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The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.
Pump therapy has been established as "gold standard" for insulin delivery offering improvements over multiple daily insulin injections, but there is a proportion of patients for whom the Continuous Subcutaneous Insulin Infusion (CSII) has not been completely successful therapy leaving some room for improvement of the glucose level of those patients. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology that can facilitate optimal glucose control in type 1 diabetes. Numerous randomized control trials have demonstrated the safety and efficacy of real-time CGM in both sub-optimally and well-controlled type 1 diabetes. In all these trials, the benefits of CGM correlate with frequent sensor wear and more advanced age. In clinical practice, the sensor-augmented pump therapy (SAP therapy) is indicated for patients who cannot achieve good metabolic control on CSII, who have a history of severe hypoglycemia and/or hypoglycemia unawareness, or who desire increased flexibility in their daily lives while maintaining or even improving their HbA1c levels.
This was a post-market release, minimally interventional study. All the study devices and related software were CE-marked and commercially available in the countries participating to the study. The devices were prescribed and reimbursed, if applicable, according to routine practice.
The gathered information during this study may help to define which patient groups benefit the most from the treatment with SAP therapy systems. The real-life results of these descriptive analyses will aid improvement of guidelines helping the medical community to better choose the right patient population and treatment patterns. Moreover, based on these real-life data, hypotheses could be defined when addressing further research questions.
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency as Percentage of Sensor Usage | To calculate the percentage of time that sensors were used during 3 months: the total number of recorded sensor readings during 3 months was divided by the theoretical number of sensor readings that would be observed if sensor was worn every day of using pump to deliver insulin during the same period (ie, observed readings / (theoretical 288 readings per day x nber of days with insulin use)) and multiplied by 100 | every 3 months |
| HbA1c | every 3 months | |
| Percentage of Patients Achieving HbA1c < 7% | every 3 months | |
| Percentage of Patients Achieving HbA1c < 7.5% | every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | sub-group of patients (adults only in Hungary and Denmark) were asked to answer the fear of hypoglycemia validated questionnaires. The total HFS-II questionnaire is represented by 33 items. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always.The total HFS-II score ranges from 0 to 132. Lower score at 6 months or 12 months compared to baseline represents a better outcome. The HFS-II questionnaire is divided into 2 subscales: the behavior and the worry subscales. The behavior score is represented by 15 items and ranges from 0 to 60. Lower score at 6 months or 12 months compared to baseline represents a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 1 diabetes on insulin infusion pump therapy
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| Name | Affiliation | Role |
|---|---|---|
| Ohad Cohen, Prof | Chaim Sheba Medical Center, Tel Hashomer, Israel | Principal Investigator |
| Kirsten Noergaard, MD | Hvidovre Hospital, Hvidovre, Denmark | Principal Investigator |
| Andrea Scaramuzza, MD | Sacco Hospital, University of Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I | Salzburg | 5010 | Austria | |||
Nørgaard K et al. Routine sensor-augmented pump therapy in type 1 diabetes: the INTERPRET study. Diabetes Technol Ther. 2013 Apr;15(4):273-80. doi: 10.1089/dia.2012.0288. Epub 2013 Feb 25.
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At baseline, few patients had to be excluded from analyses due to major protocol deviations such as missing patient informed consent, CSII therapy for less than 6 months, prior experience with SAP therapy, and no eCRF data information available. Hence 263 patients were eligible for analyses at baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensor-augmented Pump | CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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capillary blood samples for HbA1c analysis
| at baseline, after 6 and after 12 months |
| Fear of Hypoglycemia Survey (HFS-II) - Worry Score | sub-group of patients (adults only) were asked to answer the fear of hypoglycemia validated questionnaires. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always. The worry subscale is the mean of 18 items which evaluate the worry score (range from 0 to 72). Lower score at 6 months or 12 months compared to baseline represents a better outcome. | at baseline, after 6 and after 12 months |
| Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | A sub-group of patients (adults) were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs) The treatment satisfaction is measured by means of the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 6 to 0. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month or 12 months compared to baseline represents a better outcome. Items 2 (perceived frequency of hyperglycaemia) and 3 (perceived frequency of hypoglycaemia) are treated individually in data analysis. Lower score at 6 months or 12 months compared to baseline represents a better outcome. | at baseline, after 3 and after 12 months |
| Universitair Ziekenhuis Antwerpen |
| Antwerp |
| Belgium |
| AZ Imelda | Bonheiden | Belgium |
| Fredericia Hospital | Fredericia | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Hôpital de Dax | Dax | France |
| Centre Hospitalier de Haguenau | Haguenau | France |
| Centre Hospitalier La Rochelle | La Rochelle | France |
| Réthy Pál Hospital | Békéscsaba | 5600 | Hungary |
| Péterfy Hospital, Outpatient Clinic | Budapest | 1076 | Hungary |
| Josa András Teaching Hospital | Nyíregyháza | Hungary |
| Chaim Sheba Medical center | Tel Hashomer, Ramat Gan | 52621 | Israel |
| Sacco Hospital, University of Milan | Milan | 20157 | Italy |
| Ospedale S. Camillo Forlanini | Roma | Italy |
| Kaunas University Hospital | Kaunas | Lithuania |
| Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp | Bialystok | Poland |
| Specjalistyczna Praktyka Lekarska | Gliwice | Poland |
| Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz | Krakow | Poland |
| Clinical Center of Serbia | Belgrade | Serbia |
| TopCare s.r.o. | Košice | Slovakia |
| National Institute of Endocrinology | Ľubochňa | Slovakia |
