Diabetes Mellitus, Type 1
Conditions
Brief summary
The Accu-Chek DiaPort system enables continuous intraperitoneal insulin infusion (CIPII): that is, infusion of insulin into the peritoneal cavity using an Accu-Chek insulin pump and an infusion set. The Accu-Chek DiaPort consists of a metal body with a catheter that is placed in the abdomen. The opening of the port is raised above the surface of the skin about 5 millimeters, while a flower-shaped plate is placed under the skin, providing stability for the port. The port has been designed for those diabetics who cannot benefit fully from subcutaneous insulin infusion. The primary objective of the study is to assess the suitability of Accu-Chek DiaPort to perform continuous intraperitoneal insulin delivery. The data collection focuses on the condition of tissue around the port after the implantation, possible peritoneal reactions to the port system, and the peritoneal delivery of insulin. Secondary objectives are the assessments of therapeutic performance and successful implementation of design requirements. In total 12 Patients will participate in this open, mono-centre, single-arm, interventional clinical trial. The study lasts 9 months (without run in period of 3 to 1 week) separated in two parts. Phase I last 12 weeks. Phase II last 6 month until the end of the study. During the study, seven visits are planned. The screening visit can take place up to 3 weeks before study start. At the implantation visit which can last up to 5 days the port will be implanted. After the implantation insulin therapy will be adjusted for CIPII and the patients will be trained for handling and daily care of the Accu-Chek DiaPort system. To check the functionality of the system, the first control visit will take place 2 weeks and the second control visit 6 weeks after the implantation. At the week 12 visit, the most important parameters will be collected for the phase I report. The following visits take place 6 and 9 months after the implantation.
Interventions
DEVICEAccu-Chek DiaPort
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>= 18 years of age at the time of the screening visit * Type 1 diabetes mellitus * On CSII therapy for at least 6 months prior to the screening visit * Has been unsuccessfully treated with standard subcutaneous insulin therapy including CSII therapy, as defined by frequent (defined as handicapping in daily life) or severe (needing help from a third party) hypoglycemia and/or HbA1c above 8.5%, and/or other medical indication for CIPII therapy * Presence of at least one of the following indications for CIPII therapy: - Frequent (defined as handicapping daily life) hypoglycemia during CSII therapy - Severe hypoglycemia (needing help from a third party) during CSII therapy - HbA1c above 8.5% during CSII therapy - Hypoglycemia unawareness during CSII therapy - Real subcutaneous insulin resistance - Insulin-induced lipoatrophy - Insulin-associated lipohypertrophy not controlled by site rotation - Other skin disorders interfering with the subcutaneous route of administration - Marked fluctuations of glucose levels and insulin requirements during CSII therapy- History of allergies to materials required for subcutaneous insulin therapy * Performs usually self-management of blood glucose at least 4 times per day * Willing to adhere to the study visit schedule and motivated to undergo the therapy
Exclusion criteria
* Presence of marked peritoneal adhesions or scarring after abdominal surgery * Disorders of the gastrointestinal tract, respectively the digestive system potentially interfering with the intraperitoneal route of administration (e.g. presence of marked peritoneal adhesions, or colonic disease) * Known high levels of anti-insulin antibodies * History of allergy to materials used for the Accu-Chek DiaPort (titanium, polyethylene) * Severely impaired immune response * Uses systemic oral or inhaled steroids for \> 14 days within the last 3 months * Pregnant or lactating women, or women currently planning a pregnancy * Previous history of severe chronic liver disease defined as signs of portal hypertension and/or Quick's value below 50% in spite of vitamin K administration * Subject is treated for malignancy (chemotherapy, radiation or other treatment) (self-reported) * Positive for HIV infection * Is under CAPD treatment * Suffers from severe eating disorders like bulimia or anorexia * Alcohol or drug abuse * Serious psychological disorders like schizophrenia, depression, Münchhausen's syndrome etc. * Presence of known or suspected infections, bacteremia, septicemia or peritonitis * Participation in a clinical trial (medicinal, medical device) within the last 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Percentage of Participants With Dislocation of Port | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Percentage of Participants With Signs of Infection in the Tissue Around the Port | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Percentage of Participants With Signs of Pain in the Tissue Around the Port | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Percentage of Participants With Persistent Dull Pain Due to Catheter | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Weeks 2 and 12 and Months 6, 9, 12 and 15 | 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. |
| Suitability of the Device - Overall Suitability Score | Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c Levels | Screening, Week 12 and Months 6, 9 and 12 | 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. |
| Self Monitored Blood Glucose Levels | Screening, Week 12 and Months 6, 9 and 12 | Participants monitored glucose levels on a daily basis and recorded for evaluation. Glucose levels are measured as milligrams per deciliter (mg/dL) |
| Continuous Glucose Measurement (CGM) - Glucose Levels | Screening, Week 12 and 6 Months | CGM measurements were performed using a diurnal CGM sensor and group means were calculated over 10 minute periods of the CGM measurements. |
| Glycemic Variability: Percent Coefficient of Variation in Blood Glucose | Screening, Week 12 and Months 6, 9 and 12 | 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. |
| Percentage of Participants Achieving Target Glucose Levels | Screening, Week 12 and 6 Months | 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. |
| Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Week 12 | 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. |
| Insulin Doses Dispensed From Insulin Pump | Screening, Week 12 and Months 6, 9 and 12 | Total insulin dose (in international units per milliliter \[IU/mL\]) from pump was measured per day as mean per day measured over 7 days. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Accu-Chek DiaPort |
|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 8 / 12 |
Outcome results
Primary
Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 1, Week 2 (n=12) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 2, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 3, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 4, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 5, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 1, Week 12 (n=12) | 50 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 2, Week 12 (n=12) | 42 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 3, Week 12 (n=12) | 8 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 4, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 5, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 1, Month 6 (n=11) | 64 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 2, Month 6 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 3, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 4, Month 6 (n=11) | 27 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 5, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 1, Month 9 (n=11) | 91 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 2, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 3, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 4, Month 9 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 5, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 1, Month 12 (n=10) | 70 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 2, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 3, Month 12 (n=10) | 10 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 4, Month 12 (n=10) | 20 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 5, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 1, Month 15 (n=11) | 55 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 2, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 3, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 4, Month 15 (n=11) | 45 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally | Category 5, Month 15 (n=11) | 0 percentage of participants |
