INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

International Report on Routine Practice of Sensor-enabled Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790088
• Other study ID #: EUR04
• Status: Completed
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: October 2018
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
Austria	LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I	Salzburg
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	AZ Imelda	Bonheiden
Denmark	Fredericia Hospital	Fredericia
Denmark	Hvidovre Hospital	Hvidovre
France	Hôpital de Dax	Dax
France	Centre Hospitalier de Haguenau	Haguenau
France	Centre Hospitalier La Rochelle	La Rochelle
Hungary	Réthy Pál Hospital	Békéscsaba
Hungary	Péterfy Hospital, Outpatient Clinic	Budapest
Hungary	Josa András Teaching Hospital	Nyiregyhaza
Israel	Chaim Sheba Medical center	Tel Hashomer, Ramat Gan
Italy	Sacco Hospital, University of Milan	Milan
Italy	Ospedale S. Camillo Forlanini	Roma
Lithuania	Kaunas University Hospital	Kaunas
Poland	Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp	Bialystok
Poland	Specjalistyczna Praktyka Lekarska	Gliwice
Poland	Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz	Krakow
Serbia	Clinical Center of Serbia	Belgrade
Slovakia	TopCare s.r.o.	Kosice
Slovakia	National Institute of Endocrinology	Lubochna
Slovenia	University Childrens Hospital	Ljubjana
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Complejo Hosp. Santiago De Compostela	Santiago de Compostela
Spain	Hospital Virgen del Rocio	Sevilla
Sweden	Astrid Lindgrens Barnsjukhus	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Hungary,  Israel,  Italy,  Lithuania,  Poland,  Serbia,  Slovakia,  Slovenia,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	every 3 months
Primary	HbA1c		every 3 months
Primary	Percentage of Patients Achieving HbA1c < 7%		every 3 months
Primary	Percentage of Patients Achieving HbA1c < 7.5%		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.	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.	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.	at baseline, after 3 and after 12 months