Diabetes Mellitus, Type 1RANSuPNCT01718522
Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions
An observational study of Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc..
Trial summary
The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP) therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps and continuous glucose monitoring systems in Germany. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- sensor augmented pump (SAP)
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jan 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetes mellitus, type 1
Who may be able to join
- patients with signed informed consent
- Type 1 DM and has been on insulin pump therapy for at least 3 months prior to signature of the informed consent
- patients use CGM component as part as part of the continuous subcutaneous insulin infusion (CSII) therapy for a minimum of 1 month
Who cannot join
- participation in any other trial
- any disease or drug treatment that can interfere with the outcome of sensor usage
- using CGM in CSII < 3 days/week
- patients not willing to sign informed consent
- abuse of alcohol or drugs (exception of nicotine consumption)
- eating disorder, anorexia, bulimia or other mental disorders
About this study
Official title: The Application and Advantage of Sensor Augmented Pump (SAP) Therapy Under Daily Conditions (Registerstudie Zur Anwendung Und Nutzen Der Sensorunterstützten Pumpentherapie (SuP) Unter Alltagsbedingungen)(RANSuP)
The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP) therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps and continuous glucose monitoring systems in Germany.
Read the detailed description
The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump (SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the aim is of this registry is to support:
- obtain reimbursement for SAP therapy in Germany
- building a platform (advisory committee) for discussion of SAP data.
- looking for deficits with implementation of glucose sensor data in diabetes therapy management and development of "follow-up education" materials.
This is a national multi-center, post-market non-interventional prospective study with CE marked and commercially available devices and consumables.
The study will be conducted from March 2012 to April 2013 in Germany. The duration of individual patient participation is 3 to 6 months.
Health outcomes will be measured in approximately 75 patients between 6-65 years old diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The patients are under treatment of Paradigm VEO® without any additional insulin injections and use continuous glucose monitoring, or patients that are not using continuous glucose monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit inquiring the status data (including upload of device data in CareLink software, Hemoglobin A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is optimized based on individual continuous glucose monitoring (CGM) data during a second visit one month later and then a last visit like the first visit in which the status will be determined.
Parameters of glycemic control will be measured, such as the frequency of hypoglycemia (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit 1) and after the visit 2 when an adjustment of the therapy has been discussed with the patient based on the collected CGM results between the two first visits.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- sensor augmented pump (SAP)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensor augmented pump (SAP)Device
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM). Receives: Device: sensor augmented pump (SAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months
Measured: baseline and 3 months
Secondary outcomes (10)
Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months
Measured: Baseline and 3 months
Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months
Measured: Baseline and 3 months
Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months
Measured: Baseline and 3 months
Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months
Measured: Baseline and 3 months
Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months
Area under the curve (AUC) in hypoglycemic region (< 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
Measured: Baseline and 3 months
Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months
Area under the curve (AUC) in hyperglycemic region (>140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
Measured: Baseline and 3 months
Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months
Measured: Baseline and 3 months
Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months
Measured: Baseline and 3 months
Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months
Measured: Baseline and 3 months
Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718522
- Sponsor's protocol ID
- CEN_G_DB_1
- Acronym
- RANSuP
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2012
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application and Advantage of Sensor Augmented Pump (SAP) Therapy Under Daily Conditions (Registerstudie Zur Anwendung Und Nutzen Der Sensorunterstützten Pumpentherapie (SuP) Unter Alltagsbedingungen)(RANSuP)
- ClinicalTrials.gov ID
- NCT01718522
- Acronym / sponsor ID
- RANSuP / CEN_G_DB_1
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 11 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP) therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps and continuous glucose monitoring systems in Germany.
Detailed description
The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump (SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the aim is of this registry is to support:
- obtain reimbursement for SAP therapy in Germany
- building a platform (advisory committee) for discussion of SAP data.
- looking for deficits with implementation of glucose sensor data in diabetes therapy management and development of "follow-up education" materials.
This is a national multi-center, post-market non-interventional prospective study with CE marked and commercially available devices and consumables.
The study will be conducted from March 2012 to April 2013 in Germany. The duration of individual patient participation is 3 to 6 months.
Health outcomes will be measured in approximately 75 patients between 6-65 years old diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The patients are under treatment of Paradigm VEO® without any additional insulin injections and use continuous glucose monitoring, or patients that are not using continuous glucose monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit inquiring the status data (including upload of device data in CareLink software, Hemoglobin A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is optimized based on individual continuous glucose monitoring (CGM) data during a second visit one month later and then a last visit like the first visit in which the status will be determined.
Parameters of glycemic control will be measured, such as the frequency of hypoglycemia (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit 1) and after the visit 2 when an adjustment of the therapy has been discussed with the patient based on the collected CGM results between the two first visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Device: sensor augmented pump (SAP)Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM). |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetes mellitus, type 1
Key inclusion criteria (3 listed)
- patients with signed informed consent
- Type 1 DM and has been on insulin pump therapy for at least 3 months prior to signature of the informed consent
- patients use CGM component as part as part of the continuous subcutaneous insulin infusion (CSII) therapy for a minimum of 1 month
Key exclusion criteria (6 listed)
- participation in any other trial
- any disease or drug treatment that can interfere with the outcome of sensor usage
- using CGM in CSII < 3 days/week
- patients not willing to sign informed consent
- abuse of alcohol or drugs (exception of nicotine consumption)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensor augmented pump (SAP) | Device | Intervention Group |
Primary outcome
Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months
Time frame: baseline and 3 months
10 secondary outcomes
Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months
Time frame: Baseline and 3 months
Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months
Time frame: Baseline and 3 months
Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months
Time frame: Baseline and 3 months
Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months
Time frame: Baseline and 3 months
Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months
Time frame: Baseline and 3 months
Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months
Time frame: Baseline and 3 months
Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months
Time frame: Baseline and 3 months
Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months
Time frame: Baseline and 3 months
Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months
Time frame: Baseline and 3 months
Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationTsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.