Overnight MD-Logic

NCT01238406 | Completed

• 1 other identifier: rmc006000ctil
• Study Type: interventional
• Target: 151
• Locations: 3 countries
• Sites: 3

Brief Summary

Study design: Multicenter,randomized, prospective, open label, cross over, six segments, pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes. on the first segment 15 eligible subjects will be enrolled from the three participating centers (5 patients at each center). All 15 patients will participate in the overnight closed loop session in the hospital settings. On the second segment, 54 eligible subjects will be enrolled (18 at each center). Each subject will participate in the two consecutive overnight sessions in diabetes camp settings, one under closed-loop with MDLAP and one under sensor augmented pump therapy. In the third segment,9-20 eligible patients will be enrolled at the Israeli center only.Each subject will participate in up to four consecutive overnight under closed loop with MDLAP and up to four additional overnight under regular sensor augmented pump therapy at home. On the fourth segment, 45-60 patients will be enrolled at the Israeli center only. This segment will be conducted at a diabetes camp and will consist of two main parts. In part 1, 15-20 patients will be randomized to participate in one of the two groups: 2-4 nights under closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under closed loop control without activating the MD-Logic learning algorithm. In part 2 of the forth segment 30-40 patients will participate in two consecutive24-48 hours sessions,one under closed loop control and the second under sensor augmented pump therapy. On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only.The first 10 patients will participate in a pilot session and data gathered at this pilot session will not be used at the final analysis.This segment will consist of two parts. At part 1 each subject will participate in 4weeks-1.5 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 4 weeks-1.5 months of the study, statistical analysis will be performed in order to decide whether to extend the study with an optional period of extra 4 weeks-1.5 months.In case it will be decided to extend the study, additional 4 weeks-1.5 months intervention period following completion of final visit activities will be offered to participants. Subjects that have participated in the control group (sensor augmented pump therapy) will be offered the opportunity to continue to 4 weeks-1.5 months of closed-loop control and the study group will be offered to switch to sensor augmented pump therapy. In segment 5 part 2, up to 40 patients will be enrolled. Each patient will participate in 3 months study period either using overnight closed loop under MDLAP or sensor augmented pump therapy.Participants in segment 5 part 2 will be offered to participate in part 2A. At this part, sleep quality assessment will be made (by using actigraf and sleep questionnaire) At the end of this period an optional 3 months extension period will be offered with the other arm (cross-over) Segment 6 will be consist of two main parts.In part 1, up to 40 eligible patients will be enrolled at the Israeli center only. Each subject will participate in up to 72 hours of closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy . The sequence of the treatment intervention will be randomly assigned. The sequence of the treatment intervention will be randomly assigned. In part 2 of this segment 40 eligible patients will enrolled at the Israeli center only. Each subject will participate in up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump therapy. The sequence of the treatment intervention will be randomly assigned Objectives: The objective of this feasibility study is to evaluate the safety and efficacy of blood glucose control using the MD-Logic Artificial Pancreas System in individuals with type 1 diabetes in the hospital settings,at a diabetes camp and finally at patient's home.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Closed loop; Artificial Pancreas

Outcome Measures

Primary Outcomes (6)

• Number of hypoglycemic events

  Number of overnight hypoglycemic events below 63 mg/dl, between bed time to 07:00

  final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)

• Time spent in hypoglycemia

  Reduction of time spent in hypoglycemia defined as sensor glucose level below 60 mg/dL at segments 1\&2 below 63 mg/dl at segment 3 and below 70 mg/dl in segment 5

  final visit (day 26 for participants at segment 1 , day 14 for participants in segment 2 and day 20 for participants in segment 3, 4 weeks-1.5 months for participants in segment 5)

• Reduction in overnight mean glucose level

  Reduction in overnight mean glucose level

  final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2)

• Increase in time spent in the target range

  Increase in time spent in the target range defined as sensor glucose level within 63 to 140 mg/dl (3.5 to 7.8 mmol/l)

  day 14 for participants in segment 4

• Increase in time spent in the target range of sensor glucose level within 70-180 mg/dl

