We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With 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: NCT02660827
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : January 11, 2019
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Device: Insulin Pump
Enrollment 151
Recruitment Details 151 subjects aged 2-13 years entered study period, 1 subject withdrawn during study period, 5 subjects didn't participate continued access period after finishing study period; 145 subjects aged 2-13 years entered continued access period, 25 subjects withdrawn and 120 subjects completed continued access period.
Pre-assignment Details 2-13 years subjects wearing MMT-670G insulin pump
Arm/Group Title Subjects Wearing MMT-670G Insulin Pump
Hide Arm/Group Description Subjects wearing MMT- 670G insulin pump during Study and Continued Access period
Period Title: From Study to End of Continued Access
Started 151
Completed 120
Not Completed 31
Reason Not Completed
Withdrawal by Subject             21
Withdrawal by Sponsor             2
Adverse Event             3
didn't participate continued access period             5
Period Title: Period 1: Study Period
Started 151
Completed 150
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: Period 2: Continued Access Period
Started 145
Completed 120
Not Completed 25
Reason Not Completed
Withdrawal by Subject             20
Withdrawal by Sponsor             2
Adverse Event             3
Arm/Group Title Age 2-13 Yrs
Hide Arm/Group Description Age 2-13 Yrs Subjects wearing MMT- 670G insulin pump
Overall Number of Baseline Participants 151
Hide Baseline Analysis Population Description
2-13 Years old subjects wearing MMT-670G insulin pump
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants
8.9  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Female
69
  45.7%
Male
82
  54.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
American Indian or Alaska Native
1
   0.7%
Asian
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   3.3%
White
132
  87.4%
More than one race
0
   0.0%
Unknown or Not Reported
11
   7.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 151 participants
140
Israel Number Analyzed 151 participants
11
BMI (kg/m2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 150 participants
18.4  (3.8)
[1]
Measure Analysis Population Description: One Subject's height and weight were not measured at enrollment.
1.Primary Outcome
Title Age 2-13 Years Old Subjects Change in A1C
Hide Description Descriptive analysis of change in A1C from baseline to end of 3-month study period
Time Frame Baseline and end of 3-month study period
Hide Outcome Measure Data
Hide Analysis Population Description
2-13 years old subjects wearing MMT-670G insulin pump; two subjects end of study A1C not collected.
Arm/Group Title Age 2-13 Years Old Wearing MMT-670G Insulin Pump
Hide Arm/Group Description:
2-13 years old subjects wearing MMT-670G insulin pump.
Overall Number of Participants Analyzed 149
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin
-0.37  (0.62)
2.Secondary Outcome
Title Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL)
Hide Description mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
2-13 years old subjects wearing MMT-670G insulin pump.
Arm/Group Title Age 2-13 Years Old Wearing the MMT-670G Insulin Pump
Hide Arm/Group Description:
2-13 years old subjects wearing MMT-670G insulin pump.
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: Percentage of time
8.58  (8.84)
3.Secondary Outcome
Title Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)
Hide Description mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months study period
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
2-13 years old subjects wearing MMT-670G insulin pump.
Arm/Group Title Age 2-13 Years Old Wearing the MMT-670G Insulin Pump
Hide Arm/Group Description:
2-13 years old subjects wearing MMT-670G insulin pump.
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: Percent of time
-7.39  (9.96)
4.Secondary Outcome
Title Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)
Hide Description mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months study period
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
2-13 years old subjects wearing MMT-670G insulin pump.
Arm/Group Title Age 2-13 Years Old Wearing the MMT-670G Insulin Pump
Hide Arm/Group Description:
2-13 years old subjects wearing MMT-670G insulin pump.
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: percent of time
-1.19  (2.58)
5.Secondary Outcome
Title Age 2-13 Years Old - Number of Severe Hypoglycemic Event
Hide Description Number of severe hypoglycemic events occurred during 3-month study period.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
2-13 years old subjects wearing MMT-670G insulin pump.
Arm/Group Title Age 2-13 Years Old Wearing the MMT-670G Insulin Pump
Hide Arm/Group Description:
2-13 years old subjects wearing MMT-670G insulin pump.
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: events
0
6.Secondary Outcome
Title Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event
Hide Description Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
2-13 years old subjects wearing MMT-670G insulin pump.
