N/A
Completed N=274
INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00790088 ↗
Enrolled (actual)
274
Serious AEs
9.1%
Results posted
Feb 2019
Primary outcomePrimary: Frequency as Percentage of Sensor Usage — 37; 31; 28; 27 % of time
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency as Percentage of Sensor Usage |
37; 31; 28; 27; 30 | — |
| PRIMARY HbA1c |
8.1; 7.87; 7.9; 7.98; 8.05 | — |
| PRIMARY Percentage of Patients Achieving HbA1c < 7% |
18.25; 18.5; 18.22; 17.72; 16.02 | — |
| PRIMARY Percentage of Patients Achieving HbA1c < 7.5% |
28.52; 36.22; 32.79; 31.65; 33.33 | — |
| SECONDARY Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score |
37; 32.74; 28.95; 16.03; 14.56; 13.35 | — |
| SECONDARY Fear of Hypoglycemia Survey (HFS-II) - Worry Score |
23.39; 20.65; 18.40 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) |
31.42; 30.80; 32; 2.18; 2.5; 2.03 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00790088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.