Primary
Percentage of Participants With Dislocation of Port
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 1, Week 2 (n=12) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 2, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 3, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 4, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 5, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 1, Week 12 (n=12) | 67 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 2, Week 12 (n=12) | 25 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 3, Week 12 (n=12) | 8 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 4, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 5, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 1, Month 6 (n=11) | 73 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 2, Month 6 (n=11) | 27 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 3, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 4, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 5, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 1, Month 9 (n=11) | 82 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 2, Month 9 (n=11) | 18 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 3, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 4, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 5, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 1, Month 12 (n=10) | 80 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 2, Month 12 (n=10) | 20 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 3, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 4, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 5, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 1, Month 15 (n=11) | 82 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 2, Month 15 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 3, Month 15 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 4, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Dislocation of Port | Category 5, Month 15 (n=11) | 0 percentage of participants |
Primary
Percentage of Participants With Persistent Dull Pain Due to Catheter
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 1, Week 2 (n=12) | 83 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 2, Week 2 (n=12) | 17 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 3, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 4, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 5, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 1, Week 12 (n=12) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 2, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 3, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 4, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 5, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 1, Month 6 (n=11) | 91 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 2, Month 6 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 3, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 4, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 5, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 1, Month 9 (n=11) | 82 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 2, Month 9 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 3, Month 9 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 4, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 5, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 1, Month 12 (n=10) | 70 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 2, Month 12 (n=10) | 30 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 3, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 4, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 5 Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 1, Month 15 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 2, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 3, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 4, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Persistent Dull Pain Due to Catheter | Category 5, Month 15 (n=11) | 0 percentage of participants |
Primary
Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the study; number (n)= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 1, Week 2 (n=12) | 33 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 2, Week 2 (n=12) | 50 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 3, Week 2 (n=12) | 17 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 4, Week 2 (n=12) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 5, Week 2 (n=12) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 1, Week 12 (n=12) | 75 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 2, Week 12 (n=12) | 25 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 3, Week 12 (n=12) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 4, Week 12 (n=12) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 5, Week 12 (n=12) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 1, Month 6 (n=11) | 36 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 2, Month 6 (n=11) | 55 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 3, Month 6 (n=11) | 9 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 4, Month 6 (n=11) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 5, Month 6 (n=11) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 1, Month 9 (n=11) | 55 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 2, Month 9 (n=11) | 46 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 3, Month 9 (n=11) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 4, Month 9 (n=11) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 5, Month 9 (n=11) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 1, Month 12 (n=10) | 70 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 2, Month 12 (n=10) | 30 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 3, Month 12 (n=10) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 4, Month 12 (n=10) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 5, Month 12 (n=10) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 1, Month 15 (n=11) | 64 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 2, Month 15 (n=11) | 27 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 3, Month 15 (n=11) | 9 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 4, Month 15 (n=11) | 0 percentage of partcipants |
| Accu-Chek DiaPort | Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin | Category 5, Month 15 (n=11) | 0 percentage of partcipants |
Primary
Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 3, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 2, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 1, Week 2 (n=12) | 83 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 2, Week 2 (n=12) | 17 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 4, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 5, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 1, Week 12 (n=12) | 92 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 2, Week 12 (n=12) | 8 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 3, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 4, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 5, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 1, Month 6 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 2, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 3, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 4, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 5, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 1, Month 9 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 3, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 4, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 5, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 1, Month 12 (n=10) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 2, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 3, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 4, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 5, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 1, Month 15 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 2, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 3, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant | Category 4, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | 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
Percentage of Participants With Signs of Infection in the Tissue Around the Port
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 3, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 1, Month 6 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 2, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 1, Week 2 (n=12) | 75 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 2, Week 2 (n=12) | 8 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 3, Week 2 (n=12) | 17 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 4, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 5, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 1, Week 12 (n=12) | 83 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 2, Week 12 (n=12) | 17 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 3, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 4, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 5, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 3, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 4, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 5, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 1, Month 9 (n=11) | 91 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 2, Month 9 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 4, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 5, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 1, Month 12 (n=10) | 90 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 2, Month 12 (n=10) | 10 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 3, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 4, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 5, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 1, Month 15 (n=11) | 64 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 2, Month 15 (n=11) | 36 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 3, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 4, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Infection in the Tissue Around the Port | Category 5, Month 15 (n=11) | 0 percentage of participants |
Primary
Percentage of Participants With Signs of Pain in the Tissue Around the Port
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 1, Week 2 (n=12) | 83 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 2, Week 2 (n=12) | 17 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 3, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 4, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 5, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 1, Week 12 (n=12) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 2, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 3, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 4, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 5, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 1, Month 6 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 2, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 3, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 4, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 5, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 1, Month 9 (n=11) | 91 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 2, Month 9 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 3, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 4, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 5, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 1, Month 12 (n=10) | 80 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 2, Month 12 (n=10) | 20 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 3, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 4, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 5, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 1, Month 15 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 2, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 3, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 4, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Pain in the Tissue Around the Port | Category 5, Month 15 (n=11) | 0 percentage of participants |
Primary
Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
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.
Time frame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 1, Week 2 (n=12) | 50 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 2, Week 2 (n=12) | 33 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 3, Week 2 (n=12) | 17 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 4, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 5, Week 2 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 1, Week 12 (n=12) | 67 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 2, Week 12 (n=12) | 25 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 3, Week 12 (n=12) | 8 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 4, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 5, Week 12 (n=12) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 1, Month 6 (n=11) | 55 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 2, Month 6 (n=11) | 36 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 3, Month 6 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 4, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 5, Month 6 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 1, Month 9 (n=11) | 64 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 2, Month 9 (n=11) | 27 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 3, Month 9 (n=11) | 9 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 4, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 5, Month 9 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 1, Month 12 (n=10) | 60 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 2, Month 12 (n=10) | 40 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 3, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 4, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 5, Month 12 (n=10) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 1, Month 15 (n=11) | 100 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 2, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 3, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port | Category 4, Month 15 (n=11) | 0 percentage of participants |
| Accu-Chek DiaPort | 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
Suitability of the Device - Overall Suitability Score
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).