Arm/Group Title Age 2-13 Years Old Wearing the MMT-670G Insulin Pump
Hide Arm/Group Description:
2-13 years old subjects wearing MMT-670G insulin pump.
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: events
0
7.Secondary Outcome
Title Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL
Hide Description Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures.
Time Frame Up to 12 hours after the start of PLGM period
Hide Outcome Measure Data
Hide Analysis Population Description
7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.
Arm/Group Title Age 7-13 Years Old Wearing the MMT-670G Insulin Pump
Hide Arm/Group Description:
7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: percentage of total experiments
84.8
Time Frame 3 months for Study period, up to 3 years for Continued Access period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age 2-13 Yrs Study Period Age 2-13 Yrs Continued Access Period
Hide Arm/Group Description 2-13 years old subjects wearing MMT-670G insulin pump during Study period. 2-13 years old subjects wearing MMT-670G insulin pump during Continued Access period.
All-Cause Mortality
Age 2-13 Yrs Study Period Age 2-13 Yrs Continued Access Period
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)      0/145 (0.00%)    
Hide Serious Adverse Events
Age 2-13 Yrs Study Period Age 2-13 Yrs Continued Access Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/151 (0.00%)      4/145 (2.76%)    
Infections and infestations     
Gastroenteritis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Metabolism and nutrition disorders     
Hyperglycaemia  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Diabetic ketoacidosis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Nervous system disorders     
Hypoglycaemic seizure  1  0/151 (0.00%)  0 1/145 (0.69%)  1
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Age 2-13 Yrs Study Period Age 2-13 Yrs Continued Access Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   88/151 (58.28%)      113/145 (77.93%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Ear and labyrinth disorders     
Cerumen impaction  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Ear pain  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/151 (0.00%)  0 3/145 (2.07%)  3
Abdominal pain upper  1  2/151 (1.32%)  2 2/145 (1.38%)  2
Coeliac disease  1  0/151 (0.00%)  0 4/145 (2.76%)  4
Constipation  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Diarrhoea  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Gastrointestinal disorder  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Mouth ulceration  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Nausea  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Vomiting  1  2/151 (1.32%)  2 5/145 (3.45%)  5
General disorders     
Ill-defined disorder  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Influenza like illness  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Infusion site haemorrhage  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Injury associated with device  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Medical device site rash  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Medical device site reaction  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Pain  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Pyrexia  1  2/151 (1.32%)  2 7/145 (4.83%)  7
Immune system disorders     
Food allergy  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Seasonal allergy  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Infections and infestations     
Abscess limb  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Breast cellulitis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Bronchitis  1  1/151 (0.66%)  1 2/145 (1.38%)  2
Cellulitis  1  2/151 (1.32%)  2 3/145 (2.07%)  3
Conjunctivitis  1  0/151 (0.00%)  0 6/145 (4.14%)  6
Croup infectious  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Dacryocanaliculitis  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Ear infection  1  1/151 (0.66%)  1 6/145 (4.14%)  8
Erythema infectiosum  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Folliculitis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Gastroenteritis  1  7/151 (4.64%)  8 15/145 (10.34%)  17
Gastroenteritis viral  1  1/151 (0.66%)  1 6/145 (4.14%)  10
Gastrointestinal infection  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Gastrointestinal viral infection  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Hand-foot-and-mouth disease  1  0/151 (0.00%)  0 3/145 (2.07%)  3
Herpangina  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Herpes zoster  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Impetigo  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Infectious mononucleosis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Influenza  1  2/151 (1.32%)  2 7/145 (4.83%)  8
Infusion site infection  1  1/151 (0.66%)  1 5/145 (3.45%)  5
Medical device site abscess  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Medical device site infection  1  2/151 (1.32%)  2 0/145 (0.00%)  0
Molluscum contagiosum  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Nasopharyngitis  1  5/151 (3.31%)  5 8/145 (5.52%)  12
Oral candidiasis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Otitis externa  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Otitis media  1  0/151 (0.00%)  0 5/145 (3.45%)  5
Otitis media acute  1  0/151 (0.00%)  0 5/145 (3.45%)  6
Periumbilical abscess  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Pharyngitis  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Pharyngitis streptococcal  1  2/151 (1.32%)  2 14/145 (9.66%)  15
