Diabetes Mellitus, Type 1NCT00790088
INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy
An observational study of Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 26 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 274 participants
- Where
- 26 sitesin 14 countries
- Study dates
- Feb 2009to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with type 1 diabetes on insulin infusion pump therapy
Who may be able to join
- Patient (and/or legal representative) has signed Patient Informed Consent (PIC)
- Patient was diagnosed with Type 1 DM and has been on insulin infusion pump therapy (without any additional insulin injection) for at least 6 months prior to signature of the PIC
- The treating physician decided independently of the study to prescribe non-blinded continuous glucose monitoring as part of the patient's pump therapy for at least 10% of the study time (estimated as days per month)
Who cannot join
- Participation in any other clinical trial - currently and/or in the last 3 months prior to signature of informed consent
- Patient has preliminary experience with non-blinded continuous glucose monitoring prior to signature of informed consent (not naïve to non-blinded continuous glucose monitoring)
- For children: no reliable contact person
Trial locations and contacts
26 sites in 14 countries.
26 sites in 14 countries
France3 sites
Hôpital de Dax
Dax
Centre Hospitalier de Haguenau
Haguenau
Centre Hospitalier La Rochelle
La Rochelle
Hungary3 sites
Réthy Pál Hospital
Békéscsaba, 5600
Péterfy Hospital, Outpatient Clinic
Budapest, 1076
Josa András Teaching Hospital
Nyíregyháza
Poland3 sites
Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp
Bialystok
Specjalistyczna Praktyka Lekarska
Gliwice
Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz
Krakow
Spain3 sites
Hospital Universitario Infanta Cristina
Badajoz
Complejo Hosp. Santiago De Compostela
Santiago de Compostela
Hospital Virgen del Rocio
Seville
Italy2 sites
Sacco Hospital, University of Milan
Milan, 20157
Ospedale S. Camillo Forlanini
Roma
Slovakia2 sites
TopCare s.r.o.
Košice
National Institute of Endocrinology
Ľubochňa
Austria1 site
LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I
Salzburg, 5010
About this study
Official title: International Report on Routine Practice of Sensor-enabled Pump Therapy
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, continuous glucose monitoring, sensor-augmented pump therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every 3 months
HbA1c
Measured: every 3 months
Percentage of Patients Achieving HbA1c < 7%
Measured: every 3 months
Percentage of Patients Achieving HbA1c < 7.5%
Measured: every 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at baseline, after 3 and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionMar 2012
- Study completionMay 2012
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.
- 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
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ohad Cohen, Prof, Principal investigator, Chaim Sheba Medical Center, Tel Hashomer, IsraelKirsten Noergaard, MD, Principal investigator, Hvidovre Hospital, Hvidovre, DenmarkAndrea Scaramuzza, MD, Principal investigator, Sacco Hospital, University of Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790088
- Sponsor's protocol ID
- EUR04
- Status last verified
- Oct 2018
- First submitted
- 12 Nov 2008
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Report on Routine Practice of Sensor-enabled Pump Therapy
- ClinicalTrials.gov ID
- NCT00790088
- Acronym / sponsor ID
- EUR04
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, continuous glucose monitoring, sensor-augmented pump therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 20 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 1 diabetes on insulin infusion pump therapy
Key inclusion criteria (3 listed)
- Patient (and/or legal representative) has signed Patient Informed Consent (PIC)
- Patient was diagnosed with Type 1 DM and has been on insulin infusion pump therapy (without any additional insulin injection) for at least 6 months prior to signature of the PIC
- The treating physician decided independently of the study to prescribe non-blinded continuous glucose monitoring as part of the patient's pump therapy for at least 10% of the study time (estimated as days per month)
Key exclusion criteria (3 listed)
- Participation in any other clinical trial - currently and/or in the last 3 months prior to signature of informed consent
- Patient has preliminary experience with non-blinded continuous glucose monitoring prior to signature of informed consent (not naïve to non-blinded continuous glucose monitoring)
- For children: no reliable contact person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency as Percentage of Sensor Usage
Time frame: every 3 months
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
HbA1c
Time frame: every 3 months
Percentage of Patients Achieving HbA1c < 7%
Time frame: every 3 months
Percentage of Patients Achieving HbA1c < 7.5%
Time frame: every 3 months
3 secondary outcomes
Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
Time frame: at baseline, after 6 and after 12 months
Fear of Hypoglycemia Survey (HFS-II) - Worry Score
Time frame: at baseline, after 6 and after 12 months
Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
Time frame: at baseline, after 3 and after 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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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.
Ohad Cohen, Prof principal investigator
Chaim Sheba Medical Center, Tel Hashomer, Israel
Kirsten Noergaard, MD principal investigator
Hvidovre Hospital, Hvidovre, Denmark
Andrea Scaramuzza, MD principal investigator
Sacco Hospital, University of Milan, Italy
26 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 26 sites in 14 countries.
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 3 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Hungary, Poland, Spain, Belgium and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 20 Feb 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?
Frequency as Percentage of Sensor Usage (time frame: every 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2019.