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Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)

Primary Purpose

Patient Care, Drug Therapy

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Medtronic MiniMed 670G Insulin Pump in Auto Mode

Medtronic MiniMed 670G Insulin Pump without Auto Mode

About this trial

This is an interventional treatment trial for Patient Care focused on measuring pediatrics, type 1 diabetes, insulin pump, closed loop

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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.

Sites / Locations

Kinder - und Jugendkrankenhaus AUF DER BULT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapy with Hybrid Closed Loop (HCL)

Sensor Augmented Pump (SAP) therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction of Sensor Glucose

Time in Range (% of Sensor Glucose 70-180 mg/dL) (SAP period vs Hybrid Closed loop)

Secondary Outcome Measures

Full Information

NCT ID

NCT03815487

First Posted

December 5, 2018

Last Updated

June 15, 2021

Sponsor

Kinderkrankenhaus auf der Bult

1. Study Identification

Unique Protocol Identification Number

NCT03815487

Brief Title

Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

November 19, 2018 (Actual)

Primary Completion Date

October 10, 2020 (Actual)

Study Completion Date

October 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kinderkrankenhaus auf der Bult

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patient Care, Drug Therapy

Keywords

pediatrics, type 1 diabetes, insulin pump, closed loop

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Therapy with Hybrid Closed Loop (HCL)

Arm Type

Experimental

Arm Description

Arm Title

Sensor Augmented Pump (SAP) therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Medtronic MiniMed 670G Insulin Pump in Auto Mode

Other Intervention Name(s)

Hybrid Closed Loop (HCL) System

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Medtronic MiniMed 670G Insulin Pump without Auto Mode

Other Intervention Name(s)

Sensor Augmented Pump therapy without Auto Mode

Intervention Description

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.

Primary Outcome Measure Information:

Title

Reduction of Sensor Glucose

Description

Time in Range (% of Sensor Glucose 70-180 mg/dL) (SAP period vs Hybrid Closed loop)

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Danne, MD

Organizational Affiliation

Diabetes Centre for Children and Adolescents, Kinderkrankenhaus AUF DER BULT

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kinder - und Jugendkrankenhaus AUF DER BULT

City

Hannover

ZIP/Postal Code

30173

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)

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