Pneumonia  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Rhinovirus infection  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Scarlet fever  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Sinusitis  1  1/151 (0.66%)  1 6/145 (4.14%)  7
Skin infection  1  0/151 (0.00%)  0 2/145 (1.38%)  3
Staphylococcal abscess  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Subcutaneous abscess  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Tonsillitis  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Tonsillitis streptococcal  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Tooth abscess  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Tooth infection  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Upper respiratory tract infection  1  8/151 (5.30%)  8 20/145 (13.79%)  28
Urinary tract infection  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Viral infection  1  5/151 (3.31%)  5 8/145 (5.52%)  9
Viral pharyngitis  1  1/151 (0.66%)  1 2/145 (1.38%)  2
Viral upper respiratory tract infection  1  1/151 (0.66%)  1 6/145 (4.14%)  6
Injury, poisoning and procedural complications     
Arthropod bite  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Avulsion fracture  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Concussion  1  0/151 (0.00%)  0 3/145 (2.07%)  4
Contusion  1  1/151 (0.66%)  2 0/145 (0.00%)  0
Foot fracture  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Foreign body  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Greenstick fracture  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Hand fracture  1  1/151 (0.66%)  1 3/145 (2.07%)  3
Humerus fracture  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Joint injury  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Ligament sprain  1  2/151 (1.32%)  2 4/145 (2.76%)  4
Limb injury  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Meniscus injury  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Radius fracture  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Scar  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Skin abrasion  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Skin laceration  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Torus fracture  1  1/151 (0.66%)  1 2/145 (1.38%)  2
Upper limb fracture  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Wrist fracture  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Investigations     
Blood ketone body increased  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Helicobacter test positive  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Metabolism and nutrition disorders     
Acetonaemia  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Dehydration  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Diabetic ketoacidosis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Hyperglycaemia  1  56/151 (37.09%)  146 70/145 (48.28%)  372
Hypoglycaemia  1  1/151 (0.66%)  1 5/145 (3.45%)  5
Ketosis  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Musculoskeletal pain  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Osteochondrosis  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Pain in extremity  1  1/151 (0.66%)  1 5/145 (3.45%)  5
Scoliosis  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Temporomandibular joint syndrome  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Nervous system disorders     
Headache  1  4/151 (2.65%)  4 2/145 (1.38%)  2
Migraine  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Presyncope  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Syncope  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Psychiatric disorders     
Attention deficit hyperactivity disorder  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Depression  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Cough  1  1/151 (0.66%)  1 6/145 (4.14%)  7
Dyspnoea  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Laryngeal oedema  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Nasal congestion  1  3/151 (1.99%)  3 1/145 (0.69%)  1
Nasal polyps  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Oropharyngeal pain  1  1/151 (0.66%)  1 4/145 (2.76%)  4
Rhinitis allergic  1  0/151 (0.00%)  0 2/145 (1.38%)  2
Sleep apnoea syndrome  1  1/151 (0.66%)  1 1/145 (0.69%)  1
Upper respiratory tract congestion  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Skin and subcutaneous tissue disorders     
Acne  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Alopecia  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Dermatitis  1  2/151 (1.32%)  2 2/145 (1.38%)  2
Dermatitis allergic  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Dermatitis contact  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Eczema  1  2/151 (1.32%)  3 0/145 (0.00%)  0
Erythema  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Lipoatrophy  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Pityriasis rosea  1  0/151 (0.00%)  0 1/145 (0.69%)  1
Rash  1  1/151 (0.66%)  1 5/145 (3.45%)  5
Rash maculo-papular  1  1/151 (0.66%)  1 0/145 (0.00%)  0
Skin irritation  1  5/151 (3.31%)  5 1/145 (0.69%)  1
Urticaria  1  0/151 (0.00%)  0 1/145 (0.69%)  1
1
Term from vocabulary, MedDRA23.0
Indicates events were collected by 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: Vivian Chen, Statistician
Organization: Medtronic Minimed
Phone: 8185763309
EMail: vivian.chen@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02660827    
Other Study ID Numbers: CEP 302
First Submitted: January 16, 2016
First Posted: January 21, 2016
Results First Submitted: October 22, 2018
Results First Posted: January 11, 2019
Last Update Posted: January 26, 2022