Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study|
- Time in Target Blood Glucose Range [ Time Frame: Day 1-15 compared with Day 60-74 ] [ Designated as safety issue: No ]Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
- HbA1c [ Time Frame: Day 1 compared with Day 74 ] [ Designated as safety issue: No ]
HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).
The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. [ Time Frame: Day 60 compared to day 1 ] [ Designated as safety issue: No ]
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).
The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.
|Study Start Date:||January 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
Device: FreeStyle InsuLinx
FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
Device: FreeStyle Freedom Lite
FreeStyle Freedom Lite is a blood glucose meter
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519466
|Diabetes Zentrum Mergentheim|
|Bad Mergentheim, Germany, 97980|
|Diabetes-Zentrum für Kinder und Jugendliche|
|Hannover, Germany, 30173|
|Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm|
|Ulm, Germany, D-89081|
|VU University Medical Centre (VUMC)|
|Amsterdam, Netherlands, 1007 MB|
|Principal Investigator:||Prof. Michaela Diamant||VU University Medical Centre (VUMC)|