Time frame: Week 12
Population: All participants who received the implant were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Accu-Chek DiaPort | Suitability of the Device - Overall Suitability Score | 2.00 units on a scale | Standard Deviation 0.74 |
Secondary
Continuous Glucose Measurement (CGM) - Glucose Levels
CGM measurements were performed using a diurnal CGM sensor and group means were calculated over 10 minute periods of the CGM measurements.
Time frame: Screening, Week 12 and 6 Months
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Accu-Chek DiaPort | Continuous Glucose Measurement (CGM) - Glucose Levels | Screening (n=12) | 200.7 mg/dL | Standard Deviation 39.6 |
| Accu-Chek DiaPort | Continuous Glucose Measurement (CGM) - Glucose Levels | Week 12 (n=12) | 174.3 mg/dL | Standard Deviation 20.3 |
| Accu-Chek DiaPort | Continuous Glucose Measurement (CGM) - Glucose Levels | Month 6 (n=11) | 173.4 mg/dL | Standard Deviation 24.9 |
Secondary
Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
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.
Time frame: Week 12
Population: All participants were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Needing Instruction for Fixation disc | 92 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Needing Instruction for Infusion set | 92 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | With Pain after implantation | 75 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Moderate pain after implantation during 4 - 6 days | 17 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Moderate pain after implantation 7 days or more | 17 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Disconnection of infusion set from port-daily | 33 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Disconnection of infusion set from port-never | 33 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Stopped pump during temporal disconnection | 17 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Used handling aid for temporal storage | 83 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Reason for temporal disconnection-sex | 33 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Reason for temporal disconnection-shower | 83 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Reason for temporal disconnection-sport | 17 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Changed fixation disc after ≥3 days | 75 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Changed infusion set after ≥4 days | 83 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Changed cartride and infusion set simultaneously | 92 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Changed fixation disc and cartridge simultaneously | 55 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Cleaned skin around port-daily | 50 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Cleaned skin around port-every second day | 17 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Cleaned skin around port-3rd to 5th day | 17 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Cleaned skin around port-with saline | 58 percentage of participants |
| Accu-Chek DiaPort | Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response | Cleaned skin around port-with alcohol | 50 percentage of participants |
Secondary
Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
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.
Time frame: Screening, Week 12 and Months 6, 9 and 12
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Accu-Chek DiaPort | Glycemic Variability: Percent Coefficient of Variation in Blood Glucose | SMBG - Screening (n=12) | 45.1 percent of mean glucose value | Standard Deviation 9.8 |
| Accu-Chek DiaPort | 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 |
| Accu-Chek DiaPort | 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 |
| Accu-Chek DiaPort | 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 |
| Accu-Chek DiaPort | 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 |
| Accu-Chek DiaPort | Glycemic Variability: Percent Coefficient of Variation in Blood Glucose | CGM - Screening (n=12) | 40.3 percent of mean glucose value | Standard Deviation 8.5 |
| Accu-Chek DiaPort | Glycemic Variability: Percent Coefficient of Variation in Blood Glucose | CGM - Week 12 (n=12) | 37.8 percent of mean glucose value | Standard Deviation 9 |
| Accu-Chek DiaPort | 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
Hemoglobin A1c Levels
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.
Time frame: Screening, Week 12 and Months 6, 9 and 12
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Accu-Chek DiaPort | Hemoglobin A1c Levels | Screening (n=12) | 8.99 percent of glycated hemoglobin | Standard Deviation 1.13 |
| Accu-Chek DiaPort | Hemoglobin A1c Levels | Week 12 (n=12) | 7.99 percent of glycated hemoglobin | Standard Deviation 0.97 |
| Accu-Chek DiaPort | Hemoglobin A1c Levels | Month 6 (n=11) | 7.57 percent of glycated hemoglobin | Standard Deviation 0.64 |
| Accu-Chek DiaPort | Hemoglobin A1c Levels | Month 9 (n=11) | 7.73 percent of glycated hemoglobin | Standard Deviation 1.01 |
| Accu-Chek DiaPort | Hemoglobin A1c Levels | Month 12 (n=10) | 8.38 percent of glycated hemoglobin | Standard Deviation 1.15 |
Secondary
Insulin Doses Dispensed From Insulin Pump
Total insulin dose (in international units per milliliter \[IU/mL\]) from pump was measured per day as mean per day measured over 7 days.
Time frame: Screening, Week 12 and Months 6, 9 and 12
Population: All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily bolus insulin dose - Month 9 (n=11) | 33.7 IU/mL | Standard Deviation 33.2 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily insulin dose - Screening (n=12) | 49.3 IU/mL | Standard Deviation 53.2 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily insulin dose - Week 12 (n=12) | 45.2 IU/mL | Standard Deviation 30.1 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily insulin dose - Month 6 (n=11) | 43.8 IU/mL | Standard Deviation 32.7 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily insulin dose - Month 9 (n=11) | 43.8 IU/mL | Standard Deviation 36.4 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily insulin dose - Month 12 (n=10) | 40.8 IU/mL | Standard Deviation 34.5 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily basal insulin dose - Screening (n=12) | 9.6 IU/mL | Standard Deviation 4.8 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily basal insulin dose - Week 12 (n=12) | 11.1 IU/mL | Standard Deviation 5.1 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily basal insulin dose - Month 6 (n=11) | 9.9 IU/mL | Standard Deviation 4.5 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily basal insulin dose - Month 9 (n=11) | 10.1 IU/mL | Standard Deviation 4.5 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily basal insulin dose - Month 12 (n=10) | 9.3 IU/mL | Standard Deviation 4.6 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily bolus insulin dose - Screening (n=12) | 39.6 IU/mL | Standard Deviation 49.3 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily bolus insulin dose - Week 12 (n=12) | 34.1 IU/mL | Standard Deviation 26.9 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily bolus insulin dose - Month 6 (n=11) | 33.8 IU/mL | Standard Deviation 29.6 |
| Accu-Chek DiaPort | Insulin Doses Dispensed From Insulin Pump | Daily bolus insulin dose - Month 12 (n=10) | 31.6 IU/mL | Standard Deviation 31 |
Secondary
Percentage of Participants Achieving Target Glucose Levels
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.
Time frame: Screening, Week 12 and 6 Months
Population: All participants were included in the study; n= number of participants analyzed for the given parameter at the specified timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Within target range - Screening (n=12) | 44.6 percentage of participants | Standard Deviation 14.4 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Within target range - Week 12 (n=12) | 56.5 percentage of participants | Standard Deviation 12 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Within target range - Month 6 (n=11) | 58.3 percentage of participants | Standard Deviation 13.1 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Above target range - Screening (n=12) | 52.6 percentage of participants | Standard Deviation 15.5 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Above target range - Week 12 (n=12) | 39.9 percentage of participants | Standard Deviation 11.7 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Above target range - Month 6 (n=11) | 37.8 percentage of participants | Standard Deviation 13.5 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Below target range - Screening (n=12) | 2.9 percentage of participants | Standard Deviation 2.8 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Below target range - Week 12 (n=12) | 3.6 percentage of participants | Standard Deviation 3.7 |
| Accu-Chek DiaPort | Percentage of Participants Achieving Target Glucose Levels | Below target range - Month 6 (n=11) | 3.8 percentage of participants | Standard Deviation 4.8 |
Secondary
Self Monitored Blood Glucose Levels
Participants monitored glucose levels on a daily basis and recorded for evaluation. Glucose levels are measured as milligrams per deciliter (mg/dL)
Time frame: Screening, Week 12 and Months 6, 9 and 12
Population: All participants were included in analysis; n= number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Accu-Chek DiaPort | Self Monitored Blood Glucose Levels | Screening (n=12) | 185.1 mg/dL | Standard Deviation 33 |
| Accu-Chek DiaPort | Self Monitored Blood Glucose Levels | Week 12 (n=12) | 176.6 mg/dL | Standard Deviation 31.1 |
| Accu-Chek DiaPort | Self Monitored Blood Glucose Levels | Month 6 (n=11) | 164.1 mg/dL | Standard Deviation 30.6 |
| Accu-Chek DiaPort | Self Monitored Blood Glucose Levels | Month 9 (n=11) | 174.7 mg/dL | Standard Deviation 44.2 |
| Accu-Chek DiaPort | Self Monitored Blood Glucose Levels | Month 12 (n=10) | 184.6 mg/dL | Standard Deviation 36.6 |