Trial Outcomes & Findings for Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy (NCT NCT00417989)

NCT ID: NCT00417989

Last Updated: 2018-05-23

Results Overview

Change is defined as A1c at Week 52 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: 485 participants
• Primary outcome timeframe: Baseline and 52 weeks
• Results posted on: 2018-05-23

Participant Flow

Participant milestones

Measure	722 Sensor Augmented Pump 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Study STARTED	244	241
Overall Study COMPLETED	224	219
Overall Study NOT COMPLETED	20	22

Reasons for withdrawal

Measure	722 Sensor Augmented Pump 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Study Withdrawal by Subject	13	13
Overall Study Lost to Follow-up	1	6
Overall Study Protocol Violation	1	0
Overall Study Death	0	1
Overall Study Physician Decision	5	2

Baseline Characteristics

Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy

Baseline characteristics by cohort

Measure	722 Sensor Augmented Pump n=244 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year	Total n=485 Participants Total of all reporting groups
Age, Continuous	32.2 years STANDARD_DEVIATION 17.47 • n=5 Participants	31.50 years STANDARD_DEVIATION 16.50 • n=7 Participants	31.90 years STANDARD_DEVIATION 16.98 • n=5 Participants
Age, Customized <=18 years	77 participants n=5 Participants	72 participants n=7 Participants	149 participants n=5 Participants
Age, Customized Between 19 and 70 years	167 participants n=5 Participants	169 participants n=7 Participants	336 participants n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	107 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	134 Participants n=7 Participants	274 Participants n=5 Participants
Region of Enrollment United States	216 participants n=5 Participants	211 participants n=7 Participants	427 participants n=5 Participants
Region of Enrollment Canada	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 52 weeks

Change is defined as A1c at Week 52 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	722 Sensor Augmented Pump n=244 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Change in A1c From Baseline to 52 Weeks	-0.8 Percent glycated hemoglobin Standard Deviation 0.84	-0.2 Percent glycated hemoglobin Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.

Outcome measures

Measure	722 Sensor Augmented Pump n=244 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;	32 number of events	27 number of events

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.

Outcome measures

Measure	722 Sensor Augmented Pump n=244 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52	21 participants	17 participants

SECONDARY outcome

Timeframe: Baseline and 52 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 52.

Outcome measures

Measure	722 Sensor Augmented Pump n=244 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;	0.0 mmol/dl*min Standard Deviation 0.66	0.0 mmol/dl*min Standard Deviation 0.60

SECONDARY outcome

Timeframe: Baseline and 52 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 52.

Outcome measures

Measure	722 Sensor Augmented Pump n=244 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52	-11.9 mmol/dl*min Standard Deviation 19.31	-1.1 mmol/dl*min Standard Deviation 22.07

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Adult population (18 and older) only

Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.

Outcome measures

Measure	722 Sensor Augmented Pump n=152 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=151 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score	-9.0 participants Standard Deviation 16.04	-2.4 participants Standard Deviation 15.88

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Health Economic Outcome was a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors. This analysis was restricted to only adult subjects (Age 19 to 70), therefore the number of participant analyzed is different. The goal was to estimate the long term cost effectiveness of Sensor Augmented Pump therapy from the perspective of the US health care system. The unit of measurement was cost in $ per year for sensor augmented pump group and MDI group. No formal statistical analysis was planned or performed

Outcome measures

Measure	722 Sensor Augmented Pump n=166 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=163 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Health Economic Outcome	10,760 $	5,072 $

SECONDARY outcome

Timeframe: Baseline and 52 Weeks

Population: Adult population (18 and older) only

Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.

Outcome measures

Measure	722 Sensor Augmented Pump n=153 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=151 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Quality of Life - Short Form-36 (SF-36v2™), General Health	2.7 Participants Standard Deviation 8.07	-0.3 Participants Standard Deviation 7.13

SECONDARY outcome

Timeframe: Baseline and 52 Weeks

Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.

