Trial Outcomes & Findings for Obtain a Good Blood Glucose Control With the Paradigm Real Time System (NCT NCT00441129)
NCT ID: NCT00441129
Last Updated: 2018-12-05
Results Overview
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Conventional Insulin Pump Therapy
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
55
|
|
Overall Study
COMPLETED
|
54
|
41
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
Reasons for withdrawal
| Measure |
Conventional Insulin Pump Therapy
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
14
|
Baseline Characteristics
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
Baseline characteristics by cohort
| Measure |
Conventional Insulin Pump Therapy
n=60 Participants
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
n=55 Participants
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
28.1 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
60 participants
n=5 Participants
|
55 participants
n=7 Participants
|
115 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsDifference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Outcome measures
| Measure |
Conventional Insulin Pump Therapy
n=60 Participants
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
n=55 Participants
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
|---|---|---|
|
Difference in HbA1C From Baseline and 6 Months
|
-0.57 percentage of HbA1C
Standard Deviation 0.94
|
-0.81 percentage of HbA1C
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsDifference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline
Outcome measures
| Measure |
Conventional Insulin Pump Therapy
n=60 Participants
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
n=55 Participants
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
|---|---|---|
|
Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
|
-10.8 mg/dL
Standard Deviation 39.6
|
-30.6 mg/dL
Standard Deviation 54
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsDifference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline
Outcome measures
| Measure |
Conventional Insulin Pump Therapy
n=60 Participants
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
n=55 Participants
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
|---|---|---|
|
Change From Baseline in Total Daily Dose (TDD)
|
6.8 units/day
Standard Deviation 17.3
|
1.5 units/day
Standard Deviation 9.1
|
Adverse Events
Conventional Insulin Pump Therapy
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Minimed Paradigm Real Time Sytem
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional Insulin Pump Therapy
n=60 participants at risk
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
n=55 participants at risk
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
|---|---|---|
|
Metabolism and nutrition disorders
Ketoacidosis
|
5.0%
3/60 • Number of events 3 • 6 months
|
3.6%
2/55 • Number of events 2 • 6 months
|
|
Nervous system disorders
Hypoglycemic Coma
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Foot Surgery
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Nervous system disorders
Optic Neuritis
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Metabolism and nutrition disorders
Gastroenteritis
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
Other adverse events
| Measure |
Conventional Insulin Pump Therapy
n=60 participants at risk
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump
|
Minimed Paradigm Real Time Sytem
n=55 participants at risk
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem
|
|---|---|---|
|
Psychiatric disorders
Depression
|
5.0%
3/60 • Number of events 3 • 6 months
|
0.00%
0/55 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
4/60 • Number of events 4 • 6 months
|
0.00%
0/55 • 6 months
|
|
General disorders
Application site pain
|
5.0%
3/60 • Number of events 3 • 6 months
|
0.00%
0/55 • 6 months
|
|
General disorders
Application site bleeding
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Infections and infestations
Gastro-enteritis
|
1.7%
1/60 • Number of events 1 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Metabolism and nutrition disorders
Acidoketosis
|
3.3%
2/60 • Number of events 2 • 6 months
|
3.6%
2/55 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cutaneous irritation
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Vascular disorders
Hemorrhage
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Metabolism and nutrition disorders
Non-controlled diabetes mellitus
|
5.0%
3/60 • Number of events 3 • 6 months
|
0.00%
0/55 • 6 months
|
|
General disorders
Peripheral edema
|
5.0%
3/60 • Number of events 3 • 6 months
|
0.00%
0/55 • 6 months
|
|
Nervous system disorders
Diabetic neuropathy
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Eye disorders
Visual acuity reduced
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/60 • Number of events 1 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Extremity injury
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Eye disorders
Blindness unilateral
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Infections and infestations
Influenza
|
3.3%
2/60 • Number of events 2 • 6 months
|
0.00%
0/55 • 6 months
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
3.3%
2/60 • Number of events 2 • 6 months
|
0.00%
0/55 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/60 • 6 months
|
0.00%
0/55 • 6 months
|
|
Infections and infestations
Bronchitis
|
5.0%
3/60 • Number of events 3 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Nervous system disorders
Paresthesia
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
General disorders
Implantation site pruritis
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Infections and infestations
Varicella
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
General disorders
Application site exfoliation
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
General disorders
Injection site inflammation
|
1.7%
1/60 • Number of events 1 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.7%
1/60 • Number of events 1 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis
|
1.7%
1/60 • Number of events 1 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
General disorders
Perfusion site hematoma
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Nervous system disorders
Hypoglycemic coma
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
Infections and infestations
Abcess injection site
|
1.7%
1/60 • Number of events 1 • 6 months
|
0.00%
0/55 • 6 months
|
|
General disorders
Application site erythema
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Cleft lip repair
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cutaneous reaction
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Foot surgery
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
General disorders
Injection site eczema
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
|
Infections and infestations
Abdominal abcess
|
0.00%
0/60 • 6 months
|
1.8%
1/55 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60