Trial Outcomes & Findings for Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes (NCT NCT01483352)
NCT ID: NCT01483352
Last Updated: 2016-04-15
Results Overview
Suitability of the device was assessed by the investigator using a questionnaire that determined the following: 1) condition of the tissue around the port: tight connection between port and skin (mechanical stability, dislocation of port, signs of redness/swelling, infection, or pain), 2) peritoneal reactions (persistent dull pain due to catheter, signs of infection/allergic reaction) and ability to deliver insulin intraperitonally at every visit after implantation. Suitability score was determined using participant's responses to a questionnaire where 1 equals (=) no problem, 2=minor/negligible problems, 3=some/noticeable problems, 4=major/cumbersome and 5=severe/almost unbearable problems. Each question was scored and an average across the questions was determined as an overall score. The scores ranged from 1 (not at all suitable) to 5 (completely suitable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Week 12
Results posted on
2016-04-15
Participant Flow
Participant milestones
| Measure |
Accu-Chek DiaPort
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes
Baseline characteristics by cohort
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All participants who received the implant were included in the analysis.
Suitability of the device was assessed by the investigator using a questionnaire that determined the following: 1) condition of the tissue around the port: tight connection between port and skin (mechanical stability, dislocation of port, signs of redness/swelling, infection, or pain), 2) peritoneal reactions (persistent dull pain due to catheter, signs of infection/allergic reaction) and ability to deliver insulin intraperitonally at every visit after implantation. Suitability score was determined using participant's responses to a questionnaire where 1 equals (=) no problem, 2=minor/negligible problems, 3=some/noticeable problems, 4=major/cumbersome and 5=severe/almost unbearable problems. Each question was scored and an average across the questions was determined as an overall score. The scores ranged from 1 (not at all suitable) to 5 (completely suitable).
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Suitability of the Device - Overall Suitability Score
|
2.00 units on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the study; number (n)= number of participants analyzed for the given parameter at the specified timepoint
Mechanical stability of the device was determined by the stability of the ingrowth surrounding the port as determined by the physician. The ingrowth problems are categorized as follows: Category 1= complete stable Ingrowth, 2= Ingrowth working with negligible problems, 3= Ingrowth working with some problems, 4= Ingrowth working with major problems and 5= Ingrowth resulting in almost non-functional port. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 1, Week 2 (n=12)
|
33 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 2, Week 2 (n=12)
|
50 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 3, Week 2 (n=12)
|
17 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 4, Week 2 (n=12)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 5, Week 2 (n=12)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 1, Week 12 (n=12)
|
75 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 2, Week 12 (n=12)
|
25 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 3, Week 12 (n=12)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 4, Week 12 (n=12)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 5, Week 12 (n=12)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 1, Month 6 (n=11)
|
36 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 2, Month 6 (n=11)
|
55 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 3, Month 6 (n=11)
|
9 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 4, Month 6 (n=11)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 5, Month 6 (n=11)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 1, Month 9 (n=11)
|
55 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 2, Month 9 (n=11)
|
46 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 3, Month 9 (n=11)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 4, Month 9 (n=11)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 5, Month 9 (n=11)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 1, Month 12 (n=10)
|
70 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 2, Month 12 (n=10)
|
30 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 3, Month 12 (n=10)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 4, Month 12 (n=10)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 5, Month 12 (n=10)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 1, Month 15 (n=11)
|
64 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 2, Month 15 (n=11)
|
27 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 3, Month 15 (n=11)
|
9 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 4, Month 15 (n=11)
|
0 percentage of partcipants
|
|
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
Category 5, Month 15 (n=11)
|
0 percentage of partcipants
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Position of the port was determined by the physician and was categorized as follows: Category 1= No dislocation; 2= Minimal dislocation; 3= Clearly visible dislocation, with minimal impairment of function; 4= Dislocation impairs functions; 5= Dislocation results in disabling functions. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants With Dislocation of Port
Category 1, Week 2 (n=12)
|
100 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 2, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 3, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 4, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 5, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 1, Week 12 (n=12)
|
67 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 2, Week 12 (n=12)
|
25 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 3, Week 12 (n=12)
|
8 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 4, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 5, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 1, Month 6 (n=11)
|
73 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 2, Month 6 (n=11)
|
27 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 3, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 4, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 5, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 1, Month 9 (n=11)
|
82 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 2, Month 9 (n=11)
|
18 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 3, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 4, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 5, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 1, Month 12 (n=10)
|
80 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 2, Month 12 (n=10)
|
