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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Participants were implanted with Accu-Chek DiaPort with Infusion Set connected to an Accu-Chek Insulin Pump to perform continuous intraperitoneal insulin delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek DiaPort | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 12 |
| 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. | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
| 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. | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
| Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening, Week 12 and Months 6, 9 and 12 |
| Hemoglobin A1c Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Holzer | Roche Diabetes Care AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bad Heilbrunn | 83670 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received the implant were included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | All participants who received the implant were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
Adverse events were reported from the date of implantation until the end of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diaport replacement | Injury, poisoning and procedural complications | ICD10 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic ischaemic heart disease | Cardiac disorders | ICD10 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 1-800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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. |
| Weeks 2 and 12 and Months 6, 9, 12 and 15 |
| 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. | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
| 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. | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
| 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. | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
| 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. | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
| 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. | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
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.
| Screening, Week 12 and Months 6, 9 and 12 |
| 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) | Screening, Week 12 and Months 6, 9 and 12 |
| 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. | Screening, Week 12 and 6 Months |
| 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. | Screening, Week 12 and Months 6, 9 and 12 |
| 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. | Screening, Week 12 and 6 Months |
| 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. | Week 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| 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. |
|
|
| 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. | All participants were included in the study; number (n)= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of partcipants | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of participants | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of participants | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of participants | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of participants | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of participants | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of participants | Weeks 2 and 12 and Months 6, 9, 12 and 15 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Number | percentage of participants | Weeks 2 and 12 and Months 6, 9, 12 and 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Mean | Standard Deviation | IU/mL | Screening, Week 12 and Months 6, 9 and 12 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Mean | Standard Deviation | percent of glycated hemoglobin | Screening, Week 12 and Months 6, 9 and 12 |
|
|
|
| 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) | All participants were included in analysis; n= number of participants analyzed for the given parameter at the specified time point | Posted | Mean | Standard Deviation | mg/dL | Screening, Week 12 and Months 6, 9 and 12 |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Mean | Standard Deviation | mg/dL | Screening, Week 12 and 6 Months |
|
|
|
| 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. | All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Mean | Standard Deviation | percent of mean glucose value | Screening, Week 12 and Months 6, 9 and 12 |
|
|
|
| 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. | All participants were included in the study; n= number of participants analyzed for the given parameter at the specified timepoint | Posted | Mean | Standard Deviation | percentage of participants | Screening, Week 12 and 6 Months |
|
|
|
| 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. | All participants were included in the analysis. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| 8 |
