Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data

• Sponsor: Medtronic Diabetes (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02003898
• Collaborator: (none)
• Enrollment: 372
• Locations: 43
• Arm: 1
• Actual Duration (Months): 50.8
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: Medtronic MiniMed 530G Insulin Pump	N/A

Detailed Description

Multi-center trial is initiated to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump (Medtronic MiniMed® 530G insulin pump) in patients 16 and older with insulin requiring diabetes over a period of one year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 372 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All subjects are assigned to treatment with the Medtronic 530G Insulin PumpAll subjects are assigned to treatment with the Medtronic 530G Insulin Pump
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data
• Actual Study Start Date: Nov 26, 2013
• Actual Primary Completion Date: Feb 20, 2018
• Actual Study Completion Date: Feb 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medtronic MiniMed 530G Insulin Pump All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.	Device: Medtronic MiniMed 530G Insulin Pump

Outcome Measures

Primary Outcome Measures

1. Mean Change in A1C From Baseline to 1 Year [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.

Secondary Outcome Measures

1. Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7% [1 year]

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

2. Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9% [1 year]

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

3. Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9% [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is age 16 or older at time of screening

2. Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.

3. Subject is currently on pump therapy.

4. Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.

5. Subject is willing to complete all study related activities

6. Subject is willing to upload data every 21 days from the study pump

7. 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.

8. 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:

1. 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.

2. 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

3. Subject is being treated for hyperthyroidism at time of screening

4. Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit

5. 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.

6. 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

7. Subject is currently abusing illicit drugs

8. Subject is currently abusing prescription drugs

9. Subject is currently abusing alcohol

10. Subject has sickle cell disease or hemoglobinopathy

11. 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

12. Subject diagnosed with current eating disorder such as anorexia or bulimia

13. Subject has been diagnosed with chronic kidney disease that results in chronic anemia

14. Subject is on dialysis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Investigations, Inc.	Little Rock	Arkansas	United States	72205
2	AMCR Institute	Escondido	California	United States	92026
3	Valley Research	Fresno	California	United States	93720
4	Center of Excellence in Diabetes & Endocrinology	Sacramento	California	United States	98521
5	So Cal Diabetes	Torrance	California	United States	90505
6	Barbara Davis Center (1)	Aurora	Colorado	United States	80045
7	Barbara Davis Center (2)	Aurora	Colorado	United States	80045
8	East Coast Institute for Research	Jacksonville	Florida	United States	32204
9	Endocrine Associates of Florida, P.A.	Lake Mary	Florida	United States	32746
10	TLC Diabetes Healthcare Consultants & Education Inc.	Naples	Florida	United States	34109
11	Pediatric Endocrine Associates	Tampa	Florida	United States	33607
12	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
13	East Alabama Endocrinology PC	Columbus	Georgia	United States	31907
14	Endocrine Research Solutions	Roswell	Georgia	United States	30076
15	The University of Chicago	Chicago	Illinois	United States	60637
16	Isaiah Pittman IV, MD	Terre Haute	Indiana	United States	47802
17	Good Samaritan Hospital Physician Services	Vincennes	Indiana	United States	47591
18	Iowa Diabetes and Endocrinology Center	Des Moines	Iowa	United States	50314
19	Imperial Health	Lake Charles	Louisiana	United States	70601
20	Eastern Shore Diabetes and Endocrinology Center	Salisbury	Maryland	United States	21804
21	University of Michigan Diabetes Research Center	Ann Arbor	Michigan	United States	48105
22	Grunberger Diabetes Institute	Bloomfield Hills	Michigan	United States	48302
23	Spectrum Health System	Grand Rapids	Michigan	United States	49546
24	International Diabetes Center	Minneapolis	Minnesota	United States	55416
25	Mayo Clinic	Rochester	Minnesota	United States	55902
26	The Diabetes Center	Ocean Springs	Mississippi	United States	39564
27	The Children's Mercy Hospital	Kansas City	Missouri	United States	64111
28	Billings Clinic	Billings	Montana	United States	59107
29	Glacier View Research Institute-Endocrinology	Kalispell	Montana	United States	59901
30	Complete Endocrinology	Lincoln	Nebraska	United States	68506
31	Diabetes, Endocrinology, Metabolism Specialties	Teaneck	New Jersey	United States	07666-3445
32	Winthrop University Hospital	Mineola	New York	United States	11501
33	Rochester General Hospital	Rochester	New York	United States	14621
34	Joslin Diabetes Center	Syracuse	New York	United States	13210
35	University at Buffalo, The State University of New York	Williamsville	New York	United States	14221
36	Physicians East, PA	Greenville	North Carolina	United States	27834
37	Oregon Health & Science University	Portland	Oregon	United States	97239
38	AM Diabetes and Endocrinology Center	Bartlett	Tennessee	United States	38133
39	Endeavor Clinical Trials	San Antonio	Texas	United States	78229
40	Consano Clinical Research, LLC	San Antonio	Texas	United States	78258
41	Northeast Clinical Research of San Antonio, LLC	Schertz	Texas	United States	78154
42	Southwestern Vermont Health Care	Bennington	Vermont	United States	05201
43	Tri-Cities Diabetes and Endocrinology Center	Richland	Washington	United States	99352

Sponsors and Collaborators

• Medtronic Diabetes

Investigators

• Study Director: Scott Lee, MD, Medtronic Diabetes

Study Documents (Full-Text)

• Study Protocol - Oct 10, 2017
• Statistical Analysis Plan - Feb 15, 2018

More Information

Publications

None provided.

