Improved Glycemic Control With Intraperitoneal Versus Subcutaneous Insulin in Type 1 Diabetes
A randomized controlled trial
- Susan J. Logtenberg, MD1,
- Nanne Kleefstra, MD1,2,
- Sebastiaan T. Houweling, MD, PHD1,2,3,
- Klaas H. Groenier, PHD4,5,
- Reinold O. Gans, MD, PHD5,6,
- Evert van Ballegooie2,† and
- Henk J. Bilo, MD, PHD, FRCP1,5,6
- 1Diabetes Centre, Isala Clinics, Zwolle, the Netherlands;
- 2Langerhans Medical Research Group, Zwolle, the Netherlands;
- 3General Practice, Sleeuwijk, the Netherlands;
- 4Department of General Practice, University Medical Center Groningen, Groningen, the Netherlands;
- 5University of Groningen, Groningen, the Netherlands;
- 6Department of Internal Medicine, University Medical Center Groningen, Groningen, the Netherlands.
- Corresponding author: Susan Logtenberg, s.j.j.logtenberg{at}isala.nl.
Abstract
OBJECTIVE Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump has been available for the past 25 years. CIPII, with its specific pharmacodynamic properties, may be a viable treatment alternative to improve glycemic control in patients with type 1 diabetes for whom other therapies have failed. There have been few studies in which CIPII was compared with subcutaneous insulin treatment for patients with type 1 diabetes with poor glycemic control.
RESEARCH DESIGN AND METHODS In an open-label, prospective, crossover, randomized, 16-month study, the effects of CIPII and subcutaneous insulin were compared in 24 patients. The primary outcome measure was the incidence of hypoglycemia. Secondary outcome measures were A1C, and glucose profile, including time in euglycemia, as measured by continuous glucose monitoring.
RESULTS The incidence of grade 1 hypoglycemic events was 4.0 ± 2.6 per week with subcutaneous insulin compared with 3.5 ± 2.3 per week during CIPII (P = 0.13). The absolute mean difference in A1C with CIPII compared with subcutaneous treatment was −0.76% (95% CI −1.41 to −0.11) (P = 0.03). Baseline time spent in euglycemia was 45.2 ± 12.6% and increased 10.9% (4.6–17.3) with CIPII compared with subcutaneous treatment (absolute value; P = 0.003). There were no differences in the occurrence rate for severe hypoglycemic events, daily insulin use, or BMI. No pump or catheter malfunction was observed during the study.
CONCLUSIONS Although we did not observe a significant reduction in hypoglycemic events, improved glycemic control was achieved with the use of CIPII. We saw a 0.8% decrease in A1C and an 11% increase in the time spent in euglycemia.
Footnotes
-
↵†Deceased.
-
Clinical trial reg. no. NCT00286962, clinicaltrials.gov.
-
The sponsor had no role in the study design, data collection, analysis, interpretation, or writing of the report.
-
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
-
- Received December 31, 2008.
- Accepted April 27, 2009.
-
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.
- © 2009 by the American Diabetes Association.