  Increase in time spent in the target range of sensor glucose level within 70-180 mg/dl

  day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6

• Sleep efficacy

  Sleep efficacy as measured by Actigraph

  final visit (after7 months for participants at segment 5 part 2A)

Secondary Outcomes (34)

• Percentage of time spent in the target range

  final visit (day 26 for participants at segment 1 , day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)

• Percentage of time spent in the tight target range

  final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)

• Average (SD) of blood glucose levels

  final visit (day 26 for participants at segment 1and 4 and day 14 for participants in segment 2, day 20 for participants in segment 3, day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6)

• Percentage of time spent below 60 mg/dl and below 70 mg/dl

  final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)

• Percentage of time spent above 140, 180, 250 mg/dl (7.8, 10, 13.9 mmol/l)

  final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3 )

Study Arms (2)

MD-logic Artificial Pancreas (MDLAP) system

EXPERIMENTAL

Use of the closed loop MD-logic Artificial Pancreas(MDLAP)System

Device: MD-logic Artificial Pancreas (MDLAP)

Standard treatment with insulin pump

ACTIVE COMPARATOR

Standard treatment with sensor augmented pump therapy

Device: Standard treatment with insulin pump

Interventions

MD-logic Artificial Pancreas (MDLAP) DEVICE

Treatment with the closed loop MD-logic Artificial Pancreas(MDLAP)System

MD-logic Artificial Pancreas (MDLAP) system

Standard treatment with insulin pump DEVICE

Standard treatment with sensor augmented pump therapy

Standard treatment with insulin pump

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 therapy for at least 3 months
• Patients whom uses continuous glucose sensor for at least 2 weeks(for segment 5) or will undergo run-in period of 2 weeks of glucose sensor wear before continue to baseline assessment (only for patients participating at segment 3 and 4)
• Age ≥ 10 years until 65 years
• Patients willing to follow trail instructions
• Patients live with at least one other adult person (segment 3, 5, and 6 only)
• BMI Standard Deviation Score - below the 97th percentile for age(in segment 5 and 6 BMI SDS - below the 95th percentile for age)
• An internet connection at patient's home (only for patients participating at segment 3 and 6)
• Patients with care givers who are capable of operating a computer based system

You may not qualify if:

• Concomitant diseases that influence metabolic control
• Participation in any other interventional study
• Known or suspected allergy to trial products
• 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 resulting in seizure or loss of consciousness in the month prior to enrollment.
• Current use of oral glucocorticoids or 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (3)

Diabetes -Zentrum fuer kinder und jugendliche

Hanover, 30173, Germany

Location

Schneider Children's Medical center

Petah Tikva, 49202, Israel

Location

University Children's Hospital

Ljubljana, SI-1000, Slovenia

Location

Related Publications (4)

• Biester T, Nir J, Remus K, Farfel A, Muller I, Biester S, Atlas E, Dovc K, Bratina N, Kordonouri O, Battelino T, Philip M, Danne T, Nimri R. DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home. Diabetes Obes Metab. 2019 Apr;21(4):822-828. doi: 10.1111/dom.13585. Epub 2018 Dec 21.

  PMID: 30478937 DERIVED

• Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.

  PMID: 25078901 DERIVED

• Nimri R, Danne T, Kordonouri O, Atlas E, Bratina N, Biester T, Avbelj M, Miller S, Muller I, Phillip M, Battelino T. The "Glucositter" overnight automated closed loop system for type 1 diabetes: a randomized crossover trial. Pediatr Diabetes. 2013 May;14(3):159-67. doi: 10.1111/pedi.12025. Epub 2013 Feb 28.

  PMID: 23448393 DERIVED

• Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N, Miller S, Biester T, Stefanija MA, Muller I, Nimri R, Danne T. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28;368(9):824-33. doi: 10.1056/NEJMoa1206881.

  PMID: 23445093 DERIVED

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

• Moshe Phillip, Prof

  Schenider Children's Medical

  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: November 9, 2010
• First Posted: November 10, 2010
• Study Start: March 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

SL (1); DE (1); IL (1)