| 12 |
| 12 |
| 12 |
| Complete catheter occlusion | Injury, poisoning and procedural complications | ICD10 | Non-systematic Assessment |
|
| Catheter replacement | Injury, poisoning and procedural complications | ICD10 | Non-systematic Assessment |
|
| Over growth of abdominal catheter | Injury, poisoning and procedural complications | ICD10 | Non-systematic Assessment |
|
| Symptomatic hypoglycemia | Endocrine disorders | ICD10 | Non-systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | ICD10 | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Endocrine disorders | ICD10 | Non-systematic Assessment |
|
| Instable blood sugar | Endocrine disorders | ICD10 | Non-systematic Assessment |
|
| Coronary bypass surgery | Cardiac disorders | ICD10 | Non-systematic Assessment |
|
| Chronic lower respiratory disease | Respiratory, thoracic and mediastinal disorders | ICD10 | Non-systematic Assessment |
|
| Complications of other internal prosthetic devices, implants and grafts | Surgical and medical procedures | ICD10 | Non-systematic Assessment |
|
| Disease of pancreas, unspecified | Gastrointestinal disorders | ICD10 | Non-systematic Assessment |
|
| Diseases of oesophagus, stomach and duodenum | Gastrointestinal disorders | ICD10 | Non-systematic Assessment |
|
| Disorders of lipoprotein metabolism and other lipidaemias | Metabolism and nutrition disorders | ICD10 | Non-systematic Assessment |
|
| Dorsalgia, unspecified | Musculoskeletal and connective tissue disorders | ICD10 | Non-systematic Assessment |
|
| Essential (primary) hypertension | Vascular disorders | ICD10 | Non-systematic Assessment |
|
| Functional diarrhea | Gastrointestinal disorders | ICD10 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | ICD10 | Non-systematic Assessment |
|
| Hypertensive disease | Vascular disorders | ICD10 | Non-systematic Assessment |
|
| Insulin-dependent diabetes mellitus | Metabolism and nutrition disorders | ICD10 | Non-systematic Assessment |
|
| Insulin-dependent diabetes mellitus with renal complications | Metabolism and nutrition disorders | ICD10 | Non-systematic Assessment |
|
| Mental and behavioural disorders | Psychiatric disorders | ICD10 | Non-systematic Assessment |
|
| Metabolic disorders | Metabolism and nutrition disorders | ICD10 | Non-systematic Assessment |
|
| Other and unspecified medical devices associated with adverse incidents | Surgical and medical procedures | ICD10 | Non-systematic Assessment |
|
| Other diseases of intestines | Gastrointestinal disorders | ICD10 | Non-systematic Assessment |
|
| Other diseases of upper respiratory tract | Respiratory, thoracic and mediastinal disorders | ICD10 | Non-systematic Assessment |
|
| Other diseases of urinary system | Renal and urinary disorders | ICD10 | Non-systematic Assessment |
|
| Other soft tissue disorders, not elsewhere classified | Musculoskeletal and connective tissue disorders | ICD10 | Non-systematic Assessment |
|
| Pain localized to upper abdomen | Gastrointestinal disorders | ICD10 | Non-systematic Assessment |
|
| Presents of coronary angioplasty implant and graft | Surgical and medical procedures | ICD10 | Non-systematic Assessment |
|
| Scar conditions and fibrosis of skin | Skin and subcutaneous tissue disorders | ICD10 | Non-systematic Assessment |
|
| Superficial injury of unspecified body region | Injury, poisoning and procedural complications | ICD10 | Non-systematic Assessment |
|
| Symptoms and signs involving the digestive system and abdomen | Gastrointestinal disorders | ICD10 | Non-systematic Assessment |
|
| Urinary tract infection, site not specified | Infections and infestations | ICD10 | Non-systematic Assessment |
|
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.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Category 4, Week 2 (n=12) |
|
| Category 5, Week 2 (n=12) |
|
| Category 1, Week 12 (n=12) |
|
| Category 2, Week 12 (n=12) |
|
| Category 3, Week 12 (n=12) |
|
| Category 4, Week 12 (n=12) |
|
| Category 5, Week 12 (n=12) |
|
| Category 1, Month 6 (n=11) |
|
| Category 2, Month 6 (n=11) |
|
| Category 3, Month 6 (n=11) |
|
| Category 4, Month 6 (n=11) |
|
| Category 5, Month 6 (n=11) |
|
| Category 1, Month 9 (n=11) |
|
| Category 2, Month 9 (n=11) |
|
| Category 3, Month 9 (n=11) |
|
| Category 4, Month 9 (n=11) |
|
| Category 5, Month 9 (n=11) |
|
| Category 1, Month 12 (n=10) |
|
| Category 2, Month 12 (n=10) |
|
| Category 3, Month 12 (n=10) |
|
| Category 4, Month 12 (n=10) |
|
| Category 5, Month 12 (n=10) |
|
| Category 1, Month 15 (n=11) |
|
| Category 2, Month 15 (n=11) |
|
| Category 3, Month 15 (n=11) |
|
| Category 4, Month 15 (n=11) |
|
| Category 5, Month 15 (n=11) |
|
| Title | Measurements |
|---|---|
|
| Category 4, Week 2 (n=12) |
|
| Category 5, Week 2 (n=12) |
|
| Category 1, Week 12 (n=12) |
|
| Category 2, Week 12 (n=12) |
|
| Category 3, Week 12 (n=12) |
|
| Category 4, Week 12 (n=12) |
|
| Category 5, Week 12 (n=12) |
|
| Category 1, Month 6 (n=11) |
|
| Category 2, Month 6 (n=11) |
|
| Category 3, Month 6 (n=11) |
|
| Category 4, Month 6 (n=11) |
|
| Category 5, Month 6 (n=11) |
|
| Category 1, Month 9 (n=11) |
|
| Category 2, Month 9 (n=11) |
|
| Category 3, Month 9 (n=11) |
|
| Category 4, Month 9 (n=11) |
|
| Category 5, Month 9 (n=11) |
|
| Category 1, Month 12 (n=10) |
|
| Category 2, Month 12 (n=10) |
|
| Category 3, Month 12 (n=10) |
|
| Category 4, Month 12 (n=10) |
|
| Category 5, Month 12 (n=10) |
|
| Category 1, Month 15 (n=11) |
|
| Category 2, Month 15 (n=11) |
|
| Category 3, Month 15 (n=11) |
|
| Category 4, Month 15 (n=11) |
|
| Category 5, Month 15 (n=11) |
|
| Title | Measurements |
|---|---|
|
| Category 4, Week 2 (n=12) |
|
| Category 5, Week 2 (n=12) |
|
| Category 1, Week 12 (n=12) |
|
| Category 2, Week 12 (n=12) |
|
| Category 3, Week 12 (n=12) |
|
| Category 4, Week 12 (n=12) |
|
| Category 5, Week 12 (n=12) |
|
| Category 1, Month 6 (n=11) |
|
| Category 2, Month 6 (n=11) |
|
| Category 3, Month 6 (n=11) |
|
| Category 4, Month 6 (n=11) |
|
| Category 5, Month 6 (n=11) |
|
| Category 1, Month 9 (n=11) |
|
| Category 2, Month 9 (n=11) |
|
| Category 3, Month 9 (n=11) |
|
| Category 4, Month 9 (n=11) |
|
| Category 5, Month 9 (n=11) |
|
| Category 1, Month 12 (n=10) |
|
| Category 2, Month 12 (n=10) |
|
| Category 3, Month 12 (n=10) |
|
| Category 4, Month 12 (n=10) |
|
| Category 5, Month 12 (n=10) |
|
| Category 1, Month 15 (n=11) |
|
| Category 2, Month 15 (n=11) |
|
| Category 3, Month 15 (n=11) |
|
| Category 4, Month 15 (n=11) |
|
| Category 5, Month 15 (n=11) |
|
| Title | Measurements |
|---|---|
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| Category 4, Week 2 (n=12) |
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| Category 5, Week 2 (n=12) |
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| Category 1, Week 12 (n=12) |
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| Category 2, Week 12 (n=12) |
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| Category 3, Week 12 (n=12) |
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| Category 4, Week 12 (n=12) |
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| Category 5, Week 12 (n=12) |
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| Category 1, Month 6 (n=11) |
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| Category 2, Month 6 (n=11) |
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| Category 3, Month 6 (n=11) |
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| Category 4, Month 6 (n=11) |
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| Category 5, Month 6 (n=11) |
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| Category 1, Month 9 (n=11) |
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| Category 2, Month 9 (n=11) |
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| Category 3, Month 9 (n=11) |
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| Category 4, Month 9 (n=11) |
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| Category 5, Month 9 (n=11) |
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| Category 1, Month 12 (n=10) |
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| Category 2, Month 12 (n=10) |
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| Category 3, Month 12 (n=10) |
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| Category 4, Month 12 (n=10) |
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| Category 5, Month 12 (n=10) |
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| Category 1, Month 15 (n=11) |
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| Category 2, Month 15 (n=11) |
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| Category 3, Month 15 (n=11) |
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| Category 4, Month 15 (n=11) |
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| Category 5, Month 15 (n=11) |
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| Title | Measurements |
|---|---|
|
| Category 4, Week 2 (n=12) |
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| Category 5, Week 2 (n=12) |
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| Category 1, Week 12 (n=12) |
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| Category 2, Week 12 (n=12) |
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| Category 3, Week 12 (n=12) |
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| Category 4, Week 12 (n=12) |
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| Category 5, Week 12 (n=12) |
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| Category 1, Month 6 (n=11) |
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| Category 2, Month 6 (n=11) |
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| Category 3, Month 6 (n=11) |
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| Category 4, Month 6 (n=11) |
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| Category 5, Month 6 (n=11) |
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| Category 1, Month 9 (n=11) |
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| Category 2, Month 9 (n=11) |
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| Category 3, Month 9 (n=11) |
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| Category 4, Month 9 (n=11) |
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| Category 5, Month 9 (n=11) |
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| Category 1, Month 12 (n=10) |
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| Category 2, Month 12 (n=10) |
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| Category 3, Month 12 (n=10) |
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| Category 4, Month 12 (n=10) |
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| Category 5, Month 12 (n=10) |
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| Category 1, Month 15 (n=11) |
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| Category 2, Month 15 (n=11) |
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| Category 3, Month 15 (n=11) |
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| Category 4, Month 15 (n=11) |
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| Category 5, Month 15 (n=11) |
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| Title | Measurements |
|---|---|
|
| Category 4, Week 2 (n=12) |
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| Category 5, Week 2 (n=12) |
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| Category 1, Week 12 (n=12) |
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| Category 2, Week 12 (n=12) |
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| Category 3, Week 12 (n=12) |
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| Category 4, Week 12 (n=12) |
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| Category 5, Week 12 (n=12) |
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| Category 1, Month 6 (n=11) |
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| Category 2, Month 6 (n=11) |
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| Category 3, Month 6 (n=11) |
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| Category 4, Month 6 (n=11) |
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| Category 5, Month 6 (n=11) |
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| Category 1, Month 9 (n=11) |
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| Category 2, Month 9 (n=11) |
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| Category 3, Month 9 (n=11) |
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| Category 4, Month 9 (n=11) |
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| Category 5, Month 9 (n=11) |
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| Category 1, Month 12 (n=10) |
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| Category 2, Month 12 (n=10) |
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| Category 3, Month 12 (n=10) |
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| Category 4, Month 12 (n=10) |
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| Category 5 Month 12 (n=10) |
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| Category 1, Month 15 (n=11) |
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| Category 2, Month 15 (n=11) |
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| Category 3, Month 15 (n=11) |
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| Category 4, Month 15 (n=11) |
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| Category 5, Month 15 (n=11) |
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| Title | Measurements |
|---|---|
|
| Category 4, Week 2 (n=12) |
|
| Category 5, Week 2 (n=12) |
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| Category 1, Week 12 (n=12) |
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| Category 2, Week 12 (n=12) |
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| Category 3, Week 12 (n=12) |
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| Category 4, Week 12 (n=12) |
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| Category 5, Week 12 (n=12) |
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| Category 1, Month 6 (n=11) |
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| Category 2, Month 6 (n=11) |
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| Category 3, Month 6 (n=11) |
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| Category 4, Month 6 (n=11) |
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| Category 5, Month 6 (n=11) |
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| Category 1, Month 9 (n=11) |
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| Category 2, Month 9 (n=11) |
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| Category 3, Month 9 (n=11) |
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| Category 4, Month 9 (n=11) |
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| Category 5, Month 9 (n=11) |
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| Category 1, Month 12 (n=10) |
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| Category 2, Month 12 (n=10) |
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| Category 3, Month 12 (n=10) |