20 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 3, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 4, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 5, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 1, Month 15 (n=11)
|
82 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 2, Month 15 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 3, Month 15 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 4, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Dislocation of Port
Category 5, Month 15 (n=11)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Signs of Redness/Swelling was determined by the physician and was categorized as follows: Category 1= None; 2= Minor, negligible; 3= Some, noticeable; 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 1, Week 2 (n=12)
|
50 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 2, Week 2 (n=12)
|
33 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 3, Week 2 (n=12)
|
17 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 4, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 5, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 1, Week 12 (n=12)
|
67 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 2, Week 12 (n=12)
|
25 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 3, Week 12 (n=12)
|
8 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 4, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 5, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 1, Month 6 (n=11)
|
55 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 2, Month 6 (n=11)
|
36 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 3, Month 6 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 4, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 5, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 1, Month 9 (n=11)
|
64 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 2, Month 9 (n=11)
|
27 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 3, Month 9 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 4, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 5, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 1, Month 12 (n=10)
|
60 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 2, Month 12 (n=10)
|
40 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 3, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 4, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 5, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 1, Month 15 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 2, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 3, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 4, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
Category 5, Month 15 (n=11)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Signs of infection were determined by the physician and categorized as follows : Category 1= None; 2= Minor, negligible; 3= Some, noticeable 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 1, Week 2 (n=12)
|
75 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 2, Week 2 (n=12)
|
8 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 3, Week 2 (n=12)
|
17 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 4, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 5, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 1, Week 12 (n=12)
|
83 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 2, Week 12 (n=12)
|
17 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 3, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 4, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 5, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 1, Month 6 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 2, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 3, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 4, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 5, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 1, Month 9 (n=11)
|
91 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 2, Month 9 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 3, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 4, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 5, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 1, Month 12 (n=10)
|
90 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 2, Month 12 (n=10)
|
10 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 3, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 4, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 5, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 1, Month 15 (n=11)
|
64 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 2, Month 15 (n=11)
|
36 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 3, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 4, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection in the Tissue Around the Port
Category 5, Month 15 (n=11)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Signs of pain was determined from the participant questionnaire which was categorized as follows: category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5=Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 1, Week 2 (n=12)
|
83 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 2, Week 2 (n=12)
|
17 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 3, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 4, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 5, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 1, Week 12 (n=12)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 2, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 3, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 4, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 5, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 1, Month 6 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 2, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 3, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 4, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 5, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 1, Month 9 (n=11)
|
91 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 2, Month 9 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 3, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 4, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 5, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 1, Month 12 (n=10)
|
80 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 2, Month 12 (n=10)
|
20 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 3, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 4, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 5, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 1, Month 15 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 2, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 3, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 4, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Pain in the Tissue Around the Port
Category 5, Month 15 (n=11)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Pain due to catheter was determined by a participant questionnaire and categorized as follows: Category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5= Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 1, Week 2 (n=12)
|
