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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

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ClinicalTrials.gov Identifier: NCT02733211
Recruitment Status : Not yet recruiting
First Posted : April 11, 2016
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
GIF
Information provided by (Responsible Party):
Rabin Medical Center

Brief 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. 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


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: MD- Logic Closed Loop System Device: sensor augmented pump therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Closed Loop System
MD-Logic automated insulin delivery system - all subjects wearing the study system during nights over 4 weeks
Device: MD- Logic Closed Loop System
Closed Loop System

Active Comparator: Sensor augmented pump therapy
Sensor augmented pump therapy - all subjects are using sensor augmented pump therapy over 4 weeks
Device: sensor augmented pump therapy
Sensor augmented pump therapy




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Average and standard deviation of glucose sensor readings per 24 hours [ Time Frame: At the final visit- Day 115 ]
  5. Fasting blood glucose levels [ Time Frame: At the final visit- Day 115 ]
  6. HbA1c change from baseline to the end of the intervention period [ Time Frame: At the final visit- Day 115 ]
  7. Acceptance and use intention of an Artificial Pancreas [ Time Frame: At the final visit- Day 115 ]
    Questionnaire assessing the acceptance and use intention of an Artificial Pancreas

  8. Well-Being [ Time Frame: At the final visit- Day 115 ]
    Questionnaire assessing the well-being of participants

  9. Diabetes-specific family conflicts [ Time Frame: At the final visit- Day 115 ]
    Questionnaire assessing the diabetes-specific family conflicts of participants

  10. Area under the curve of glucose readings <50 [ Time Frame: At the final visit- Day 115 ]
  11. Area under the curve of glucose readings <70 [ Time Frame: At the final visit- Day 115 ]
  12. Area under the curve of glucose readings <60 [ Time Frame: At the final visit- Day 115 ]
  13. Percentage of glucose readings <70 mg/dl [ Time Frame: At the final visit- Day 115 ]
  14. Percentage of glucose readings <60 mg/dl [ Time Frame: At the final visit- Day 115 ]
  15. Number of sensor based hypoglycemic events <70mg/dl [ Time Frame: At the final visit- Day 115 ]
  16. Number of sensor based hypoglycemic events <60mg/d [ Time Frame: At the final visit- Day 115 ]
  17. Number of sensor based hypoglycemic events <50mg/d [ Time Frame: At the final visit- Day 115 ]
  18. Area Under the Curve of sensor glucose readings >240 mg/dl [ Time Frame: At the final visit- Day 115 ]
  19. Area Under the Curve of sensor glucose readings >300 mg/dl [ Time Frame: At the final visit- Day 115 ]
  20. Percentage of sensor glucose readings >240 mg/dl [ Time Frame: At the final visit- Day 115 ]
  21. Percentage of sensor glucose readings >300 mg/dl [ Time Frame: At the final visit- Day 115 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733211


Contacts
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Contact: Moshe Phillip, Prof 972-3-9253747 mosheph@clalit.org.il

Locations
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Germany
Diabetes -Zentrum fuer kinder und jugendliche Not yet recruiting
Hannover, Germany, 30173
Contact: Olga Kordonouri, Prof    +49 511 8115 3330      
Principal Investigator: Olga Kordonouri, Prof         
Israel
Schneider Children's Medical Center Recruiting
Petach-Tikva, Israel, 49202
Contact: Moshe Phillip, Prof    972-3-9253747    mosheph@clalit.org.il   
Contact: Alona Hamou, Msc    972-3-9253778    alonah@clalit.org.il   
Principal Investigator: Moshe Phillip, Prof         
Sub-Investigator: Liora Lazar, Prof         
Sub-Investigator: Liat De Vreis, Dr.         
Sub-Investigator: Shlomit Shalitin, Prof         
Sub-Investigator: Ariel Tenenbaum, Dr.         
Sub-Investigator: Ravital Nimri, Dr.         
Sub-Investigator: Tal Oron, Dr         
Sub-Investigator: Rachel Bello, Dr         
Sub-Investigator: Demol Sharon, Dr         
Sub-Investigator: Naama Fish, Dr         
Sub-Investigator: Marie Mouler, Dr         
Sponsors and Collaborators
Rabin Medical Center
GIF

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02733211     History of Changes
Other Study ID Numbers: RMC010016Ctil
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rabin Medical Center:
Closed Loop

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs