Implantable Insulin Pump vs Multiple-Dose Insulin for Non—Insulin-Dependent Diabetes Mellitus

Saudek, Christopher D.; Wc, Duckworth; Giobbie‐Hurder, Anita; Henderson, W G; Henry, Robert R.; Kelley, David E.; Edelman, Steve; Zieve, Franklin J.; Adler, Robert A.; Anderson, J W; Anderson, Robert J.; Hamilton, Bruce P.; Donner, Tom; Kirkman, M. Sue; Morgan, Nancy A.

doi:10.1001/jama.1996.03540160044031

Cited by 96 publications

(29 citation statements)

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“…Hypoglycemia was not an impediment to the subjects' achieving the treatment glycemic goals. Significantly lower rates of hypoglycemia have been reported by patients with type 2 diabetes who had implantable insulin pumps (ϳ0.6 episodes per month) compared with MDI therapy (ϳ1.8 episodes per month) (8). However, the rate of episodes by CSII subjects in this study (0.8 Ϯ 1.6 episodes per 30 days) was comparable to the rate achieved by the implantable insulin pump treatment group.…”

Section: Patient Satisfaction Questionnairecontrasting

confidence: 67%

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Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Therapy Are Equally Effective in Type 2 Diabetes

et al. 2003

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OBJECTIVE -Compare the efficacy, safety, and patient satisfaction of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy for patients with type 2 diabetes. RESEARCH DESIGN AND METHODS-A total of 132 CSII-naive type 2 diabetic patients were randomly assigned (1:1) to CSII (using insulin aspart) or MDI therapy (bolus insulin aspart and basal NPH insulin) in a multicenter, open-label, randomized, parallel-group, 24-week study. Efficacy was assessed with HbA 1c and eight-point blood glucose (BG) profiles. Treatment satisfaction was determined with a self-administered questionnaire. Safety assessments included adverse events, hypoglycemic episodes, laboratory values, and physical examination findings.RESULTS -HbA 1c values decreased similarly for both groups from baseline (8.2 Ϯ 1.37% for CSII, 8.0 Ϯ 1.08% for MDI) to end of study (7.6 Ϯ 1.22% for CSII, 7.5 Ϯ 1.22% for MDI). The CSII group showed a trend toward lower eight-point BG values at most time points (only significant 90 min after breakfast; 167 Ϯ 48 vs. 192 Ϯ 65 mg/dl for CSII and MDI, respectively; P ϭ 0.019). A total of 93% of CSII-treated subjects preferred the pump to their previous injectable insulin regimen for reasons of convenience, flexibility, ease of use, and overall preference. Safety assessments were comparable for both treatment groups.CONCLUSIONS -Insulin aspart in CSII therapy provided efficacy and safety comparable to MDI therapy for type 2 diabetes. Patients with type 2 diabetes can be trained as outpatients to use CSII and prefer CSII to injections, indicating that pump therapy should be considered when initiating intensive insulin therapy for type 2 diabetes.

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Section: Patient Satisfaction Questionnairecontrasting

confidence: 67%

“…Two studies demonstrated that CSII was as safe and effective as MDI therapy for treating type 2 diabetes (7,8). Short-term use of CSII therapy aided glycemic control in type 2 diabetic patients who failed to maintain glycemic control with diet or OADs (9,10).…”

Section: Diabetes Care 26:2598 -2603 2003mentioning

confidence: 99%

Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Therapy Are Equally Effective in Type 2 Diabetes

et al. 2003

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“…Representative event rates for severe hypoglycaemia (requiring the assistance of another person) in Type I diabetes are from 62 to 170 episodes per 100 patient years [1,10,11]. Those reported during aggressive insulin therapy of Type II diabetes range from 3 to 73 episodes per 100 patient years [10,43,44]. Thus, the rates of severe hypoglycaemia are roughly tenfold lower in Type II diabetes even during aggressive therapy with insulin.…”

Section: Pathophysiology Of Glucose Counterregulation In Type II Diabmentioning

confidence: 99%

Hypoglycaemia: The limiting factor in the glycaemic management of Type I and Type II Diabetes*

2002

Diabetologia

733

574

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Hypoglycaemia is the limiting factor in the glycaemic management of diabetes. Iatrogenic hypoglycaemia is typically the result of the interplay of insulin excess and compromised glucose counterregulation in Type I (insulin-dependent) diabetes mellitus. Insulin concentrations do not decrease and glucagon and epinephrine concentrations do not increase normally as glucose concentrations decrease. The concept of hypoglycaemia-associated autonomic failure (HAAF) in Type I diabetes posits that recent antecedent iatrogenic hypoglycaemia causes both defective glucose counterregulation (by reducing the epinephrine response in the setting of an absent glucagon response) and hypoglycaemia unawareness (by reducing the autonomic and the resulting neurogenic symptom responses). Perhaps the most compelling support for HAAF is the finding that as little as 2 to 3 weeks of scrupulous avoidance of hypoglycaemia reverses hypoglycaemia unawareness and improves the reduced epinephrine component of defective glucose counterregulation in most affected patients. The mediator and mechanism of HAAF are not known but are under active investigation. The glucagon response to hypoglycaemia is also reduced in patients approaching the insulin deficient end of the spectrum of Type II (non-insulin-dependent) diabetes mellitus, and glycaemic thresholds for autonomic (including epinephrine) and symptomatic responses to hypoglycaemia are shifted to lower plasma glucose concentrations after hypoglycaemia in Type II diabetes. Thus, patients with advanced Type II diabetes are also at risk for HAAF. While it is possible to minimise the risk of hypoglycaemia by reducing risks -including a 2 to 3 week period of scrupulous avoidance of hypoglycaemia in patients with hypoglycaemia unawareness -methods that provide glucose-regulated insulin replacement or secretion are needed to eliminate hypoglycaemia and maintain euglycaemia over a lifetime of diabetes. [Diabetologia (2002) 45:937-948] Keywords Hypoglycaemia, glucagon, epinephrine, adrenal medulla, sympathetic nervous system, hypoglycaemia-associated autonomic failure.

