MEDLINE Abstract Collection
MEDLINE Abstract Collection
What's new in insulin pump therapy? Find out in this easy-to-navigate collection of recent MEDLINE abstracts compiled by the editors at Medscape Diabetes and Endocrinology.
Litton J, Rice A, Friedman N, Oden J, Lee MM, Freemark M
J Pediatr. 2002;141:490-495
Objective: To test whether glycemic control in young children could be achieved more effectively and safely by using continuous insulin infusions administered by insulin pumps.
Study Design: We analyzed the effects of pump therapy in nine toddlers in whom type 1 diabetes developed between the ages of 10 and 40 months. After a mean of 13.7 months of therapy with multiple daily injections, patients were treated with insulin pumps for periods ranging from 7 to 19 months (mean, 12.7 months).
Results: Before initiation of pump therapy, HbA1c levels averaged 9.5% +/- 0.4%, and patients had a mean of 0.52 episodes per month of severe hypoglycemia (uncontrolled shaking, inconsolable crying, disorientation, or seizures). After initiation of pump therapy, HbA1c levels declined to 7.9% +/- 0.3% (P <.001 vs prepump levels), and the incidence of severe hypoglycemia decreased to 0.09 episodes per month (P <.05). Normal linear growth and weight gain were maintained during pump therapy. There were no changes in the frequency of physician or emergency room visits for acute hyperglycemia or ketoacidosis. However, the frequency of parental contacts with health personnel declined by >80%, reflecting increasing parental confidence and independence in diabetic care. Subjective assessments revealed significant improvements in quality of life and high levels of satisfaction with pump therapy.
Conclusions: Insulin pump therapy may provide an effective alternative for selected preschool children with type 1 diabetes.
Catargi B, Meyer L, Melki V, Renard E, Jeandidier N; for the EVADIAC Study Group
Diabetes Metab. 2002;28:133-137
Background: To assess the efficacy on blood glucose control of continuous peritoneal insulin infusion from implantable pump (CPII) compared with continuous subcutaneous infusion using insulin lispro (CSII-IL) in type 1 diabetic patients.
Methods: Fourteen type 1 diabetic patients (5 males and 9 women, age 50.6 +/- 12.8, diabetes duration 28.0 +/- 13.4 years) were treated with CSII-IL and CPII. Capillary blood glucose (BG) was monitored and recorded at least 4 times per day during 2 study periods of 45 days: using CSII-IL (period A), and from 45th to 90th day after implantation (period B). HbA1C was measured at the end of each period.
Results: Both daily BG levels (145 +/- 18 vs 153 +/- 17 mg/dl, p<0.01) and preprandial BG levels (139 +/- 20 vs 147 +/- 22 mg/dl, p<0.05) were lower in period B. Although postprandial BG values tended to be lower in period B, this reduction did not reach statistical significance (149 +/- 20 vs 157 +/- 16 mg/dl, p=0.07). Meanwhile, SD of all BG values was lower with CPII (69 +/- 11 vs 79 +/- 17 mg/dl, p<0.01) and HbA1c levels were lower at the end of period B (7.3 +/- 0.9 vs 7.8 +/- 0.9%, p=0.04). Low blood glucose index was comparable during both periods (2.8 +/- 1.6 vs 3.1 +/- 1.5, p=0.4).
Conclusion: CPII may provide a better BG control and stability than CSII-IL. However, a long-term randomized prospective study is needed to confirm these improvements.
Pickup J, Keen H
Diabetes Care. 2002;25:593-598
Continuous subcutaneous insulin infusion (CSII) is used in selected type 1 diabetic subjects to achieve strict blood glucose control. A quarter of a century after its introduction, world-wide use of CSII is increasing. We review the evidence base that justifies this increase, including effectiveness compared with modern intensified insulin injection regimens and concern about possible complications. Review of controlled trials shows that, in most patients, mean blood glucose concentrations and glycated hemoglobin percentages are either slightly lower or similar on CSII versus multiple insulin injections. However, hypoglycemia is markedly less frequent than during intensive injection therapy. Ketoacidosis occurs at the same rate. Nocturnal glycemic control is improved with insulin pumps, and automatic basal rate changes help to minimize a prebreakfast blood glucose increase (the "dawn phenomenon") often seen with injection therapy. Patients with "brittle" diabetes characterized by recurrent ketoacidosis are often not improved by CSII, although there may be exceptions. We argue that explicit clinical indications for CSII are helpful; we suggest the principal indications for health service or health insurance-funded CSII should include frequent, unpredictable hypoglycemia or a marked dawn phenomenon, which persist after attempts to improve control with intensive insulin injection regimens. In any circumstances, candidates for CSII must be motivated, willing and able to undertake pump therapy, and adequately psychologically stable. Some diabetic patients with well-defined clinical problems are likely to benefit substantially from CSII and should not be denied a trial of the treatment. Their number is relatively small, as would therefore be the demand on funds set aside for this purpose.
Renard E, Costalat G, Bringer J
Diabetes Metab. 2002;28(4 Pt 2):19-25
The project to finalize a 'closed loop' insulin delivery according to blood glucose level, i.e. an implanted artificial beta cell, is born from the development of the first miniaturized portable insulin pumps during the 1970s. Continuous improvements in micro-electronics, as well as in the development of biomaterials and stable insulin solutions, have led to the availability of implantable pumps able to infuse insulin by the peritoneal route, in a continuous and programmable way, for several years. These systems represent the most efficient and physiological mode of insulin therapy at the present time. More recently, we have demonstrated during clinical trials that intravascular, implantable, glucose sensors using glucose-oxidase were able to measure with good accuracy real-time blood glucose for several months. The combination of these two devices to form a prototype of implantable artificial beta cell, designated as Long Term Sensor System, allowed us to perform the first trials of closed-loop insulin delivery according to sensor signal for periods of 48 hours in type 1 diabetic patients. This mode of functioning appeared to be feasible and able to establish glucose control closer to physiology than the use of implantable pumps in open-loop, i.e. by adapting insulin delivery according to capillary blood glucose. Although algorithms tuning automated insulin delivery are improvable, the success of these initial trials materializes the perspective of a possible restoration of physiological insulin function by the mean of an implanted artificial beta cell in diabetic patients.
Selam JL
Exp Clin Endocrinol Diab. 2001;109(Suppl 2):S333-S340
External insulin infusion (CSII) pumps have regained interest since DCCT, the number of patients approaching 100,000 in the USA. Only 2 manufacturers (Minimed, Disetronic) and 2 insulins (lispro, insuman) are sharing the market. The major advantages over multiple SC injections (MDI) are a reduction of nightly instability and hypoglycemia, and time flexibility. Patients poorly controlled under MDI and/or with recurrent hypoglycemias thus represent the best indications. Pumps are predicted to expand in some European countries e. g. France with changes in reimbursement regulations. Implantable insulin pumps are still not commercialized except in few countries e. g. France. Therefore only 1065 pumps have been implanted worldwide so far. The only material available is the Minimed 2007 pump, with the Aventis Genapol insulin. The catheter is intraperitoneal for portal insulin absorption. Metabolic results are better than CSII in terms of glycemic fluctuations and hypoglycemias. Adverse events are limited to catheter obstructions (15% per patient-year). Ideally, indications should be restricted only to patients with recurrent severe hypoglycemias and/or poor control with CSII because of high cost of the pump ($15,000).
Simmons D, Thompson CF, Conroy C, Scott DJ
Diabetes Care. 2001;24:2078-2082
Objective: To describe the use of insulin pump therapy in women with gestational diabetes mellitus (GDM) or type 2 diabetes in pregnancy and persistent hyperglycemia despite multiple injections of subcutaneous insulin.
Research Design and Methods: As part of a service audit, deliveries to women with diabetes at a single South Auckland hospital were reviewed from 1991 through 1994. Glycemic control was estimated by the mean of self-recorded and laboratory postprandial glucose concentrations. In a nested case-control study, pregnancies complicated by GDM/type 2 diabetes with use of an insulin pump were compared with those without insulin pump therapy and peak insulin requirements of 100-199 units/ day, matched for ethnicity and type of diabetes.
Results: A total of 30 of 251 Polynesian, European, and South Asian women with singleton pregnancies complicated by insulin-requiring GDM/type 2 diabetes used an insulin pump. An additional two women with high insulin requirements discontinued pump therapy. None of the women with GDM/type 2 diabetes experienced severe hypoglycemia, whereas 79% of the women had improved glycemic control within 1-4 weeks. Mothers using a pump had greater insulin requirements (median maximum 246 vs. 130 units per day) and greater weight gain (10.6 vs. 5.0 kg). Their babies were more likely to be admitted to the Special Care Baby Unit but were neither significantly heavier nor experienced greater hypoglycemia than control subjects.
Conclusions: Insulin pump therapy seems to be safe and effective for maintaining glycemic control in pregnancies complicated by GDM/type 2 diabetes and requiring large doses of insulin.
Tamborlane WV, Bonfig W, Boland E.
Diabet Med. 2001;18):864-870
While treatment of Type 1 diabetes mellitus (T1DM) in children and adolescents is especially difficult, recent technological advances have provided new therapeutic options to clinicians and patients. The urgency to achieve strict diabetes control and the introduction of new and improved insulin pumps have been accompanied by a marked increase in use of continuous subcutaneous insulin infusion (CSII) therapy in youth with diabetes. Results of clinical outcome studies indicate that CSII provides a safe and effective alternative to multiple daily injection (MDI) therapy, even when employed in a regular clinic setting in a large number of children. The safety and efficacy of CSII is further enhanced by the introduction of lispro and aspart insulin. The sharper peaks and shorter duration of action of these very rapid-acting insulin analogues provides a means to achieve better control of post-prandial hyperglycaemia with less late post-prandial and nocturnal hypoglycaemia. Glargine insulin, a soluble and essentially peakless long-acting insulin analogue, may provide a better basal insulin for MDI regimens, but there are limited published data with this agent in children with T1DM. A number of systems for pulmonary delivery of insulin are in development and preliminary results of Phase III studies have been promising. Like CSII, inhaled insulin allows the child to take bolus insulin doses before each meal without having to take a premeal injection. A major obstacle to effective treatment is that self-monitoring of three to four blood glucose levels a day often misses the marked glycaemic excursions that characterize T1DM in young patients. On the other hand, new continuous glucose sensing systems provide a wealth of data that can be used to optimize basal and bolus therapy, regardless of how insulin is administered. Even more important, we may finally be at the threshold of development of a practically applicable artificial pancreas.
Catargi B, Breilh D, Gin H, Rigalleau V, Saux MC, Roger P, Tabarin A
Diabetes Metab. 2001;27:323-327
Objective: To compare a non-programmable and a programmable insulin external pump using regular insulin on glycemic stability, the risk of severe hypoglycemia and metabolic control in type 1 diabetic patients.
Materials and Methods: Ten type 1 diabetic patients were involved in a randomized, crossover study comparing two periods of 3 months with continuous subcutaneous insulin infusion (CSII) either with a non-programmable insulin pump or a programmable insulin pump. Comparisons were made among mean blood glucose values before and after meals, at bedtime and at 2: 00 a.m.; the risk of severe hypoglycemia assessed by the low blood glucose index (LBGI); and HbA1c.
Results: Mean average blood glucose (BG) measurements were significantly lower with the programmable in comparison with the non-programmable insulin pump (respectively 157+/-78 vs. 165+/-79, p=0.034). While postprandial values for BG were not different between the two pumps, the use of the programmable pump resulted in a significant decrease in mean preprandial BG levels (140+/-68 vs. 150+/-73 mg/dl p=0.039). Conversely mean BG level was lower at 2 a.m. with the non-programmable pump (125+/-81 vs. 134 +/-93 mg/dl, p=0.02) but with a higher incidence of hypoglycemia. Mean LBGI was comparable with the two pumps (3.1+/-8.6 vs. 2.8+/-6.9, p=0.1). There was a 0.2% decrease in HbA1c during the programmable pump period that did not reach statistical significance (p=0.37).
Conclusions: The present study suggests that programmable external insulin pumps, although more complex and more expensive than non-programmable insulin pumps, significantly reduce fasting glycemia during the day without increasing the risk of severe hypoglycemia and are safer during the night.
What's new in insulin pump therapy? Find out in this easy-to-navigate collection of recent MEDLINE abstracts compiled by the editors at Medscape Diabetes and Endocrinology.
Litton J, Rice A, Friedman N, Oden J, Lee MM, Freemark M
J Pediatr. 2002;141:490-495
Objective: To test whether glycemic control in young children could be achieved more effectively and safely by using continuous insulin infusions administered by insulin pumps.
Study Design: We analyzed the effects of pump therapy in nine toddlers in whom type 1 diabetes developed between the ages of 10 and 40 months. After a mean of 13.7 months of therapy with multiple daily injections, patients were treated with insulin pumps for periods ranging from 7 to 19 months (mean, 12.7 months).
Results: Before initiation of pump therapy, HbA1c levels averaged 9.5% +/- 0.4%, and patients had a mean of 0.52 episodes per month of severe hypoglycemia (uncontrolled shaking, inconsolable crying, disorientation, or seizures). After initiation of pump therapy, HbA1c levels declined to 7.9% +/- 0.3% (P <.001 vs prepump levels), and the incidence of severe hypoglycemia decreased to 0.09 episodes per month (P <.05). Normal linear growth and weight gain were maintained during pump therapy. There were no changes in the frequency of physician or emergency room visits for acute hyperglycemia or ketoacidosis. However, the frequency of parental contacts with health personnel declined by >80%, reflecting increasing parental confidence and independence in diabetic care. Subjective assessments revealed significant improvements in quality of life and high levels of satisfaction with pump therapy.
Conclusions: Insulin pump therapy may provide an effective alternative for selected preschool children with type 1 diabetes.
Catargi B, Meyer L, Melki V, Renard E, Jeandidier N; for the EVADIAC Study Group
Diabetes Metab. 2002;28:133-137
Background: To assess the efficacy on blood glucose control of continuous peritoneal insulin infusion from implantable pump (CPII) compared with continuous subcutaneous infusion using insulin lispro (CSII-IL) in type 1 diabetic patients.
Methods: Fourteen type 1 diabetic patients (5 males and 9 women, age 50.6 +/- 12.8, diabetes duration 28.0 +/- 13.4 years) were treated with CSII-IL and CPII. Capillary blood glucose (BG) was monitored and recorded at least 4 times per day during 2 study periods of 45 days: using CSII-IL (period A), and from 45th to 90th day after implantation (period B). HbA1C was measured at the end of each period.
Results: Both daily BG levels (145 +/- 18 vs 153 +/- 17 mg/dl, p<0.01) and preprandial BG levels (139 +/- 20 vs 147 +/- 22 mg/dl, p<0.05) were lower in period B. Although postprandial BG values tended to be lower in period B, this reduction did not reach statistical significance (149 +/- 20 vs 157 +/- 16 mg/dl, p=0.07). Meanwhile, SD of all BG values was lower with CPII (69 +/- 11 vs 79 +/- 17 mg/dl, p<0.01) and HbA1c levels were lower at the end of period B (7.3 +/- 0.9 vs 7.8 +/- 0.9%, p=0.04). Low blood glucose index was comparable during both periods (2.8 +/- 1.6 vs 3.1 +/- 1.5, p=0.4).
Conclusion: CPII may provide a better BG control and stability than CSII-IL. However, a long-term randomized prospective study is needed to confirm these improvements.
Pickup J, Keen H
Diabetes Care. 2002;25:593-598
Continuous subcutaneous insulin infusion (CSII) is used in selected type 1 diabetic subjects to achieve strict blood glucose control. A quarter of a century after its introduction, world-wide use of CSII is increasing. We review the evidence base that justifies this increase, including effectiveness compared with modern intensified insulin injection regimens and concern about possible complications. Review of controlled trials shows that, in most patients, mean blood glucose concentrations and glycated hemoglobin percentages are either slightly lower or similar on CSII versus multiple insulin injections. However, hypoglycemia is markedly less frequent than during intensive injection therapy. Ketoacidosis occurs at the same rate. Nocturnal glycemic control is improved with insulin pumps, and automatic basal rate changes help to minimize a prebreakfast blood glucose increase (the "dawn phenomenon") often seen with injection therapy. Patients with "brittle" diabetes characterized by recurrent ketoacidosis are often not improved by CSII, although there may be exceptions. We argue that explicit clinical indications for CSII are helpful; we suggest the principal indications for health service or health insurance-funded CSII should include frequent, unpredictable hypoglycemia or a marked dawn phenomenon, which persist after attempts to improve control with intensive insulin injection regimens. In any circumstances, candidates for CSII must be motivated, willing and able to undertake pump therapy, and adequately psychologically stable. Some diabetic patients with well-defined clinical problems are likely to benefit substantially from CSII and should not be denied a trial of the treatment. Their number is relatively small, as would therefore be the demand on funds set aside for this purpose.
Renard E, Costalat G, Bringer J
Diabetes Metab. 2002;28(4 Pt 2):19-25
The project to finalize a 'closed loop' insulin delivery according to blood glucose level, i.e. an implanted artificial beta cell, is born from the development of the first miniaturized portable insulin pumps during the 1970s. Continuous improvements in micro-electronics, as well as in the development of biomaterials and stable insulin solutions, have led to the availability of implantable pumps able to infuse insulin by the peritoneal route, in a continuous and programmable way, for several years. These systems represent the most efficient and physiological mode of insulin therapy at the present time. More recently, we have demonstrated during clinical trials that intravascular, implantable, glucose sensors using glucose-oxidase were able to measure with good accuracy real-time blood glucose for several months. The combination of these two devices to form a prototype of implantable artificial beta cell, designated as Long Term Sensor System, allowed us to perform the first trials of closed-loop insulin delivery according to sensor signal for periods of 48 hours in type 1 diabetic patients. This mode of functioning appeared to be feasible and able to establish glucose control closer to physiology than the use of implantable pumps in open-loop, i.e. by adapting insulin delivery according to capillary blood glucose. Although algorithms tuning automated insulin delivery are improvable, the success of these initial trials materializes the perspective of a possible restoration of physiological insulin function by the mean of an implanted artificial beta cell in diabetic patients.
Selam JL
Exp Clin Endocrinol Diab. 2001;109(Suppl 2):S333-S340
External insulin infusion (CSII) pumps have regained interest since DCCT, the number of patients approaching 100,000 in the USA. Only 2 manufacturers (Minimed, Disetronic) and 2 insulins (lispro, insuman) are sharing the market. The major advantages over multiple SC injections (MDI) are a reduction of nightly instability and hypoglycemia, and time flexibility. Patients poorly controlled under MDI and/or with recurrent hypoglycemias thus represent the best indications. Pumps are predicted to expand in some European countries e. g. France with changes in reimbursement regulations. Implantable insulin pumps are still not commercialized except in few countries e. g. France. Therefore only 1065 pumps have been implanted worldwide so far. The only material available is the Minimed 2007 pump, with the Aventis Genapol insulin. The catheter is intraperitoneal for portal insulin absorption. Metabolic results are better than CSII in terms of glycemic fluctuations and hypoglycemias. Adverse events are limited to catheter obstructions (15% per patient-year). Ideally, indications should be restricted only to patients with recurrent severe hypoglycemias and/or poor control with CSII because of high cost of the pump ($15,000).
Simmons D, Thompson CF, Conroy C, Scott DJ
Diabetes Care. 2001;24:2078-2082
Objective: To describe the use of insulin pump therapy in women with gestational diabetes mellitus (GDM) or type 2 diabetes in pregnancy and persistent hyperglycemia despite multiple injections of subcutaneous insulin.
Research Design and Methods: As part of a service audit, deliveries to women with diabetes at a single South Auckland hospital were reviewed from 1991 through 1994. Glycemic control was estimated by the mean of self-recorded and laboratory postprandial glucose concentrations. In a nested case-control study, pregnancies complicated by GDM/type 2 diabetes with use of an insulin pump were compared with those without insulin pump therapy and peak insulin requirements of 100-199 units/ day, matched for ethnicity and type of diabetes.
Results: A total of 30 of 251 Polynesian, European, and South Asian women with singleton pregnancies complicated by insulin-requiring GDM/type 2 diabetes used an insulin pump. An additional two women with high insulin requirements discontinued pump therapy. None of the women with GDM/type 2 diabetes experienced severe hypoglycemia, whereas 79% of the women had improved glycemic control within 1-4 weeks. Mothers using a pump had greater insulin requirements (median maximum 246 vs. 130 units per day) and greater weight gain (10.6 vs. 5.0 kg). Their babies were more likely to be admitted to the Special Care Baby Unit but were neither significantly heavier nor experienced greater hypoglycemia than control subjects.
Conclusions: Insulin pump therapy seems to be safe and effective for maintaining glycemic control in pregnancies complicated by GDM/type 2 diabetes and requiring large doses of insulin.
Tamborlane WV, Bonfig W, Boland E.
Diabet Med. 2001;18):864-870
While treatment of Type 1 diabetes mellitus (T1DM) in children and adolescents is especially difficult, recent technological advances have provided new therapeutic options to clinicians and patients. The urgency to achieve strict diabetes control and the introduction of new and improved insulin pumps have been accompanied by a marked increase in use of continuous subcutaneous insulin infusion (CSII) therapy in youth with diabetes. Results of clinical outcome studies indicate that CSII provides a safe and effective alternative to multiple daily injection (MDI) therapy, even when employed in a regular clinic setting in a large number of children. The safety and efficacy of CSII is further enhanced by the introduction of lispro and aspart insulin. The sharper peaks and shorter duration of action of these very rapid-acting insulin analogues provides a means to achieve better control of post-prandial hyperglycaemia with less late post-prandial and nocturnal hypoglycaemia. Glargine insulin, a soluble and essentially peakless long-acting insulin analogue, may provide a better basal insulin for MDI regimens, but there are limited published data with this agent in children with T1DM. A number of systems for pulmonary delivery of insulin are in development and preliminary results of Phase III studies have been promising. Like CSII, inhaled insulin allows the child to take bolus insulin doses before each meal without having to take a premeal injection. A major obstacle to effective treatment is that self-monitoring of three to four blood glucose levels a day often misses the marked glycaemic excursions that characterize T1DM in young patients. On the other hand, new continuous glucose sensing systems provide a wealth of data that can be used to optimize basal and bolus therapy, regardless of how insulin is administered. Even more important, we may finally be at the threshold of development of a practically applicable artificial pancreas.
Catargi B, Breilh D, Gin H, Rigalleau V, Saux MC, Roger P, Tabarin A
Diabetes Metab. 2001;27:323-327
Objective: To compare a non-programmable and a programmable insulin external pump using regular insulin on glycemic stability, the risk of severe hypoglycemia and metabolic control in type 1 diabetic patients.
Materials and Methods: Ten type 1 diabetic patients were involved in a randomized, crossover study comparing two periods of 3 months with continuous subcutaneous insulin infusion (CSII) either with a non-programmable insulin pump or a programmable insulin pump. Comparisons were made among mean blood glucose values before and after meals, at bedtime and at 2: 00 a.m.; the risk of severe hypoglycemia assessed by the low blood glucose index (LBGI); and HbA1c.
Results: Mean average blood glucose (BG) measurements were significantly lower with the programmable in comparison with the non-programmable insulin pump (respectively 157+/-78 vs. 165+/-79, p=0.034). While postprandial values for BG were not different between the two pumps, the use of the programmable pump resulted in a significant decrease in mean preprandial BG levels (140+/-68 vs. 150+/-73 mg/dl p=0.039). Conversely mean BG level was lower at 2 a.m. with the non-programmable pump (125+/-81 vs. 134 +/-93 mg/dl, p=0.02) but with a higher incidence of hypoglycemia. Mean LBGI was comparable with the two pumps (3.1+/-8.6 vs. 2.8+/-6.9, p=0.1). There was a 0.2% decrease in HbA1c during the programmable pump period that did not reach statistical significance (p=0.37).
Conclusions: The present study suggests that programmable external insulin pumps, although more complex and more expensive than non-programmable insulin pumps, significantly reduce fasting glycemia during the day without increasing the risk of severe hypoglycemia and are safer during the night.