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- Title
Intraperitoneal (IP) Insulin Infusion versus Subcutaneous (SC) Insulin Administration in Type 1 Diabetes (T1DM): Preliminary Results of a Prospective Randomized Cross-Over Trial.
- Authors
Logtenberg, Susan J.; Kleefstra, Nanne; Houweling, Sebastiaan T.; Groenier, Klaas H.; van Ballegooie, Evert; Bilo, Henk J.
- Abstract
As part of an ongoing cross-over trial to compare the effects of IP insulin to SC insulin in poorly controlled T1DM (HbA[sub 1c]>7.5% and/or ≥ 5 hypoglycemic events/wk), preliminary data on glycemic control, quality of life (QOL) and treatment satisfaction (TS) are reported of 20 subjects enrolled thus far. Design: a 3 month run-in phase is followed by two 6 months treatment phases. At the end of the run-in phase, subjects are randomized to receive insulin either by IP (implantable pump; MIP 2007C, Medtronic) or SC (CSII or MDI) administration. In the 2nd treatment phase, subjects cross over to the other treatment mode. Enrolment started March 2006. Mean age 43.8±11.6 years; 8M, 12F; mean diabetes duration 22.9±10.9 years; mean HbA[sub 1c] 8.6±1.2%; HbA[sub 1c]>7.5% in 16 subjects; hypoglycemic events ≥ 5/wk in 12 subjects; 18 subjects used CSII, 2 used MDI at trial enrolment. Dec 31st 2006, 19 subjects had completed the 1st half of the 1st treatment phase. One subject was lost to follow-up (IP-group). Ten subjects had completed the 1st treatment phase. Change over time was evaluated using General Linear Model procedures, adjusting for baseline values. There were no baseline differences between groups with respect to HbA[sub 1c], BMI, diabetes duration, blood pressure, QOL or TS. After 3 months, HbA[sub 1c] dropped 0.53% in the IP-group compared to the SC-group (95% CI -1.04, -0.03; p=0.04) and time spent in euglycemia increased 17.2% in the IP-group compared to the SC-group (95% CI 0.5, 33.9; p<0.05). After 6 months, TS increased 9.8 points (95% CI 2.7, 16.9; p=0.01) in the IP-group compared to the SC-group. Neither HbA[sub 1c] nor time in euglycemia nor QOL did differ significantly between groups after 6 months. Interim data suggest that IP insulin infusion improves glycemic control and increases time in euglycemia in otherwise poorly controlled T1DM. Further evaluation will determine whether these effects are sustainable.
- Subjects
INSULIN; TREATMENT of diabetes; RANDOMIZED controlled trials; QUALITY of life; PATIENT satisfaction
- Publication
Diabetes, 2007, Vol 56, pA120
- ISSN
0012-1797
- Publication type
Article