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| Category 4, Month 12 (n=10) |
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| Category 5, Month 12 (n=10) |
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| Category 1, Month 15 (n=11) |
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| Category 2, Month 15 (n=11) |
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| Category 3, Month 15 (n=11) |
|
| Category 4, Month 15 (n=11) |
|
| Category 5, Month 15 (n=11) |
|
| Title | Measurements |
|---|---|
|
| Category 4, Week 2 (n=12) |
|
| Category 5, Week 2 (n=12) |
|
| Category 1, Week 12 (n=12) |
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| Category 2, Week 12 (n=12) |
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| Category 3, Week 12 (n=12) |
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| Category 4, Week 12 (n=12) |
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| Category 5, Week 12 (n=12) |
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| Category 1, Month 6 (n=11) |
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| Category 2, Month 6 (n=11) |
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| Category 3, Month 6 (n=11) |
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| Category 4, Month 6 (n=11) |
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| Category 5, Month 6 (n=11) |
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| Category 1, Month 9 (n=11) |
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| Category 2, Month 9 (n=11) |
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| Category 3, Month 9 (n=11) |
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| Category 4, Month 9 (n=11) |
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| Category 5, Month 9 (n=11) |
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| Category 1, Month 12 (n=10) |
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| Category 2, Month 12 (n=10) |
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| Category 3, Month 12 (n=10) |
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| Category 4, Month 12 (n=10) |
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| Category 5, Month 12 (n=10) |
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| Category 1, Month 15 (n=11) |
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| Category 2, Month 15 (n=11) |
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| Category 3, Month 15 (n=11) |
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| Category 4, Month 15 (n=11) |
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| Category 5, Month 15 (n=11) |
|
|
| Daily insulin dose - Month 9 (n=11) |
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| Daily insulin dose - Month 12 (n=10) |
|
| Daily basal insulin dose - Screening (n=12) |
|
| Daily basal insulin dose - Week 12 (n=12) |
|
| Daily basal insulin dose - Month 6 (n=11) |
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| Daily basal insulin dose - Month 9 (n=11) |
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| Daily basal insulin dose - Month 12 (n=10) |
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| Daily bolus insulin dose - Screening (n=12) |
|
| Daily bolus insulin dose - Week 12 (n=12) |
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| Daily bolus insulin dose - Month 6 (n=11) |
|
| Daily bolus insulin dose - Month 9 (n=11) |
|
| Daily bolus insulin dose - Month 12 (n=10) |
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| Title | Measurements |
|---|---|
|
| Month 9 (n=11) |
|
| Month 12 (n=10) |
|
| Title | Measurements |
|---|---|
|
| Month 9 (n=11) |
|
| Month 12 (n=10) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| SMBG - Month 9 (n=11) |
|
| SMBG - Month 12 (n=10) |
|
| CGM - Screening (n=12) |
|
| CGM - Week 12 (n=12) |
|
| CGM - Month 6 (n=11) |
|
|
| Above target range - Screening (n=12) |
|
| Above target range - Week 12 (n=12) |
|
| Above target range - Month 6 (n=11) |
|
| Below target range - Screening (n=12) |
|
| Below target range - Week 12 (n=12) |
|
| Below target range - Month 6 (n=11) |
|
| Title | Measurements |
|---|---|
|
| Moderate pain after implantation during 4 - 6 days |
|
| Moderate pain after implantation 7 days or more |
|
| Disconnection of infusion set from port-daily |
|
| Disconnection of infusion set from port-never |
|
| Stopped pump during temporal disconnection |
|
| Used handling aid for temporal storage |
|
| Reason for temporal disconnection-sex |
|
| Reason for temporal disconnection-shower |
|
| Reason for temporal disconnection-sport |
|
| Changed fixation disc after ≥3 days |
|
| Changed infusion set after ≥4 days |
|
| Changed cartride and infusion set simultaneously |
|
| Changed fixation disc and cartridge simultaneously |
|
| Cleaned skin around port-daily |
|
| Cleaned skin around port-every second day |
|
| Cleaned skin around port-3rd to 5th day |
|
| Cleaned skin around port-with saline |
|
| Cleaned skin around port-with alcohol |
|