Overnight MD-Logic
This study is currently recruiting participants.
Verified November 2012 by Rabin Medical Center
Sponsor:
Rabin Medical Center
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01238406
First received: November 9, 2010
Last updated: April 21, 2013
Last verified: November 2012
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Purpose
Study design: Multicenter,randomized, prospective, open label, cross over, five 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, 26 patients will be enrolled at the Israeli center only and 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 6-11 patients will participate in two consecutive24-48 hours sessions,one under closed loop control and the second under sensor augmented pump therapy
1 Diabetes using insulin pump therapy. On the fifth segment up to 30 eligible patients will be enrolled at the Israeli center only. Each subject will participate in 3 months period of overnights ether using closed-loop with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 3 months of the study, statistical analysis will be performed in order to decide whether to extend the study with an optional period of extra 3 months.In case it will be decided to extend the study, additional 3 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 3 months of closed-loop control and the study group will be offered to switch to sensor augmented pump therapy
Objectives: The objective of this feasibility study is to evaluate the safety and efficacy of blood glucose control overnight using the MD-Logic Artificial Pancreas System in individuals with type 1 diabetes both in the hospital settings,at a diabetes camp and finally at patient's home.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Device: MD-logic Artificial Pancreas (MDLAP) Device: Standard treatment with insulin pump |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter, Prospective, Open Label, Cross Over, 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 |
Resource links provided by NLM:
Further study details as provided by Rabin Medical Center:
Primary Outcome Measures:
- Number of hypoglycemic events [ Time Frame: 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) ] [ Designated as safety issue: Yes ]Number of overnight hypoglycemic events below 63 mg/dl, between bed time to 07:00
- Time spent in hypoglycemia [ Time Frame: final visit (day 26 for participants at segment 1 , day 14 for participants in segment 2 and day 20 for participants in segment 3, 6 months for participants in segment 5) ] [ Designated as safety issue: Yes ]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
- Reduction in overnight mean glucose level [ Time Frame: final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2) ] [ Designated as safety issue: No ]Reduction in overnight mean glucose level
- Increase in time spent in the target range [ Time Frame: day 14 for participants in segment 4 ] [ Designated as safety issue: No ]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)
Secondary Outcome Measures:
- Percentage of time spent in the target range [ Time Frame: 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) ] [ Designated as safety issue: No ]Percentage of time spent in the target range,defined as sensor glucose level within 63 to 140 mg/dl (3.5 to 7.8 mmol/l)and between 70 to 140 mg/dl(3.9 to 7.8 mmol/L)
- Percentage of time spent in the tight target range [ Time Frame: 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) ] [ Designated as safety issue: No ]Percentage of time spent in the target range, defined as sensor glucose level within 80 to 120 mg/dl (3.5 to 7.8 mmol/l)
- Average (SD) of blood glucose levels [ Time Frame: final visit (day 26 for participants at segment 1and 4 and day 14 for participants in segment 2 and day 20 for participants in segment 3) ] [ Designated as safety issue: No ]Average (SD) of blood glucose levels
- Percentage of time spent below 60 mg/dl and below 70 mg/dl [ Time Frame: 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) ] [ Designated as safety issue: Yes ]Percentage of time spent below 60 mg/dl and below 70 mg/dl
- Percentage of time spent above 140, 180, 250 mg/dl (7.8, 10, 13.9 mmol/l) [ Time Frame: 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 ) ] [ Designated as safety issue: No ]Percentage of time spent above 140, 180, 250 mg/dl (7.8, 10, 13.9 mmol/l)
- Glucose variability [ Time Frame: 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 ) ] [ Designated as safety issue: No ]Glucose variability
- Control Variability Grid Analysis (CVGA) [ Time Frame: final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2) ] [ Designated as safety issue: No ]Control Variability Grid Analysis (CVGA)
- number of accurate alerts related to the remote safety and control diabetes management system [ Time Frame: final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2) ] [ Designated as safety issue: Yes ]number of accurate alerts related to the remote safety and control diabetes management system
- Number of hypoglycemic events below 60 and 70 mg/dl (3.3, 3.9 mmol/l) [ Time Frame: 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) ] [ Designated as safety issue: Yes ]Number of hypoglycemic events below 60 and 70 mg/dl (3.3, 3.9 mmol/l)
- Area under the curve <60,<63,<70,>140,>180,>250 mg/dl(3.3,3.5,3.9,7.8,10,13.9) [ Time Frame: 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) ] [ Designated as safety issue: No ]Area under the curve <60,<63,<70,>140,>180,>250 mg/dl(3.3,3.5,3.9,7.8,10,13.9)
- • The percentage of nights mean overnight sensor glucose levels was within 90-140mg/dl (5-7.8 mmol/l) [ Time Frame: final visit (day 14 ) for participants in segment 4 only ] [ Designated as safety issue: No ]
- Postprandial peak blood glucose and 2 hours postprandial blood glucose (segment 4 only) [ Time Frame: Final visit (day 14 ) for participants in segment 4 only ] [ Designated as safety issue: No ]
- Artificial Pancreas technical performance, defined as the total frequency of failures [ Time Frame: Final visit (day 14 ) for participants in segment 4 only ] [ Designated as safety issue: No ]Artificial Pancreas technical performance, defined as The total frequency of failures (number of failures/night) of each following system components: sensor communication, pump communication, controller, user interface
- Analysis of the number of sensor data point not received to the artificial pancreas device divided by the total number of possible data points to be received. [ Time Frame: Final visit (day 14 ) for participants in segment 4 only ] [ Designated as safety issue: No ]
- Percent time of active closed-loop control [ Time Frame: Final visit (day 14) for participants in segment 4 only ] [ Designated as safety issue: No ]Percent time of active closed-loop control defined as the number of minutes the MD-Logic system was functioning properly (computation of insulin infusion, and insulin actually delivered) divided by the maximum number of minutes the MD-Logic system should have been active (as per protocol)
- sensor accuracy [ Time Frame: final visit (day 14 for participants in segment 4 only) ] [ Designated as safety issue: No ]comparison of paired data points between capillary glucose level and Continuous Glucose Monitoring
- The time spent in hypoglycemia and the mean area under the curve [ Time Frame: After 6 month at segment 5 only ] [ Designated as safety issue: Yes ]The time spent in hypoglycemia and the mean area under the curve (AUC) below 60 and 50 mg/dl (3.3 and 2.8 mmol/l).
- The number of hypoglycemic events below 60 and 50 mg/dl [ Time Frame: After 6 months only at segment 5 ] [ Designated as safety issue: Yes ]The number of hypoglycemic events below 60 and 50 mg/dl (event defined duration of at least 20 minutes).
- The time sensor glucose level spent within 70 to 140 mg/dl (3.9 to 7.8 mmol/l) [ Time Frame: After 6 months only at segment 5 ] [ Designated as safety issue: No ]
- Glucose variability [ Time Frame: After 6 months only at segment 5 ] [ Designated as safety issue: No ]Glucose variability measured by coefficient of variation (CV%) and Kovatchev indexes
- The time spent in hyperglycemia and the mean area under the curve [ Time Frame: After 6 monts only at segment 5 ] [ Designated as safety issue: Yes ]The time spent in hyperglycemia and the mean area under the curve (AUC) above 180 mg/dl (10 mmol/l) and 240 mg/dl (13.3 mmol/l).
