N/A
Completed N=153
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00598663 ↗
Enrolled (actual)
153
Serious AEs
3.6%
Results posted
Sep 2019
Primary outcomePrimary: HbA1c at 6 Month — 8.47; 8.04 percentage of glycosylated hemoglobin — p=<0.0001
Summary
The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c at 6 Month |
8.47; 8.04 | <0.0001 sig |
| SECONDARY Glycemic Variability |
77.16; 71.58 | — |
| SECONDARY Number of Severe Hypoglycemia Events |
2; 4 | — |
| SECONDARY Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l) |
669; 774 | — |
| SECONDARY Postprandial Glycaemia |
157.7; 160.4 | — |
| SECONDARY Pediatric Quality of Life Inventory (Vers 4.0; PedsQL) |
85.11; 84.75 | — |
| SECONDARY Diabetic Ketoacidosis Events |
3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
- Sub-optimal glycemic control (7.5% 35 and children Body Mass Index > 2 standard deviations. for age) as assessed by the investigator.
- Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
- For pediatric subjects: does not have a reliable support person.
- Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
- Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
Data sourced from ClinicalTrials.gov (NCT00598663). 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.