83 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 2, Week 2 (n=12)
|
17 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 3, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 4, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 5, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 1, Week 12 (n=12)
|
100 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 2, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 3, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 4, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 5, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 1, Month 6 (n=11)
|
91 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 2, Month 6 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 3, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 4, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 5, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 1, Month 9 (n=11)
|
82 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 2, Month 9 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 3, Month 9 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 4, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 5, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 1, Month 12 (n=10)
|
70 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 2, Month 12 (n=10)
|
30 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 3, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 4, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 5 Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 1, Month 15 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 2, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 3, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 4, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Persistent Dull Pain Due to Catheter
Category 5, Month 15 (n=11)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Signs of infection/allergic reaction at the site of implant was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 1, Week 2 (n=12)
|
83 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 2, Week 2 (n=12)
|
17 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 3, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 4, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 5, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 1, Week 12 (n=12)
|
92 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 2, Week 12 (n=12)
|
8 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 3, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 4, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 5, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 1, Month 6 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 2, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 3, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 4, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 5, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 1, Month 9 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 2, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 3, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 4, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 5, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 1, Month 12 (n=10)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 2, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 3, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 4, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 5, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 1, Month 15 (n=11)
|
100 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 2, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 3, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 4, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
Category 5, Month 15 (n=11)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 and Months 6, 9, 12 and 15Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Problems in ability to deliver insulin intraperitoneally was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 1, Week 2 (n=12)
|
100 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 2, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 3, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 4, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 5, Week 2 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 1, Week 12 (n=12)
|
50 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 2, Week 12 (n=12)
|
42 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 3, Week 12 (n=12)
|
8 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 4, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 5, Week 12 (n=12)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 1, Month 6 (n=11)
|
64 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 2, Month 6 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 3, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 4, Month 6 (n=11)
|
27 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 5, Month 6 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 1, Month 9 (n=11)
|
91 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 2, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 3, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 4, Month 9 (n=11)
|
9 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 5, Month 9 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 1, Month 12 (n=10)
|
70 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 2, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 3, Month 12 (n=10)
|
10 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 4, Month 12 (n=10)
|
20 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 5, Month 12 (n=10)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 1, Month 15 (n=11)
|
55 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 2, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 3, Month 15 (n=11)
|
0 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 4, Month 15 (n=11)
|
45 percentage of participants
|
|
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
Category 5, Month 15 (n=11)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, Week 12 and Months 6, 9 and 12Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Total insulin dose (in international units per milliliter \[IU/mL\]) from pump was measured per day as mean per day measured over 7 days.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Insulin Doses Dispensed From Insulin Pump
Daily insulin dose - Screening (n=12)
|
49.3 IU/mL
Standard Deviation 53.2
|
|
Insulin Doses Dispensed From Insulin Pump
Daily insulin dose - Week 12 (n=12)
|
45.2 IU/mL
Standard Deviation 30.1
|
|
Insulin Doses Dispensed From Insulin Pump
Daily insulin dose - Month 6 (n=11)
|
43.8 IU/mL
Standard Deviation 32.7
|
|
Insulin Doses Dispensed From Insulin Pump
Daily insulin dose - Month 9 (n=11)
|
43.8 IU/mL
Standard Deviation 36.4
|
|
Insulin Doses Dispensed From Insulin Pump
Daily insulin dose - Month 12 (n=10)
|
40.8 IU/mL
Standard Deviation 34.5
|
|
Insulin Doses Dispensed From Insulin Pump
Daily basal insulin dose - Screening (n=12)
|
9.6 IU/mL
Standard Deviation 4.8
|
|
Insulin Doses Dispensed From Insulin Pump