- Patient's diabetes treatment satisfaction [ Time Frame: After 6 months only at segment 5 ] [ Designated as safety issue: No ]Patient's diabetes treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire
- Acceptance and use intention of an Artificial Pancreas [ Time Frame: after 6 months only at segment 5 ] [ Designated as safety issue: No ]Acceptance and use intention of an Artificial Pancreas for participant and for parents
- Fear of hypoglycemia [ Time Frame: After 6 months only at segment 5 ] [ Designated as safety issue: No ]Fear of hypoglycemia using questionaire
- Satisfaction with Artificial Pancreas [ Time Frame: After 6 months only at segment 5 ] [ Designated as safety issue: No ]Satisfaction with Artificial Pancreas using questionaire
- The total frequency of failures [ Time Frame: after 6 months only at segment 5 ] [ Designated as safety issue: Yes ]The total frequency of failures (#failures/night) of each of the system components
- Average percentage of overnight operation of the closed-loop control [ Time Frame: After 6 months only at segment 5 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 108 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MD-logic Artificial Pancreas (MDLAP) system
Inpatient Overnight use of the closed loop MD-logic Artificial Pancreas(MDLAP)System
|
Device: MD-logic Artificial Pancreas (MDLAP)
Inpatient overnight session using the closed loop MD-logic Artificial Pancreas(MDLAP)System
|
|
Active Comparator: Standard treatment with insulin pump
Inpatient overnight session using standard treatment with continuous subcutaneous insulin infusion
|
Device: Standard treatment with insulin pump
Inpatient overnight session using standard treatment with continuous subcutaneous insulin infusion
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 10 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- HbA1c at inclusion ≥ 7 and <10 who have more than 1% of time spent below 60 mg/dl (average sensor data per week)
- Patients willing to follow trail instructions
- Patients live with at least one other adult person (segment 3 and 5 only)
- BMI Standard Deviation Score - below the 97th percentile for age(in segment 5 BMI SDS - below the 95th percentile for age)
- An internet connection at patient's home (only for patients participating at segment 3 and 5)
- Patients with care givers who are capable of operating a computer based system
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238406
Contacts
| Contact: Moshe Phillip, Prof | 972-3-9253747 | mosheph@clalit.org.il |
| Contact: Alona Hamou, Msc | 972-3-9253778 | alonah@clalit.org.il |
Locations
| Germany | |
| Diabetes -Zentrum fuer kinder und jugendliche | Active, not recruiting |
| Hannover, Germany, 30173 | |
| Israel | |
| Schneider Children's Medical center | Recruiting |
| Petach-Tikva, Israel, 49202 | |
| Contact: Moshe Phillip, Prof 972-3-9253747 mosheph@clalit.org.il | |
| Principal Investigator: Moshe Phillip, Prof | |
| Sub-Investigator: Revital Nimri, Dr | |
| Sub-Investigator: Eran Atlas, Msc | |
| Sub-Investigator: Eli A Grunberg, Bsc | |
| Sub-Investigator: Shahar Miller, Bsc | |
| Sub-Investigator: Shlomit Shalitin, Dr | |
| Sub-Investigator: Yael Lebenthal, Dr | |
| Sub-Investigator: Liora Lazar, Dr. | |
| Sub-Investigator: Liat de Vries, Dr | |
| Sub-Investigator: Tal Ben Ari, Dr | |
| Sub-Investigator: Tal Oron, Dr | |
| Sub-Investigator: Ariel Tenenbaum, Dr | |
| Sub-Investigator: Eran Mel, Dr | |
| Sub-Investigator: Nitzan Dror, Dr | |
| Sub-Investigator: Alon Pharfel, Dr | |
| Slovenia | |
| University Children's Hospital | Active, not recruiting |
| Ljubljana, Slovenia, SI-1000 | |
Sponsors and Collaborators
Rabin Medical Center
Investigators
| Principal Investigator: | Moshe Phillip, Prof | Schenider Children's Medical |
More Information
No publications provided by Rabin Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT01238406 History of Changes |
| Other Study ID Numbers: | rmc006000ctil |
| Study First Received: | November 9, 2010 |
| Last Updated: | April 21, 2013 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rabin Medical Center:
|
Type 1 diabetes Closed loop Artificial Pancreas |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Insulin |
Pancreatin Pancrelipase Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013