin dosing. The patients must respond manually after alarm or according to the trend arrows.
| Study group | Role | What they receive |
|---|---|---|
| Therapy with Hybrid Closed Loop (HCL) | Experimental | The Intervention is the specific function of the Insulin Pump from Medtronic® with the name "MiniMed® 670G (MMT-1780)" to deliver Insulin as medication.
This Medtronic MiniMed 670G Insulin Pump in Auto Mode is an Hybrid closed loop (HCL) system including an Auto Mode function. It provides as intervention several additional effects concerning automatically insulin delivery by pump: e.g. in case of high values (or predicted) - more insulin will be administered automatically, in case of low values (or predicted) - the insulin infusion will be decreased a suspended and resumed again. The patients will wear the pump continuously. Receives: Device: Medtronic MiniMed 670G Insulin Pump in Auto Mode |
| Sensor Augmented Pump (SAP) therapy | Active comparator | The Intervention is the specific therapy of the Sensor Augmented Insulin Pump "MiniMed® 670G" (MMT-1780) without Auto Mode.
This Medtronic MiniMed 670G Insulin Pump without Auto Mode' is a Sensor Augmented Pump (SAP) therapy and means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. The patients will wear the pump also continuously, but have to respond manually after the alarm. There are no automatically steps from the pump. Receives: Device: Medtronic MiniMed 670G Insulin Pump without Auto Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Sensor Glucose
Time in Range (% of Sensor Glucose 70-180 mg/dL) (SAP period vs Hybrid Closed loop)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start19 Nov 2018
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient CareStudies 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
- 40 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, Diabetes Centre for Children and Adolescents, Kinderkrankenhaus AUF DER BULT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815487
- Sponsor's protocol ID
- PSH-KKB1/ NERP15-028
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2018
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Sensor-augmented Pump Therapy Versus Hybrid Closed-loop Glucose Management (MiniMed670G™) in Patients With Type 1 Diabetes at Home in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03815487
- Acronym / sponsor ID
- PSH-KKB1/ NERP15-028
- Conditions
- Patient Care, Drug Therapy
- Keywords
- pediatrics, type 1 diabetes, insulin pump, closed loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 24 Jan 2019 (actual)
- 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.
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. This Hybrid closed loop (HCL) system provides several additional effects compared to SAP therapy: according to actual and predicted sensor glucose values, the insulin therapy can be adopted automatically by pump: in case of high values (or predicted) more insulin will be administered, in case of low values (or predicted) the insulin infusion will be decreased a suspended and resumed again. So the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.
The aim of the current trial is to compare the SAP-therapy with the hybrid closed loop glucose management in patients with type 1 diabetes at home.
Detailed description
Monocentric, randomized, controlled cross-over safety evaluation study. For the study, 20 subjects per age group (small children 2-<9 years, children/adolescents ≥9-14 years) will be enrolled (total n=40). The study is anticipated to last no longer than 6 months from investigational center initiation to completion of all data entry and monitoring procedures. It is estimated that all subjects will be enrolled into the study within approximately 3 months of study start.
- Visit 1 - Day 0: (Subjects come to clinic): Consent, Screening (incl. blood sample) and device training, training to emergency behavior; Pump Start in low glucose suspend mode, alarm settings
- Visit 2 - Week 1: Subjects come to clinic; start Run-in Period and start Sensor Augmented Pump (SAP) therapy without any SmartGuard feature, assessment of AEs; pump will be read out, data stored; subjects will be trained to use the Auto mode, Auto mode will be activated. All subjects will participate in a 11-week study period.
- Visit 3 - Week 2: Subjects are randomized to start with SAP or Hybrid Closed Loop (HCL) therapy and stay with an assigned therapy for next 4 weeks.
- Visit 4 - Week 6: End of Period 1 and start of washout period. Subjects stay in this period with SAP therapy only. Evaluation of past 4 weeks, assessment of AEs
- Visit 5 - Week 7: Period 2 starts. Evaluation of past week, assessment of AEs. SAP group will be using 670G with HCL and HCL group will be using SAP therapy for next 4 weeks.
- Visit 6 - Week 11: End of Study, Subjects come to clinic; evaluation of past 4 weeks, assessment of AEs, HbA1c; pump will be read out, data stored. All study material will be given back.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy with Hybrid Closed Loop (HCL) | Experimental | Device: Medtronic MiniMed 670G Insulin Pump in Auto ModeThe Intervention is the specific function of the Insulin Pump from Medtronic® with the name "MiniMed® 670G (MMT-1780)" to deliver Insulin as medication. This Medtronic MiniMed 670G Insulin Pump in Auto Mode is an Hybrid closed loop (HCL) system including an Auto Mode function. It provides as intervention several additional effects concerning automatically insulin delivery by pump: e.g. in case of high values (or predicted) - more insulin will be administered automatically, in case of low values (or predicted) - the insulin infusion will be decreased a suspended and resumed again. The patients will wear the pump continuously. |
| Sensor Augmented Pump (SAP) therapy | Active comparator | Device: Medtronic MiniMed 670G Insulin Pump without Auto ModeThe Intervention is the specific therapy of the Sensor Augmented Insulin Pump "MiniMed® 670G" (MMT-1780) without Auto Mode. This Medtronic MiniMed 670G Insulin Pump without Auto Mode' is a Sensor Augmented Pump (SAP) therapy and means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. The patients will wear the pump also continuously, but have to respond manually after the alarm. There are no automatically steps from the pump. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- General Inclusion Criteria
- At time of screening: Subjects who are 2-14 years are determined by the investigator to be psychologically sound (e.g. no depression, anxiety disorder, traumatic stress disorder) in order to successfully participate in this study
- Subject has been diagnosed with type 1 diabetes ≥ 1 year Study-specific inclusion criteria
- Subjects will be considered for enrollment in the study if they meet all of the following criteria:
- Subjects who are 2-14 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
Key exclusion criteria (25 listed)
- Event of severe hypoglycemia in past 3 months (as per ISPAD Guideline Definition 2014: seizure or loss of consciousness.)
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
- Subject has had any of the following new diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
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 |
|---|---|---|
| Medtronic MiniMed 670G Insulin Pump in Auto ModeAlso: Hybrid Closed Loop (HCL) SystemThis kind of intervention will be part of the intensified insulin therapy for type 1 diabetic patients. The system will help to keep blood glucose in a defined range by automatic assisted adaption of insulin dosing.the HCL provides a lot more automatic functions to keep glucose in target compared to SAP. | Device | Therapy with Hybrid Closed Loop (HCL) |
| Medtronic MiniMed 670G Insulin Pump without Auto ModeAlso: Sensor Augmented Pump therapy without Auto ModeSensor augmented pump therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. There is no automatic adaption of insulin dosing. The patients must respond manually after alarm or according to the trend arrows. | Device | Sensor Augmented Pump (SAP) therapy |
Primary outcome
Reduction of Sensor Glucose
Time frame: 6 month
Time in Range (% of Sensor Glucose 70-180 mg/dL) (SAP period vs Hybrid Closed loop)
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 16 Jun 2021.
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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
Diabetes Centre for Children and Adolescents, Kinderkrankenhaus 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 Medtronic MiniMed 670G Insulin Pump in Auto Mode and Medtronic MiniMed 670G Insulin Pump without Auto Mode in people with Patient Care and Drug Therapy, 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 12 inclusion and 25 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 16 Jun 2021. 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. 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?
Reduction of Sensor Glucose (time frame: 6 month). 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 16 Jun 2021.