Daily basal insulin dose - Week 12 (n=12)
|
11.1 IU/mL
Standard Deviation 5.1
|
|
Insulin Doses Dispensed From Insulin Pump
Daily basal insulin dose - Month 6 (n=11)
|
9.9 IU/mL
Standard Deviation 4.5
|
|
Insulin Doses Dispensed From Insulin Pump
Daily basal insulin dose - Month 9 (n=11)
|
10.1 IU/mL
Standard Deviation 4.5
|
|
Insulin Doses Dispensed From Insulin Pump
Daily basal insulin dose - Month 12 (n=10)
|
9.3 IU/mL
Standard Deviation 4.6
|
|
Insulin Doses Dispensed From Insulin Pump
Daily bolus insulin dose - Screening (n=12)
|
39.6 IU/mL
Standard Deviation 49.3
|
|
Insulin Doses Dispensed From Insulin Pump
Daily bolus insulin dose - Week 12 (n=12)
|
34.1 IU/mL
Standard Deviation 26.9
|
|
Insulin Doses Dispensed From Insulin Pump
Daily bolus insulin dose - Month 6 (n=11)
|
33.8 IU/mL
Standard Deviation 29.6
|
|
Insulin Doses Dispensed From Insulin Pump
Daily bolus insulin dose - Month 9 (n=11)
|
33.7 IU/mL
Standard Deviation 33.2
|
|
Insulin Doses Dispensed From Insulin Pump
Daily bolus insulin dose - Month 12 (n=10)
|
31.6 IU/mL
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: Screening, Week 12 and Months 6, 9 and 12Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. HbA1c levels are a measure of glycemic control.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Hemoglobin A1c Levels
Screening (n=12)
|
8.99 percent of glycated hemoglobin
Standard Deviation 1.13
|
|
Hemoglobin A1c Levels
Week 12 (n=12)
|
7.99 percent of glycated hemoglobin
Standard Deviation 0.97
|
|
Hemoglobin A1c Levels
Month 6 (n=11)
|
7.57 percent of glycated hemoglobin
Standard Deviation 0.64
|
|
Hemoglobin A1c Levels
Month 9 (n=11)
|
7.73 percent of glycated hemoglobin
Standard Deviation 1.01
|
|
Hemoglobin A1c Levels
Month 12 (n=10)
|
8.38 percent of glycated hemoglobin
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Screening, Week 12 and Months 6, 9 and 12Population: All participants were included in analysis; n= number of participants analyzed for the given parameter at the specified time point
Participants monitored glucose levels on a daily basis and recorded for evaluation. Glucose levels are measured as milligrams per deciliter (mg/dL)
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Self Monitored Blood Glucose Levels
Screening (n=12)
|
185.1 mg/dL
Standard Deviation 33.0
|
|
Self Monitored Blood Glucose Levels
Week 12 (n=12)
|
176.6 mg/dL
Standard Deviation 31.1
|
|
Self Monitored Blood Glucose Levels
Month 6 (n=11)
|
164.1 mg/dL
Standard Deviation 30.6
|
|
Self Monitored Blood Glucose Levels
Month 9 (n=11)
|
174.7 mg/dL
Standard Deviation 44.2
|
|
Self Monitored Blood Glucose Levels
Month 12 (n=10)
|
184.6 mg/dL
Standard Deviation 36.6
|
SECONDARY outcome
Timeframe: Screening, Week 12 and 6 MonthsPopulation: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
CGM measurements were performed using a diurnal CGM sensor and group means were calculated over 10 minute periods of the CGM measurements.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Continuous Glucose Measurement (CGM) - Glucose Levels
Week 12 (n=12)
|
174.3 mg/dL
Standard Deviation 20.3
|
|
Continuous Glucose Measurement (CGM) - Glucose Levels
Month 6 (n=11)
|
173.4 mg/dL
Standard Deviation 24.9
|
|
Continuous Glucose Measurement (CGM) - Glucose Levels
Screening (n=12)
|
200.7 mg/dL
Standard Deviation 39.6
|
SECONDARY outcome
Timeframe: Screening, Week 12 and Months 6, 9 and 12Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
Both self monitored (SMBG) and continuous (CGM) glucose measurements were used to determine the coefficient of variation in blood glucose. CGM data are only evaluated for a 1 week time period and are no direct comparison to the SMBG that reflect the full time frame between visits.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
SMBG - Screening (n=12)
|
45.1 percent of mean glucose value
Standard Deviation 9.8
|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
SMBG - Week 12 (n=12)
|
38.4 percent of mean glucose value
Standard Deviation 5.9
|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
SMBG - Month 6 (n=11)
|
41.7 percent of mean glucose value
Standard Deviation 9.4
|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
SMBG - Month 9 (n=11)
|
38.5 percent of mean glucose value
Standard Deviation 7.2
|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
SMBG - Month 12 (n=10)
|
38.8 percent of mean glucose value
Standard Deviation 7.1
|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
CGM - Screening (n=12)
|
40.3 percent of mean glucose value
Standard Deviation 8.5
|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
CGM - Week 12 (n=12)
|
37.8 percent of mean glucose value
Standard Deviation 9.0
|
|
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
CGM - Month 6 (n=11)
|
38.2 percent of mean glucose value
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Screening, Week 12 and 6 MonthsPopulation: All participants were included in the study; n= number of participants analyzed for the given parameter at the specified timepoint
Target glucose values were 70-180 mg/dL. Participants with glucose levels below 70 mg/dL were considered to be under target and those above 180 mg/dL were considered over target. The mean of Glucose-Measurements at the visit date was calculated as follows: a variable was created for each category ("within target \[70-180 mg\]", "below target" and "above target") that tells if the value lies within this category. Then the percentage per participant and visit was calculated. The mean represents the mean of these percentages per participant at the visit.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Percentage of Participants Achieving Target Glucose Levels
Within target range - Screening (n=12)
|
44.6 percentage of participants
Standard Deviation 14.4
|
|
Percentage of Participants Achieving Target Glucose Levels
Within target range - Week 12 (n=12)
|
56.5 percentage of participants
Standard Deviation 12.0
|
|
Percentage of Participants Achieving Target Glucose Levels
Within target range - Month 6 (n=11)
|
58.3 percentage of participants
Standard Deviation 13.1
|
|
Percentage of Participants Achieving Target Glucose Levels
Above target range - Screening (n=12)
|
52.6 percentage of participants
Standard Deviation 15.5
|
|
Percentage of Participants Achieving Target Glucose Levels
Above target range - Week 12 (n=12)
|
39.9 percentage of participants
Standard Deviation 11.7
|
|
Percentage of Participants Achieving Target Glucose Levels
Above target range - Month 6 (n=11)
|
37.8 percentage of participants
Standard Deviation 13.5
|
|
Percentage of Participants Achieving Target Glucose Levels
Below target range - Screening (n=12)
|
2.9 percentage of participants
Standard Deviation 2.8
|
|
Percentage of Participants Achieving Target Glucose Levels
Below target range - Week 12 (n=12)
|
3.6 percentage of participants
Standard Deviation 3.7
|
|
Percentage of Participants Achieving Target Glucose Levels
Below target range - Month 6 (n=11)
|
3.8 percentage of participants
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Week 12Population: All participants were included in the analysis.
