Trial Outcomes & Findings for Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients (NCT NCT01588106)

Results Overview

Recruitment status

COMPLETED

Target enrollment

154 participants

Primary outcome timeframe

Baseline, after 9 months

Results posted on

2017-03-09

Subjects were screened and enrolled in 16 sites across Germany. Study start date was in June 2012 and recruitment was stopped in November 2014.

Participant milestones
Measure	Test Group- CONTOUR Next USB Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.	Control Group- Standard CONTOUR Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
Overall Study STARTED	78	76
Overall Study COMPLETED	73	72
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal
Measure	Test Group- CONTOUR Next USB Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.	Control Group- Standard CONTOUR Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
Overall Study Withdrawal by Subject	5	4

Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients

Baseline characteristics by cohort
Measure	Test Group- CONTOUR Next USB n=73 Participants Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.	Control Group- Standard CONTOUR n=72 Participants Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.	Total n=145 Participants Total of all reporting groups
Age, Continuous	62.10 Years STANDARD_DEVIATION 10.28 • n=5 Participants	65.66 Years STANDARD_DEVIATION 9.08 • n=7 Participants	63.87 Years STANDARD_DEVIATION 9.83 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	36 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	36 Participants n=7 Participants	79 Participants n=5 Participants
HbA1c value at baseline	8.61 % STANDARD_DEVIATION 0.95 • n=5 Participants	8.47 % STANDARD_DEVIATION 0.97 • n=7 Participants	8.54 % STANDARD_DEVIATION 0.96 • n=5 Participants

Timeframe: Baseline, after 9 months

Population: All participants from whom HbA1c measurements were recorded at baseline and after 9 months.

Outcome measures
Measure	Test Group- CONTOUR Next USB n=58 Participants Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.	Control Group- Standard CONTOUR n=56 Participants Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
Reduction in HbA1c	-0.52 % (unit of HbA1c) Standard Deviation 0.83	-0.14 % (unit of HbA1c) Standard Deviation 0.94

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events
Measure	Test Group- CONTOUR Next USB n=78 participants at risk Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.	Control Group- Standard CONTOUR n=76 participants at risk Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
Vascular disorders severe thrombosis of the portal vein	0.00% 0/78	1.3% 1/76 • Number of events 1

Other adverse events
Measure	Test Group- CONTOUR Next USB n=78 participants at risk Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.	Control Group- Standard CONTOUR n=76 participants at risk Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
Metabolism and nutrition disorders Hypoglycaemia	16.7% 13/78 • Number of events 83	11.8% 9/76 • Number of events 106

GWT-TUD GmbH

Phone: +49 (0) 351 25933 100

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Publications or lectures on the findings of the present clinical trial either as a whole or at individual investigation sites must be approved by the sponsor in advance, and the sponsor reserves the right to review and comment on such documentation before publication.
Publication restrictions are in place

Restriction type: OTHER