Use of an Automated Insulin Delivery System Compared to Sensor Augmented Pump at Patients With Type 1 Diabetes (T1D)

NCT02636491 | Completed DMC

• 1 other identifier: MC-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• normal glucose level

  Percentage of Glucose sensor readings within 70 to 180mg/dl (3.9 to 10 mmol/l)

  60 hours

Secondary Outcomes (3)

• Hypoglycemia

  60 hours

• increased glucose level

  60 hours

• glucose sensor readings

  90 hours

Study Arms (2)

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

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

Device: MiniMed Paradigm® Veo™ System

Interventions

MD-Logic-Automated Insulin Delivery System DEVICE

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.

Also known as: Closed loop

investigational device

MiniMed Paradigm® Veo™ System DEVICE

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.

Also known as: sensor augmented continuous subcutaneous insulin infusion

MiniMed Paradigm® Veo™ System

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients willing to follow study instructions
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead

Study Sites (1)

Kinder - und Jugendkrankenhaus AUF DER BULT

Hanover, 30173, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thomas Danne, MD

  Kinder- und Jugendkrankenhaus AUF DER BULT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 21, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)