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“…Reduction of postmeal excursions with CSII as shown in two trials supports considering this therapy in patients for whom blood glucose spikes are likely to be particularly deleterious, e.g., those with retinal macular edema or cardiovascular lesions. A further step that may be considered for some patients remaining difficult to control with even CSII is implantable insulin pump therapy, since a randomized trial comparing implantable pump therapy versus MDI in insulin-requiring type 2 diabetic patients showed significant benefits in terms of reduced blood glucose fluctuations, mild clinical hypoglycemia, body weight improvement, and quality of life, although it was similarly effective on A1C levels (47). Hence, pump therapy might share similar indications in type 1 and type 2 diabetic patients-failure to achieve satisfactory glycemic control on MDI, usually because of elevated A1C rather than severe hypoglycemia in the case of type 2 diabetes.…”

Section: Csii As a Management Strategy In Type 2 Diabetesmentioning

confidence: 99%

Long-Acting Insulin Analogs Versus Insulin Pump Therapy for the Treatment of Type 1 and Type 2 Diabetes

Pickup

Renard

2008

Diabetes Care

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Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) is now an established form of intensive insulin treatment. It is pertinent to ask, however, if multiple daily injection (MDI) regimens based on new long-acting insulin analogs such as glargine and detemir have now replaced the need for CSII. In type 1 diabetes, CSII reduces the frequency of severe hypoglycemia compared with isophane-based MDIs, but the rate of severe hypoglycemia is usually similar on glargine-or detemir-based MDIs compared with isophane-based MDIs. CSII reduces A1C and glycemic variability compared with isophane-based MDIs; but glargine and detemir do not improve A1C or variability in many patients, particularly those who are prone to hypoglycemia. Head-to-head comparisons of CSII with MDI based on glargine indicate lower A1C, fructosamine, or glucose levels on CSII. It can be concluded that long-acting insulin analogs have not yet replaced the need for insulin pump therapy in type 1 diabetes, and CSII is the best current therapeutic option for some type 1 diabetic subjects. In type 2 diabetes, CSII and MDI produce similar glycemic control, although there is little study of MDI based on long-acting analogs compared with pumps. It is possible that CSII will be beneficial in selected patient groups with type 2 diabetes, but this requires further study. Diabetes Care 31 (Suppl. 2):S140-S145, 2008F or many decades, it has been accepted that poor glycemic control in insulin injection-treated diabetes is mainly due to the inadequacies of insulin pharmacology (1,2). Regular (shortacting) insulin is absorbed too slowly from the subcutaneous site to control postprandial hyperglycemia, and the delayed absorption then results in late hypoglycemia. Both of these problems have now been much improved by the introduction of more quickly absorbed monomeric insulins (3). The problems of longacting insulin formulations such as isophane and lente have taken longer to improve: they produce "hill-like" blood concentration and action profiles, resulting in a peak of over-insulinization in the middle of the night with a consequent risk of hypoglycemia, and a waning in insulinization before breakfast, resulting in fasting hyperglycemia (1,2,4). Moreover, these delayed-action insulin suspensions also have huge variability of subcutaneous absorption (1), contributing to much of the unpredictability in within-and between-day blood glucose control.The development of insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) nearly 30 years ago (5) did much to overcome the problems of long-acting insulin injections. The constancy of the basal delivery allows for a near-flat blood insulin profile, adjustable at preset times to suit the changing needs of the patient throughout the day. The controlled delivery of small insulin amounts substantially reduces glycemic variability (6,7). For many years, these advantages have allowed a superiority of insulin pump therapy over insulin injection regimens, at least as far as the frequency of hypoglycem...

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Implantable Insulin Pump vs Multiple-Dose Insulin for Non—Insulin-Dependent Diabetes Mellitus

Cited by 96 publications

References 0 publications

Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Therapy Are Equally Effective in Type 2 Diabetes

Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Therapy Are Equally Effective in Type 2 Diabetes

Hypoglycaemia: The limiting factor in the glycaemic management of Type I and Type II Diabetes*

Long-Acting Insulin Analogs Versus Insulin Pump Therapy for the Treatment of Type 1 and Type 2 Diabetes

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