Outcome measures

Measure	722 Sensor Augmented Pump n=220 Participants 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=214 Participants MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy	18.4 participants Standard Deviation 25.61	-0.2 participants Standard Deviation 21.77

Adverse Events

722 Sensor Augmented Pump

Serious events: 32 serious events

Other events: 96 other events

Deaths: 0 deaths

Multiple Daily Injection (MDI)

Serious events: 30 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	722 Sensor Augmented Pump n=244 participants at risk 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 participants at risk MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Eye disorders Retinal Haemorrhage	0.41% 1/244 • Number of events 1	0.00% 0/241
Cardiac disorders Coronary Artery Disease	1.6% 4/244 • Number of events 4	0.41% 1/241 • Number of events 1
Metabolism and nutrition disorders Hypoglycemia	0.41% 1/244 • Number of events 1	0.00% 0/241
Metabolism and nutrition disorders Hypoglycemia (Severe Hypoglycemia)	3.3% 8/244 • Number of events 10	3.3% 8/241 • Number of events 12
Cardiac disorders Cardiac Arrest	0.00% 0/244	0.41% 1/241 • Number of events 1
Infections and infestations Pneumonia	0.41% 1/244 • Number of events 1	0.41% 1/241 • Number of events 1
Metabolism and nutrition disorders Diabetic Ketoacidosis (Ketoacidosis)	1.2% 3/244 • Number of events 3	0.83% 2/241 • Number of events 2
Injury, poisoning and procedural complications Fibula Fracture (Fracture of Left Lower Leg, Fibula at Ankle)	0.00% 0/244	0.41% 1/241 • Number of events 1
Infections and infestations Gastroenteritis (Acute Gastroenteritis)	0.82% 2/244 • Number of events 2	0.83% 2/241 • Number of events 2
Infections and infestations Urinary Tract Infection	0.41% 1/244 • Number of events 2	0.00% 0/241
General disorders Non-Cardiac (Atypical) Chest Pain	0.41% 1/244 • Number of events 1	0.00% 0/241
Injury, poisoning and procedural complications Skin Laceration (Traumatic Laceration to Dorsum of the Right Foot with extensor Hallucis Longus Tear	0.00% 0/244	0.41% 1/241 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer (Left Breast Cancer: Invasive Ductal Adenocarcinoma)	0.00% 0/244	0.41% 1/241 • Number of events 1
Injury, poisoning and procedural complications Urethral Injury (Urethral Tear)	0.00% 0/244	0.41% 1/241 • Number of events 1
Infections and infestations Cellulitis (Cellulitis of Left Lower Leg)	0.82% 2/244 • Number of events 2	0.41% 1/241 • Number of events 1
Gastrointestinal disorders Acute Pancreatitis	0.41% 1/244 • Number of events 1	0.00% 0/241
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.00% 0/244	0.41% 1/241 • Number of events 1
Injury, poisoning and procedural complications Limb Crushing Injury (Crush Injury to Right Lateral Thigh)	0.00% 0/244	0.41% 1/241 • Number of events 1
Nervous system disorders Syncope Vasovagal (Syncope Vasovagal Response)	0.41% 1/244 • Number of events 1	0.00% 0/241
Renal and urinary disorders Nephrolithiasis (Kidney Stones)	0.00% 0/244	0.41% 1/241 • Number of events 1
Metabolism and nutrition disorders Dehydration	0.41% 1/244 • Number of events 2	0.00% 0/241
Infections and infestations Gastroenteritis	0.82% 2/244 • Number of events 2	0.83% 2/241 • Number of events 2
Cardiac disorders Supraventricular Tachycardia	0.41% 1/244 • Number of events 1	0.00% 0/241
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/244	0.41% 1/241 • Number of events 1

Other adverse events

Measure	722 Sensor Augmented Pump n=244 participants at risk 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Multiple Daily Injection (MDI) n=241 participants at risk MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Metabolism and nutrition disorders Hypoglycemia	13.1% 32/244 • Number of events 88	11.6% 28/241 • Number of events 56
Infections and infestations Infusion/application site infection/abscess	4.9% 12/244 • Number of events 13	0.41% 1/241 • Number of events 1
General disorders Application site bleeding/bruising/irritation/pain	8.2% 20/244 • Number of events 20	1.7% 4/241 • Number of events 4
Metabolism and nutrition disorders Diabetic ketoacidosis	14.8% 36/244 • Number of events 51	7.1% 17/241 • Number of events 22
Metabolism and nutrition disorders Hyperglycemia	15.2% 37/244 • Number of events 46	2.9% 7/241 • Number of events 9

Additional Information

Scott Lee, M.D.

Medtronic

Phone: 8185764204

Email: scott.w.lee@medtronic.com

Results disclosure agreements

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

Restriction type: GT60