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In Clinic Evaluation of the PLGM Feature (PLGM)

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ClinicalTrials.gov Identifier: NCT02130284
Recruitment Status : Completed
First Posted : May 5, 2014
Results First Posted : April 4, 2017
Last Update Posted : September 28, 2017
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: Predictive Low Glucose Management Feature in Insulin pump
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Period Title: Overall Study
Started 80
Completed 71
Not Completed 9
Reason Not Completed
Withdrawal by Subject             3
Subject Withdrew Consent             1
Subject's sensor failed at Visit 2, Day             1
Subject was screened as backup for study             3
Screen Failure             1
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
<=18 years
14
  17.5%
Between 18 and 65 years
63
  78.8%
>=65 years
3
   3.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
35.0  (16.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
45
  56.3%
Male
35
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants
80
1.Primary Outcome
Title Serious Adverse Events (SAE)
Hide Description Evaluation of incidence of SAE during in-clinic procedures
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Unanticipated Device Effect (UADE)
Hide Description Evaluation of incidence of UADE during in-clinic procedures
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title Severe Hypoglycemia
Hide Description Evaluation of incidence of severe hypoglycemia during in-clinic procedures
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Primary Outcome
Title Diabetic Ketoacidosis
Hide Description Evaluation of DKA during in-clinic procedures
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Primary Outcome
Title Rescue Events During In-clinic Procedues
Hide Description [Not Specified]
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
7
   8.8%
6.Other Pre-specified Outcome
Title PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.
Hide Description Hypoglycemic event rate among 71 subjects who underwent the PLGM experiment. Hypoglycemic events are defined based on: occurrence of 2 or more continuous YSI <= 65 mg/dL during in-clinic procedures.
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects were excluded from analysis because the site staff did not set the pump up correctly prior to YSI and the PLGM feature was never set to activate.
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of total subjects
39.13
7.Other Pre-specified Outcome
Title Sensor Performance: Accuracy
Hide Description MARD (Mean Absolute Relative Difference) between sensor glucose value and YSI. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total of 71 subjects completed the study. However, two subjects who withdrew also had YSI and Sensor glucose values. Therefore, total of 73 subjects contributed to sensor accuracy analysis
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: percentage
12.56  (10.06)
8.Other Pre-specified Outcome
Title Device Metric/Performance - All Device Deficiencies
Hide Description [Not Specified]
Time Frame From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description:

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: device performance issues
13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Predictive Low Glucose Management (PLGM)
Hide Arm/Group Description

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

All-Cause Mortality
Predictive Low Glucose Management (PLGM)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Predictive Low Glucose Management (PLGM)
Affected / at Risk (%) # Events
Total   0/80 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Predictive Low Glucose Management (PLGM)
Affected / at Risk (%) # Events
Total   5/80 (6.25%)    
Gastrointestinal disorders   
emesis   1/80 (1.25%)  1
General disorders   
pain   1/80 (1.25%)  1
Infections and infestations   
Upper respiratory infection   1/80 (1.25%)  1
Injury, poisoning and procedural complications   
Mild back strain   1/80 (1.25%)  1
Nervous system disorders   
headache   1/80 (1.25%)  1
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
Name/Title: Suiying Huang, Statistician
Organization: Medtronic Minimed
Phone: 818-576-3319
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02130284     History of Changes
Other Study ID Numbers: CEP 272 PLGM
First Submitted: April 18, 2014
First Posted: May 5, 2014
Results First Submitted: February 14, 2017
Results First Posted: April 4, 2017
Last Update Posted: September 28, 2017