INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy
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| ClinicalTrials.gov Identifier: NCT00790088 |
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Recruitment Status :
Completed
First Posted : November 13, 2008
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
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| Condition or disease |
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| Diabetes Mellitus, Type 1 |
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 Type : | Observational |
| Actual Enrollment : | 274 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | International Report on Routine Practice of Sensor-enabled Pump Therapy |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | May 2012 |
- 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 ]
- Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score [ Time Frame: at baseline, after 6 and after 12 months ]
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.
- Fear of Hypoglycemia Survey (HFS-II) - Worry Score [ Time Frame: at baseline, after 6 and after 12 months ]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.
- Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) [ Time Frame: at baseline, after 3 and after 12 months ]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.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790088
Show 26 study locations
| Principal Investigator: | 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 |
| Responsible Party: | Medtronic Diabetes |
| ClinicalTrials.gov Identifier: | NCT00790088 |
| Other Study ID Numbers: |
EUR04 |
| First Posted: | November 13, 2008 Key Record Dates |
| Results First Posted: | February 20, 2019 |
| Last Update Posted: | February 20, 2019 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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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Diabetes Mellitus, Type 1 continuous glucose monitoring sensor-augmented pump therapy |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |