Trial Outcomes & Findings for Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes (NCT NCT00211510)

NCT ID: NCT00211510

Last Updated: 2017-06-12

Results Overview

Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 146 participants
• Primary outcome timeframe: Baseline and 26 weeks
• Results posted on: 2017-06-12

Participant Flow

Participant milestones

Measure	Paradigm 722 Sensor Augmented Pump subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump subjects with use the Paradigm 715 insulin pump for insulin infusion
Overall Study STARTED	72	74
Overall Study COMPLETED	66	72
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Measure	Paradigm 722 Sensor Augmented Pump subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump subjects with use the Paradigm 715 insulin pump for insulin infusion
Overall Study Physician Decision	3	1
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Paradigm 722 Sensor Augmented Pump n=72 Participants subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 Participants subjects will use the Paradigm 715 insulin pump for insulin infusion	Total n=146 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 14.6 • n=5 Participants	32.9 years STANDARD_DEVIATION 16.3 • n=7 Participants	32.4 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	46 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	74 participants n=7 Participants	146 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 26 weeks

Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.

Outcome measures

Measure	Paradigm 722 Sensor Augmented Pump n=72 Participants subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 Participants subjects will use the Paradigm 715 insulin pump for insulin infusion
Change in A1c From Baseline to 26 Weeks	-0.72 Percent glycated hemoglobin Standard Deviation 0.69	-0.58 Percent glycated hemoglobin Standard Deviation 0.73

SECONDARY outcome

Timeframe: Baseline and 26 weeks

Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.

Outcome measures

Measure	Paradigm 722 Sensor Augmented Pump n=72 Participants subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 Participants subjects will use the Paradigm 715 insulin pump for insulin infusion
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26	11 hypoglycemic events	3 hypoglycemic events

SECONDARY outcome

Timeframe: Baseline and 26 weeks

Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26

Outcome measures

Measure	Paradigm 722 Sensor Augmented Pump n=72 Participants subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 Participants subjects will use the Paradigm 715 insulin pump for insulin infusion
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26	-0.07 mmol/dl*min Standard Deviation 0.581	0.281 mmol/dl*min Standard Deviation 1.023

SECONDARY outcome

Timeframe: Baseline and 26 weeks

Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26

Outcome measures

Measure	Paradigm 722 Sensor Augmented Pump n=72 Participants subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 Participants subjects will use the Paradigm 715 insulin pump for insulin infusion
Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26	-10.2 mmol/dl*min Standard Deviation 18.6	-9.2 mmol/dl*min Standard Deviation 16.2

SECONDARY outcome

Timeframe: Baseline and 26 weeks

Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).

Outcome measures

Measure	Paradigm 722 Sensor Augmented Pump n=72 Participants subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 Participants subjects will use the Paradigm 715 insulin pump for insulin infusion
Glucose Sensor Accuracy as Measured in the 722 Group	95.9 percent of agreement	NA percent of agreement Subjects in the Paradigm 715 arm did not wear the sensor and so no sensor accuracy could be tested.

SECONDARY outcome

Timeframe: Baseline and 26 weeks

Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.

Outcome measures

Measure	Paradigm 722 Sensor Augmented Pump n=72 Participants subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 Participants subjects will use the Paradigm 715 insulin pump for insulin infusion
Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups	-0.07 Scores on a scale Standard Deviation 0.64	-0.22 Scores on a scale Standard Deviation 0.66

Adverse Events

Paradigm 722 Sensor Augmented Pump

Serious events: 14 serious events

Other events: 25 other events

Deaths: 0 deaths

Paradigm 715 Insulin Pump

Serious events: 8 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paradigm 722 Sensor Augmented Pump n=72 participants at risk subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 participants at risk subjects will use the Paradigm 715 insulin pump for insulin infusion
Endocrine disorders Severe Hypoglycemia	13.9% 10/72 • Number of events 15 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	4.1% 3/74 • Number of events 6 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Endocrine disorders Diabetic Ketoacidosis	4.2% 3/72 • Number of events 3 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	1.4% 1/74 • Number of events 1 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Infections and infestations Skin abscess	1.4% 1/72 • Number of events 2 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	0.00% 0/74 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Eye disorders Retinal detachment	0.00% 0/72 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	1.4% 1/74 • Number of events 1 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Immune system disorders anaphylactic reaction	0.00% 0/72 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	1.4% 1/74 • Number of events 1 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Musculoskeletal and connective tissue disorders scoliosis	0.00% 0/72 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	1.4% 1/74 • Number of events 1 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Injury, poisoning and procedural complications Puncture wound	0.00% 0/72 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	1.4% 1/74 • Number of events 1 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.

Other adverse events

Measure	Paradigm 722 Sensor Augmented Pump n=72 participants at risk subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring	Paradigm 715 Insulin Pump n=74 participants at risk subjects will use the Paradigm 715 insulin pump for insulin infusion
Vascular disorders Haemorrhage	6.9% 5/72 • Number of events 8 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	4.1% 3/74 • Number of events 7 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Skin and subcutaneous tissue disorders Skin Irritation	18.1% 13/72 • Number of events 15 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	5.4% 4/74 • Number of events 5 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
Infections and infestations Infection	5.6% 4/72 • Number of events 4 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	0.00% 0/74 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.
General disorders Pain	4.2% 3/72 • Number of events 4 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.	0.00% 0/74 • Severe adverse event data and adverse device effects were collected for the six month study phase and six month continuation phase that followed. Some hypoglycemia events were self reported and unable to be independently evaluated or verified by the PI, while others had supporting clinical data. Those with supporting data are reported as Systematic, while the self reported events are reported as Non-systematic.

Additional Information

John Shin, PhD, MBA

Medtronic, Inc

Phone: 818 576 4019

Email: john.shin@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60