The participant questionnaire consisted of two parts including description of routine operations, followed by 23 questions used to determine the following: percentage of participants needing consultation of instructions for use of fixation disc or infusion set; percentage of participants with pain after implantation, percentage of participants with moderate pain during 4 to 6 days after implantation, moderate pain for 7 days or more; percentage of participants with temporal disconnection from infusion set; percentage of participants with use of handling aid for temporal storage; percentage of participants with a reason for temporal disconnection of infusion set from port either sex, shower, or sport; percentage of participants changing fixation disc ≥3 days or infusion set ≥4 days and the cartridge, and percentage of participants cleaning the skin around the port daily, every second day, or every third to fifth day, either with saline during healing or with alcohol after healing.
Outcome measures
| Measure |
Accu-Chek DiaPort
n=12 Participants
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Needing Instruction for Fixation disc
|
92 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Needing Instruction for Infusion set
|
92 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
With Pain after implantation
|
75 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Moderate pain after implantation during 4 - 6 days
|
17 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Moderate pain after implantation 7 days or more
|
17 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Disconnection of infusion set from port-daily
|
33 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Disconnection of infusion set from port-never
|
33 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Stopped pump during temporal disconnection
|
17 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Used handling aid for temporal storage
|
83 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Reason for temporal disconnection-sex
|
33 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Reason for temporal disconnection-shower
|
83 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Reason for temporal disconnection-sport
|
17 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Changed fixation disc after ≥3 days
|
75 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Changed infusion set after ≥4 days
|
83 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Changed cartride and infusion set simultaneously
|
92 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Changed fixation disc and cartridge simultaneously
|
55 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Cleaned skin around port-daily
|
50 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Cleaned skin around port-every second day
|
17 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Cleaned skin around port-3rd to 5th day
|
17 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Cleaned skin around port-with saline
|
58 percentage of participants
|
|
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
Cleaned skin around port-with alcohol
|
50 percentage of participants
|
Adverse Events
Accu-Chek DiaPort
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Accu-Chek DiaPort
n=12 participants at risk
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Injury, poisoning and procedural complications
Diaport replacement
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Injury, poisoning and procedural complications
Complete catheter occlusion
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Injury, poisoning and procedural complications
Catheter replacement
|
16.7%
2/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Injury, poisoning and procedural complications
Over growth of abdominal catheter
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Endocrine disorders
Symptomatic hypoglycemia
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Endocrine disorders
Hyperglycemia
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Endocrine disorders
Diabetic ketoacidosis
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Endocrine disorders
Instable blood sugar
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Cardiac disorders
Coronary bypass surgery
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
Other adverse events
| Measure |
Accu-Chek DiaPort
n=12 participants at risk
Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
|
|---|---|
|
Cardiac disorders
Chronic ischaemic heart disease
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic lower respiratory disease
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Surgical and medical procedures
Complications of other internal prosthetic devices, implants and grafts
|
58.3%
7/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Gastrointestinal disorders
Disease of pancreas, unspecified
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Gastrointestinal disorders
Diseases of oesophagus, stomach and duodenum
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Metabolism and nutrition disorders
Disorders of lipoprotein metabolism and other lipidaemias
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Musculoskeletal and connective tissue disorders
Dorsalgia, unspecified
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Vascular disorders
Essential (primary) hypertension
|
16.7%
2/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Gastrointestinal disorders
Functional diarrhea
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
2/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Vascular disorders
Hypertensive disease
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Metabolism and nutrition disorders
Insulin-dependent diabetes mellitus
|
58.3%
7/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Metabolism and nutrition disorders
Insulin-dependent diabetes mellitus with renal complications
|
16.7%
2/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Psychiatric disorders
Mental and behavioural disorders
|
16.7%
2/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Metabolism and nutrition disorders
Metabolic disorders
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Surgical and medical procedures
Other and unspecified medical devices associated with adverse incidents
|
83.3%
10/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Gastrointestinal disorders
Other diseases of intestines
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Other diseases of upper respiratory tract
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Renal and urinary disorders
Other diseases of urinary system
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Musculoskeletal and connective tissue disorders
Other soft tissue disorders, not elsewhere classified
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Gastrointestinal disorders
Pain localized to upper abdomen
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Surgical and medical procedures
Presents of coronary angioplasty implant and graft
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Skin and subcutaneous tissue disorders
Scar conditions and fibrosis of skin
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Injury, poisoning and procedural complications
Superficial injury of unspecified body region
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Gastrointestinal disorders
Symptoms and signs involving the digestive system and abdomen
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
|
Infections and infestations
Urinary tract infection, site not specified
|
8.3%
1/12 • Adverse events were reported from the date of implantation until the end of study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER