Continuous intraperitoneal insulin infusion in type 1 diabetes: a 6-year post-trial follow-up

BMC Endocrine Disorders

Henk JG Bilo³  Nanne Kleefstra¹  Rijk OB Gans⁵  Klaas H Groenier⁴  Susan JJ Logtenberg⁵  Peter R van Dijk² 

[1] Langerhans Medical Research group, Zwolle, The Netherlands;Diabetes Centre, Isala, P.O. box 10400, 8000G.K Zwolle, The Netherlands;Isala, Department of Internal Medicine, Zwolle, The Netherlands;Department of General Practice, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

关键词: Subcutaneous insulin;    Complications;    Treatment satisfaction;    Quality of life;    Insulin infusion devices;    Intraperitoneal insulin;    Type 1 diabetes mellitus;   

Others  :  864938
DOI  :  10.1186/1472-6823-14-30

 received in 2014-03-17, accepted in 2014-04-01,  发布年份 2014

【 摘 要 】

Background

Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump is a treatment option for patients with type 1 diabetes mellitus (T1DM). Aim of the present study was to describe the long-term course of glycaemic control, complications, health related quality of life (HRQOL) and treatment satisfaction among T1DM patients treated with CIPII.

Methods

Nineteen patients that participated in a randomized cross-over trial comparing CIPII and subcutaneous (SC) therapy in 2006 were followed until 2012. Laboratory, continuous glucose monitoring, HRQOL and treatment satisfaction measurements were performed at the start of the study, the end of the SC-, the end of the CIPII treatment phase in 2006 and during CIPII therapy in 2012. Linear mixed models were used to calculate estimated values and to test differences between the moments in time.

Results

In 2012, more time was spent in hyperglycaemia than after the CIPII treatment phase in 2006: 37% (95% CI 29, 44) vs. 55% (95% CI 48, 63), mean difference 19.8% (95% CI 3.0, 36.6). HbA1c was 65 mmol/mol (95% CI 60, 71) at the end of the SC treatment phase in 2006, 58 mmol/mol (95% CI 53, 64) at the end of the CIPII treatment phase and 65 mmol/mol (95% CI 60, 71) in 2012, respectively (p > 0.05). In 2012, the median number of grade 2 hypoglycaemic events per week (1 (95% CI 0, 2)) was still significantly lower than during prior SC therapy (3 (95% CI 2, 4)): mean change -1.8 (95% CI -3.4, -0.4). Treatment satisfaction with CIPII was better than with SC insulin therapy and HRQOL remained stable. Pump or catheter dysfunction of the necessitated re-operation in 7 patients. No mortality was reported.

Conclusions

After 6 years of CIPII treatment, glycaemic regulation is stable and the number of hypoglycaemic events decreased compared to SC insulin therapy. Treatment satisfaction with CIPII is superior to SC insulin therapy, HRQOL is stable and complications are scarce. CIPII is a safe and effective treatment option for selected patients with T1DM, also on longer term.

【 授权许可】

   
2014 van Dijk et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Renard E, Schaepelynck-Bélicar P, EVADIAC Group: Implantable insulin pumps. A position statement about their clinical use. Diabetes Metab 2007, 33:158-166.
• [2]Schade DS, Eaton RP, Davis T, Akiya F, Phinney E, Kubica R, Vaughn EA, Day PW: The kinetics of peritoneal insulin absorption. Metabolism 1981, 30:149-155.
• [3]Nathan DM, Dunn FL, Bruch J, McKitrick C, Larkin M, Haggan C, Lavin-Tompkins J, Norman D, Rogers D, Simon D: Postprandial insulin profiles with implantable pump therapy may explain decreased frequency of severe hypoglycemia, compared with intensive subcutaneous regimens, in insulin-dependent diabetes mellitus patients. Am J Med 1996, 100:412-417.
• [4]Selam JL, Bergman RN, Raccah D, Jean-Didier N, Lozano J, Charles MA: Determination of portal insulin absorption from peritoneum via novel nonisotopic method. Diabetes 1990, 39:1361-1365.
• [5]Wan CK, Giacca A, Matsuhisa M, El-Bahrani B, Lam L, Rodgers C, Shi ZQ: Increased responses of glucagon and glucose production to hypoglycemia with intraperitoneal versus subcutaneous insulin treatment. Metabolism 2000, 49:984-989.
• [6]Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Gans RO, van Ballegooie E, Bilo HJ: Improved glycemic control with intraperitoneal versus subcutaneous insulin in type 1 diabetes: a randomized controlled trial. Diabetes Care 2009, 32:1372-1377.
• [7]Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Gans RO, Bilo HJ: Health-related quality of life, treatment satisfaction, and costs associated with intraperitoneal versus subcutaneous insulin administration in type 1 diabetes: a randomized controlled trial. Diabetes Care 2010, 33:1169-1172.
• [8]Haveman JW, Logtenberg SJJ, Kleefstra N, Groenier KH, Bilo HJG, Blomme AM: Surgical aspects and complications of continuous intraperitoneal insulin infusion with an implantable pump. Langenbecks Arch Surg Dtsch Ges Für Chir 2010, 395:65-71.
• [9]Van Dijk PR, Logtenberg SJJ, Groenier KH, Kleefstra N, Bilo H, Arnqvist H: Effect of intraperitoneal insulin administration on IGF1 and IGFBP1 in type 1 diabetes. Endocr Connect 2014, 3:17-23.
• [10]Ware J, Snow K, Gandek KM: SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center; 1993.
• [11]Ware JE, Kosinski M, Keller SD: SF-36 Physical and Mental Health Summary Scales: A User's Manual. Boston: The Health Institute, New England Medical Center; 1994.
• [12]World Health Organization, Regional Office for Europe: Wellbeing Measures in Primary Health Care: the Depcare Project. Report on a WHO Meeting. Stockholm: WHO Regional Office for Europe; 1998.
• [13]Bech P, Olsen LR, Kjoller M, Rasmussen NK: Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res 2003, 12:85-91.
• [14]Löwe B, Spitzer RL, Gräfe K, Kroenke K, Quenter A, Zipfel S, Buchholz C, Witte S, Herzog W: Comparative validity of three screening questionnaires for DSM-IV depressive disorders and physicians’ diagnoses. J Affect Disord 2004, 78:131-140.
• [15]Bradley C: The Diabetes Treatment Satisfaction Questionnaire: DTSQ. In Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Research and Practice. Chur: Harwood Academic Publishers; 1994:111-132.
• [16]Haardt MJ, Selam JL, Slama G, Bethoux JP, Dorange C, Mace B, Ramaniche ML, Bruzzo F: A cost-benefit comparison of intensive diabetes management with implantable pumps versus multiple subcutaneous injections in patients with type I diabetes. Diabetes Care 1994, 17:847-851.
• [17]Selam JL, Raccah D, Jean-Didier N, Lozano JL, Waxman K, Charles MA: Randomized comparison of metabolic control achieved by intraperitoneal insulin infusion with implantable pumps versus intensive subcutaneous insulin therapy in type I diabetic patients. Diabetes Care 1992, 15:53-58.
• [18]Logtenberg SJJ, van Ballegooie E, Israêl-Bultman H, van Linde A, Bilo HJG: Glycaemic control, health status and treatment satisfaction with continuous intraperitoneal insulin infusion. Neth J Med 2007, 65:65-70.
• [19]DeVries JH, Eskes SA, Snoek FJ, Pouwer F, Van Ballegooie E, Spijker AJ, Kostense PJ, Seubert M, Heine RJ: Continuous intraperitoneal insulin infusion in patients with "brittle" diabetes: favourable effects on glycaemic control and hospital stay. Diabet Med J Br Diabet Assoc 2002, 19:496-501.
• [20]Selam JL, Micossi P, Dunn FL, Nathan DM: Clinical trial of programmable implantable insulin pump for type I diabetes. Diabetes Care 1992, 15:877-885.
• [21]Schaepelynck P, Renard E, Jeandidier N, Hanaire H, Fermon C, Rudoni S, Catargi B, Riveline J-P, Guerci B, Millot L, Martin J-F, Sola A, EVADIAC Group: A recent survey confirms the efficacy and the safety of implanted insulin pumps during long-term use in poorly controlled type 1 diabetes patients. Diabetes Technol Ther 2011, 13:657-660.
• [22]Catargi B, Meyer L, Melki V, Renard E, Jeandidier N, EVADIAC Study Group: Comparison of blood glucose stability and HbA1C between implantable insulin pumps using U400 HOE 21PH insulin and external pumps using lispro in type 1 diabetic patients: a pilot study. Diabetes Metab 2002, 28:133-137.
• [23]Gin H, Renard E, Melki V, Boivin S, Schaepelynck-Bélicar P, Guerci B, Selam JL, Brun JM, Riveline JP, Estour B, Catargi B, EVADIAC Study Group: Combined improvements in implantable pump technology and insulin stability allow safe and effective long term intraperitoneal insulin delivery in type 1 diabetic patients: the EVADIAC experience. Diabetes Metab 2003, 29:602-607.
• [24]Hanaire-Broutin H, Broussolle C, Jeandidier N, Renard E, Guerci B, Haardt MJ, Lassmann-Vague V: Feasibility of intraperitoneal insulin therapy with programmable implantable pumps in IDDM. A multicenter study. The EVADIAC Study Group. Evaluation dans le Diabète du Traitement par Implants Actifs. Diabetes Care 1995, 18:388-392.
• [25]Broussolle C, Jeandidier N, Hanaire-Broutin H: French multicentre experience of implantable insulin pumps. The EVADIAC Study Group. Evaluation of Active Implants in Diabetes Society. Lancet 1994, 343:514-515.
• [26]Oskarsson PR, Lins PE, Backman L, Adamson UC: Continuous intraperitoneal insulin infusion partly restores the glucagon response to hypoglycaemia in type 1 diabetic patients. Diabetes Metab 2000, 26:118-124.
• [27]McHorney CA, Ware JE Jr, Raczek AE: The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993, 31:247-263.