| University Childrens Hospital | Ljubjana | Slovenia |
| Hospital Universitario Infanta Cristina | Badajoz | Spain |
| Complejo Hosp. Santiago De Compostela | Santiago de Compostela | Spain |
| Hospital Virgen del Rocio | Seville | Spain |
| Astrid Lindgrens Barnsjukhus | Stockholm | Sweden |
| Eligible for Data Analysis |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensor-augmented Pump | CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Age groups are: 0-7; 8-12; 13-17; 18-24; >24 | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Frequency as Percentage of Sensor Usage | To calculate the percentage of time that sensors were used during 3 months: the total number of recorded sensor readings during 3 months was divided by the theoretical number of sensor readings that would be observed if sensor was worn every day of using pump to deliver insulin during the same period (ie, observed readings / (theoretical 288 readings per day x nber of days with insulin use)) and multiplied by 100 | Posted | Mean | Standard Deviation | % of time | every 3 months |
|
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| Primary | HbA1c | Posted | Mean | Standard Deviation | percent | every 3 months |
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| Primary | Percentage of Patients Achieving HbA1c < 7% | Posted | Number | percent of patients | every 3 months |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | sub-group of patients (adults only in Hungary and Denmark) were asked to answer the fear of hypoglycemia validated questionnaires. The total HFS-II questionnaire is represented by 33 items. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always.The total HFS-II score ranges from 0 to 132. Lower score at 6 months or 12 months compared to baseline represents a better outcome. The HFS-II questionnaire is divided into 2 subscales: the behavior and the worry subscales. The behavior score is represented by 15 items and ranges from 0 to 60. Lower score at 6 months or 12 months compared to baseline represents a better outcome. | Posted | Mean | Standard Deviation | Score | at baseline, after 6 and after 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Fear of Hypoglycemia Survey (HFS-II) - Worry Score | sub-group of patients (adults only) were asked to answer the fear of hypoglycemia validated questionnaires. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always. The worry subscale is the mean of 18 items which evaluate the worry score (range from 0 to 72). Lower score at 6 months or 12 months compared to baseline represents a better outcome. | Posted | Mean | Standard Deviation | Score | at baseline, after 6 and after 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | A sub-group of patients (adults) were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs) The treatment satisfaction is measured by means of the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 6 to 0. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month or 12 months compared to baseline represents a better outcome. Items 2 (perceived frequency of hyperglycaemia) and 3 (perceived frequency of hypoglycaemia) are treated individually in data analysis. Lower score at 6 months or 12 months compared to baseline represents a better outcome. | Posted | Mean | Standard Deviation | score | at baseline, after 3 and after 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Achieving HbA1c < 7.5% | Posted | Number | percent of patients | every 3 months |
|
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During the 12Months follow-up
Only Serious adverse events were collected
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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 | Sensor-augmented Pump | CSII patient who were prescribed the use of continuous glucose monitoring (CGM) for at least 10% of the time | 24 | 263 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Endocrine disorders | Systematic Assessment | defined as blood glucose >250 mg/dL [>13.9 mmol/L] with either low serum bicarbonate [<15 mEq/L] or low pH [<7.3] and either ketonemia or ketonuria and requiring treatment within a health-care facility |
| |
| Severe hypoglycemia | Endocrine disorders | Systematic Assessment | defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose value <50mg/dL [<2.8 mmol/L] |
| |
| Other diabetes-related AE | Endocrine disorders | Systematic Assessment | angioplasty, diabetic foot ulcer; ischemic heart disease; pancreas and liver transplantations, suicide attempt, poor glycemic control |
| |
| Non Diabetes-related serious adverse events | Endocrine disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Odile Carrette | Medtronic Int. Trading SaRL | +41218038119 | odile.osullivan@medtronic.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 13-17 |
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| 18-24 |
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| >24 |
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| Spain |
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| Lithuania |
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| Austria |
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| Israel |
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| Italy |
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| Slovakia |
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| France |
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| Poland |
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| Hungary |
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| Belgium |
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| Denmark |
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| Sweden |
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| Czechia |
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| Title | Measurements |
|---|---|
|
| 9 months - 12 months |
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| baseline - 12 months |
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| 3Months |
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| 6Months |
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| 9Months |
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| 12Months |
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| 3 months |
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| 6 months |
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| 9 months |
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| 12 months |
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| 3 months |
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| 6 months |
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| 9 months |
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| 12 months |
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