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Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02463097
Recruitment Status : Completed
First Posted : June 4, 2015
Results First Posted : April 18, 2017
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Device: Insulin Pump
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Arm
Hide Arm/Group Description

All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Insulin Pump: Closed Loop Algorithm

i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation

Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required

Period Title: Overall Study
Started 124
Completed 123
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Study Arm
Hide Arm/Group Description

All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Insulin Pump: Closed Loop Algorithm

i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation

Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required

Overall Number of Baseline Participants 124
Hide Baseline Analysis Population Description
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
<=18 years
22
  17.7%
Between 18 and 65 years
96
  77.4%
>=65 years
6
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants
37.8  (16.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
Female
69
  55.6%
Male
55
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 124 participants
United States 112
Israel 12
1.Primary Outcome
Title Change in A1C
Hide Description There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Arm
Hide Arm/Group Description:

All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Insulin Pump: Closed Loop Algorithm

i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation

Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required

Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: Percent
-0.5  (0.6)
2.Secondary Outcome
Title Number of Severe Hypoglycemia Events
Hide Description There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Arm
Hide Arm/Group Description:

All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Insulin Pump: Closed Loop Algorithm

i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation

Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required

Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: events
0
3.Secondary Outcome
Title Number of Diabetic Ketoacidosis (DKA) Events
Hide Description There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Arm
Hide Arm/Group Description:

All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Insulin Pump: Closed Loop Algorithm

i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation

Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required

Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: events
0
Time Frame 3 Month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Arm
Hide Arm/Group Description

All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Insulin Pump: Closed Loop Algorithm

i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation

Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required

All-Cause Mortality
Study Arm
Affected / at Risk (%)
Total   0/124 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Study Arm
Affected / at Risk (%) # Events
Total   2/124 (1.61%)    
Infections and infestations   
Appendicitis * 1  1/124 (0.81%)  1
Bacterial arthritis of right wrist * 1  1/124 (0.81%)  1
Investigations   
C-difficile diarrhea * 1  1/124 (0.81%)  1
Musculoskeletal and connective tissue disorders   
Worsening Rheumatoid Arthritis * 1  1/124 (0.81%)  1
1
Term from vocabulary, MedDRA15.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Arm
Affected / at Risk (%) # Events
Total   66/124 (53.23%)    
Ear and labyrinth disorders   
Benign paroxysmal positional vertigo * 1  1/124 (0.81%)  1
Eye disorders   
Cataract * 1  1/124 (0.81%)  1
Conjunctivitis * 1  1/124 (0.81%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/124 (0.81%)  1
Abdominal pain for few days * 1  1/124 (0.81%)  1
Dyspepsia * 1  1/124 (0.81%)  1
Emesis * 1  1/124 (0.81%)  1
Gastro pain (upset stomach), nausea * 1  1/124 (0.81%)  1
Heart burn * 1  1/124 (0.81%)  1
Toothache * 1  1/124 (0.81%)  1
Vomiting * 1  1/124 (0.81%)  1
General disorders   
Infiltration. bruising. * 1  1/124 (0.81%)  1
Irritation on sensor site * 1  1/124 (0.81%)  1
Iv site pain * 1  1/124 (0.81%)  1
Pain * 1  1/124 (0.81%)  1
Immune system disorders   
Type 4 skin hypersensitivity * 1  1/124 (0.81%)  1
Infections and infestations   
Acute frontal sinusitis * 1  1/124 (0.81%)  1
Bacterial conjunctivitis * 1  1/124 (0.81%)  1
Bronchitis * 1  2/124 (1.61%)  2
Cold * 1  4/124 (3.23%)  5
Cold-upper respiratory * 1  1/124 (0.81%)  1
Common cold * 1  5/124 (4.03%)  5
Gastroenteritis * 1  3/124 (2.42%)  3
Gastrointestinal virus * 1  1/124 (0.81%)  1
Head cold * 1  3/124 (2.42%)  3
Intestinal virus * 1  1/124 (0.81%)  1
Laryngitis * 1  1/124 (0.81%)  1
Left leg cellulitis * 1  1/124 (0.81%)  1
Mononucleosis * 1  1/124 (0.81%)  1
Otitis media * 1  1/124 (0.81%)  1
Periodontal infection * 1  1/124 (0.81%)  1
Pharyngitis * 1  1/124 (0.81%)  1
Sinus infection * 1  1/124 (0.81%)  1
Stomach flu * 1  1/124 (0.81%)  1
Upper respiratory infection * 1  11/124 (8.87%)  13
Upper respiratory tract infection * 1  3/124 (2.42%)  3
Urinary tract infection * 1  1/124 (0.81%)  1
Uti * 1  2/124 (1.61%)  2
Viral illness * 1  1/124 (0.81%)  2
Injury, poisoning and procedural complications   
Abrasion to left great toe * 1  1/124 (0.81%)  1
Ankle sprain * 1  1/124 (0.81%)  1
Bicycle injury * 1  1/124 (0.81%)  1
Burn * 1  1/124 (0.81%)  1
Cracked ulna * 1  1/124 (0.81%)  1
Rib fracture * 1  1/124 (0.81%)  1
Metabolism and nutrition disorders   
Hyperglycemia * 1  6/124 (4.84%)  6
Severe hyperglycemia * 1  13/124 (10.48%)  17
Musculoskeletal and connective tissue disorders   
Rheumatoid arthritis * 1  1/124 (0.81%)  1
Nervous system disorders   
Headache * 1  4/124 (3.23%)  5
Intermittent headaches * 1  1/124 (0.81%)  1
Migraine * 1  2/124 (1.61%)  2
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/124 (0.81%)  1
Deviated septum * 1  1/124 (0.81%)  1
Upper respiratory congestion * 1  2/124 (1.61%)  2
Skin and subcutaneous tissue disorders   
Rash * 1  1/124 (0.81%)  1
Skin irritation * 1  1/124 (0.81%)  1
Pruritus * 1  1/124 (0.81%)  1
Vascular disorders   
Thrombophlebitis * 1  1/124 (0.81%)  1
1
Term from vocabulary, MedDRA15.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Thoub
Organization: Medtronic Minimed
Phone: 8185763142
EMail: thomas.troub@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02463097     History of Changes
Other Study ID Numbers: CEP 294
First Submitted: May 28, 2015
First Posted: June 4, 2015
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: April 15, 2019