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT02003898
• Other Study ID Numbers: CEP266
• First Posted: Dec 6, 2013
• Last Update Posted: Mar 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Medtronic Diabetes: Diabetes; Insulin pump; Threshold Suspend
• Additional relevant MeSH terms: Insulin

Study Results

Participant Flow

Arm/Group Title	Medtronic MiniMed 530G Insulin Pump
Arm/Group Description	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump
Period Title: Overall Study
STARTED	372
COMPLETED	305
NOT COMPLETED	67

Baseline Characteristics

Arm/Group Title	Medtronic MiniMed 530G Insulin Pump
Arm/Group Description	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump
Overall Participants	372
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.5 (15.9)
Sex: Female, Male (Count of Participants)
Female	201 54%
Male	171 46%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 4%
Not Hispanic or Latino	351 94.4%
Unknown or Not Reported	6 1.6%
Region of Enrollment (participants) [Number]
United States	372 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in A1C From Baseline to 1 Year
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Medtronic MiniMed 530G Insulin Pump
Arm/Group Description	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump
Measure Participants	298
Mean (95% Confidence Interval) [percentage]	0.034

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medtronic MiniMed 530G Insulin Pump
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.034
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.098
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtronic MiniMed 530G Insulin Pump
Arm/Group Description	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump
Measure Participants	83
Mean (Standard Deviation) [percentage]	0.32 (0.53)

3. Secondary Outcome

Title	Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%
Description	Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtronic MiniMed 530G Insulin Pump
Arm/Group Description	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump
Measure Participants	187
Mean (Standard Deviation) [percentage]	-0.04 (0.67)

4. Secondary Outcome

Title	Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%
Description	Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c > 9%
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtronic MiniMed 530G Insulin Pump
Arm/Group Description	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump
Measure Participants	28
Mean (Standard Deviation) [percentage]	-0.39 (0.96)

Adverse Events

Time Frame	1 year
Arm/Group Title	Medtronic MiniMed 530G Insulin Pump
Arm/Group Description	All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump. Medtronic MiniMed 530G Insulin Pump
All Cause Mortality
	Medtronic MiniMed 530G Insulin Pump
	Affected / at Risk (%)	# Events
Total	3/372 (0.8%)
Serious Adverse Events
	Medtronic MiniMed 530G Insulin Pump
	Affected / at Risk (%)	# Events
Total	19/372 (5.1%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/372 (0.3%)	1
Cardiac disorders
Acute myocardial infarction	1/372 (0.3%)	1
Gastrointestinal disorders
Gastric ulcer	1/372 (0.3%)	1
Pancreatitis acute	1/372 (0.3%)	4
General disorders
Chest pain	1/372 (0.3%)	1
Death	1/372 (0.3%)	1
Non-cardiac chest pain	1/372 (0.3%)	1
Hepatobiliary disorders
Bile duct obstruction	1/372 (0.3%)	1
Infections and infestations
Cellulitis staphylococcal	1/372 (0.3%)	1
Upper respiratory tract infection	1/372 (0.3%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	5/372 (1.3%)	5
Hyperglycaemia	4/372 (1.1%)	4
Hypoglycaemia	1/372 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed hepatocellular cholangiocarcinoma	1/372 (0.3%)	1
Oropharyngeal cancer	1/372 (0.3%)	1
Plasma cell myeloma	1/372 (0.3%)	1
Nervous system disorders
Altered state of consciousness	1/372 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Medtronic MiniMed 530G Insulin Pump
	Affected / at Risk (%)	# Events
Total	37/372 (9.9%)
General disorders
Infusion site erythema	1/372 (0.3%)	1
Medical device site reaction	1/372 (0.3%)	1
Puncture site haemorrhage	9/372 (2.4%)	14
Infections and infestations
Abscess limb	1/372 (0.3%)	1
Cellulitis	1/372 (0.3%)	1
Dermatophytosis	1/372 (0.3%)	1
Infusion site infection	1/372 (0.3%)	1
Skin infection	2/372 (0.5%)	2
Injury, poisoning and procedural complications
Contusion	2/372 (0.5%)	3
Nerve injury	1/372 (0.3%)	1
Scar	1/372 (0.3%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/372 (0.3%)	1
Hyperglycaemia	10/372 (2.7%)	13
Hypoglycaemia	4/372 (1.1%)	4
Nervous system disorders
Convulsion	1/372 (0.3%)	1
Sciatica	1/372 (0.3%)	1
Renal and urinary disorders
Ketonuria	1/372 (0.3%)	1
Skin and subcutaneous tissue disorders
Ecchymosis	1/372 (0.3%)	1
Rash	1/372 (0.3%)	1
Skin irritation	2/372 (0.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.