Post Approval Study of the TS Feature With the 530G Pump... | NCT02003898

Status Module

Label	Type	Description	Intervention Names
Medtronic MiniMed 530G Insulin Pump	Experimental	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.	Device: Medtronic MiniMed 530G Insulin Pump

Name	Type	Description	Arm Group Labels	Other Names
Medtronic MiniMed 530G Insulin Pump	Device		Medtronic MiniMed 530G Insulin Pump

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in A1C From Baseline to 1 Year	Comparison of A1C measurement from baseline to end of study in the CEP266 study population. The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%	Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.	1 year
Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is age 16 or older at time of screening
Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.
Subject is currently on pump therapy.
Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.
Subject is willing to complete all study related activities
Subject is willing to upload data every 21 days from the study pump
Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend's computer system with Internet access.
Subject is able (by insurance or financial means) to cover the initial investment and ongoing cost of the 530G insulin pump and consumables, CGM, Bayer CONTOUR Next Link RF enabled meter and supplies for the length of the study- 1 year.

Exclusion Criteria:

Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks.
Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study
Subject is being treated for hyperthyroidism at time of screening
Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. If TSH is out of range, Free T3 and Free T4 will be tested. Subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range.
Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
Subject is currently abusing illicit drugs
Subject is currently abusing prescription drugs
Subject is currently abusing alcohol
Subject has sickle cell disease or hemoglobinopathy
Subject has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation
Subject diagnosed with current eating disorder such as anorexia or bulimia
Subject has been diagnosed with chronic kidney disease that results in chronic anemia
Subject is on dialysis

Name	Affiliation	Role
Scott Lee, MD	Medtronic MiniMed, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Medical Investigations, Inc.		Little Rock	Arkansas	72205	United States
AMCR Institute

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Medtronic MiniMed 530G Insulin Pump	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 10, 2017	Jan 7, 2019

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00045.5± 15.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000201
Male	BG000171

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00015
Not Hispanic or Latino	BG000351

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000372

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change in A1C From Baseline to 1 Year

Comparison of A1C measurement from baseline to end of study in the CEP266 study population.

The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.

Among the 372 enrolled subjects, 298 had both baseline and end of study A1c.

Posted

Mean

95% Confidence Interval

percentage

1 year

ID	Title	Description
OG000	Medtronic MiniMed 530G Insulin Pump	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump

Units	Counts
Participants	OG000298

Title

Denominators

Categories

Title	Measurements
	OG0000.034(-0.03 to 0.098)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000						Mean Difference (Net)	0.034			2-Sided	95	-0.03	0.098					Non-Inferiority	non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).

Secondary

Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%

Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.

Posted

Mean

Standard Deviation

percentage

1 year

ID	Title	Description
OG000	Medtronic MiniMed 530G Insulin Pump	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump

Units	Counts
Participants	OG00083

Secondary

Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%

Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%

Posted

Mean

Standard Deviation

percentage

1 year

ID	Title	Description
OG000	Medtronic MiniMed 530G Insulin Pump	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump

Units	Counts
Participants	OG000187

Secondary

Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%

Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c > 9%

Posted

Mean

Standard Deviation

percentage

1 year

ID	Title	Description
OG000	Medtronic MiniMed 530G Insulin Pump	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump

Units	Counts
Participants	OG00028

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Altered state of consciousness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Bile duct obstruction	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Cellulitis staphylococcal	Infections and infestations	Systematic Assessment	EG0001 events1 affected372 at risk
Chest pain	General disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Death	General disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0005 events5 affected372 at risk
Gastric ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events4 affected372 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Mixed hepatocellular cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected372 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected372 at risk
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0004 events1 affected372 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected372 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected372 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abscess limb	Infections and infestations	Systematic Assessment	EG0001 events1 affected372 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected372 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events2 affected372 at risk
Convulsion	Nervous system disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Dermatophytosis	Infections and infestations	Systematic Assessment	EG0001 events1 affected372 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG00013 events10 affected372 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events4 affected372 at risk
Infusion site erythema	General disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Infusion site infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected372 at risk
Ketonuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Medical device site reaction	General disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Nerve injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected372 at risk
Puncture site haemorrhage	General disorders	Systematic Assessment	EG00014 events9 affected372 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Scar	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected372 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0001 events1 affected372 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected372 at risk
Skin irritation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected372 at risk

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases