Author(s)
Gough H1, Castaneda J2, Hommel E3, Olsen BS4, Battelino T5, Conget I6, Schutz-Fuhrmann I7, Hoogma R8, Schierloh U9, Sulli N10, Bolinder J11, de Portu S121Medtronic International Trading Sarl, Tolochenaz, Vaud, Switzerland, 2Medtronic Bakken Research Center, Maastricht, Netherlands, 3Steno Diabetes Center, Gentofte, Denmark, 4Herlev Hospital, Herlev, Denmark, 5University Children's Hospital, Ljubljana, Slovenia, 6ICMDM Hospital Clínic i Universitari, Barcelona, Spain, 7Hospital Hietzing, Vienna, Austria, 8Groene Hart Ziekenhuis, Gouda , Netherlands, 9Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg, 10Policlinico Umberto I, Rome, Italy, 11Karolinska University Hospital, Stockholm, Sweden, 12Medtronic International Sàrl, Tolochenaz, Switzerland
OBJECTIVES: To evaluate the metabolic effect of adding continuous glucose monitoring (CGM) to insulin pump therapy and the impact on Health Related Quality of Life (HRQOL), Treatment Satisfaction (TS). METHODS: Eighty-one adults & seventy-two children with Type 1 diabetes participated in a multicenter, randomized, controlled, cross-over study. Following a one month run-in period, subjects were randomized to CGM Sensor-ON or Sensor-OFF arms for six months, following a four month wash-out period subjects crossed over to the other treatment arm for six additional months. Diabetes Treatment Satisfaction Questionnaire (status version; DTSQs) in adults and Pediatric Quality of Life Inventory (PedsQL) in children were collected at baseline and end of each treatment period. Analyses were controlled for baseline values, and there was no sequence effect observed in either age group. RESULTS: Sensor use significantly improved glycemic control resulting in an HbA1c reduction of -0.43% in the intention to treat population (ITT). Adult TS improved significantly (p<0.012) compared to baseline, favoring Sensor-ON in ITT. There was no significant difference in the perceived frequency of hypo- or hyperglycemia with CGM. Sensor use was positively associated with TS (p=0.027) in the per-protocol group. There was no significant difference in children’s perceived overall HRQOL between Sensor-ON and Sensor-OFF. Individual items of the PedsQL and DTSQs were analyzed separately. CONCLUSIONS: Adding CGM to pump therapy significantly improves metabolic control. CGM use significantly improves treatment satisfaction in adults, and had no impact on the overall HRQOL in children. Increased usage of the sensor was associated with an increase of the TS score in adults.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PMD78
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Diabetes/Endocrine/Metabolic Disorders