[Diabetes mellitus. 13. Insulin therapy of diabetes mellitus].
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[A structured treatment and educational program for patients with type 2 diabetes mellitus, insulin therapy and impaired cognitive function (DikoL)].
BACKGROUND AND PURPOSE: More than 50% of patients with type-2 diabetes mellitus and impaired cognitive function are overtaxed with some topics of established structured treatment and teaching programs for patients with insulin therapy. This leads to substantial deficits in respect of the patients' ability of diabetes self-management (insulin injections, self-monitoring) and the need for help by relatives and social workers. The consequences are an impaired quality of life and a great deal of expense in the welfare system. Since 1996, a specialized structured treatment and teaching program for patients with type-2 diabetes mellitus, insulin therapy, and impaired cognitive function (DikoL) has been developed. Main differences in comparison to established programs were less theoretical topics (no pathophysiology, no insulin action, no complicated calculation of carbohydrate pounds) and more time for practical exercise. In a randomized prospective study, the effectiveness of the DikoL program was evaluated. PATIENTS AND METHODS: All patients with type-2 diabetes mellitus (n = 106, age 68.6 +/- 8.7 years, median diabetes duration 10.3 [0.03-35.4] years, HbAlC 10.3+ 1.7% [HPLC, Diamat, normal range 4.5-6.3%], cognitive function 87.7 +12.3 IQ points), admitted to hospital to participate in a structured treatment and teaching program between April 1999 and June 2000, were studied. Patients with impaired cognitive function (< 91 IQ points) were randomized: they participated either in an established structured treatment and teaching program according to Berger et al. (standard group: n = 35) or in the DikoL program(DikoL group: n = 33). Immediately after participation and 0.5 years later, the quality of diabetes control, patients' knowledge of diabetes, their ability for diabetes self-management, and their satisfaction with the program were evaluated. RESULTS: Patients of the DikoL group had a comparable quality of diabetes control (HbAlc: DikoL vs. standard group: 8.5 + 1.3 vs. 8.3 +/- 1.4%; p = 0.62)and diabetes-related knowledge (DikoL vs. standard group: 9.6 +/- 4.4 vs.10.3 + 3.8 points; p = 0.52), but significantly better results in respect of their ability for diabetes self-management (DikoL vs. standard group: 15.9 +/- 3.1 vs. 12.5 +/- 4.1 points; p = 0.001) than patients of the standard group. Moreover, in the DikoL group there was a tendency to a lower number of patients needing third-party assistance (n = 1 patient of the DikoL group vs. n = 5 patients of the standard group; p = 0.13). There were no acute complications (hypoglycemia, comata, and foot ulcers) in neither group. Following participation in the DikoL program, patients reached a better score in the questionnaire evaluating satisfaction with the treatment and teaching program (DikoL vs. standard group:52.5 + 4.5 vs. 44.7 + 76 points; p < 0,001). CONCLUSION: Following the wishes of the majority of diabetes educators as well as diabetologists but also patients' wishes, a specially designed structured treatment and teaching program for patients with type-2 diabetes mellitus, insulin therapy, and impaired cognitive function was designed. DikoL is the first program evaluated in a randomized, prospective trial. It clearly demonstrated a bet-ter outcome for patients with impaired cognitive function in respect of diabetes self-management and satisfaction. With its implementation, patients' quality of diabetes care can be improved in a substantial manner.
Aged↗
Insulin analogues: new therapies for type 2 diabetes mellitus.
Insulin therapy is ultimately necessary for the control of blood glucose in a majority of patients with type 2 diabetes mellitus. Unfortunately, the pharmacokinetic characteristics of previously available rapid-, intermediate-, and long-acting preparations make sustained normoglycemia almost impossible. Advances in molecular genetic engineering have made possible the development of insulin analogues with pharmacokinetics that more closely mimic the needs of patients with type 2 diabetes. In the following article, we explore the insulin analogues currently available for clinical use, their pharmacokinetics, and the rationale for their use in the treatment of type 2 diabetes, and follow-up with a brief examination of future developments.
Administration, Inhalation↗
[Insulin therapy in elderly patients with diabetes mellitus].
Insulin therapy is an effective measure of improving glucose control even in elderly patients with type 2 diabetes. However, it is controversial whether insulin therapy does disturb the quality of life (QOL) as well as cognitive function in the elderly. In our previous study of 455 diabetic patients, the well-being as assessed by the morale scale was similar in three treatment groups. In contrast, the symptom-burden, social burden, and worry about diabetes as assessed by the Elderly Diabetes Burden Scales was more increased in insulin-treated group as compared to the diet-treated group after adjustment for age, gender, HbAlc, frequency of hypoglycemia, microangiopathy, macroangiopathy, and social support. In another study of 213 patients, MMSE scores were similar among treatment groups, while attention and learning were most impaired in insulin-treated groups after adjustment for age, gender, HbAlc, and duration of diabetes. Although the mechanism for the association between insulin treatment and cognitive impairment is unknown, hyperglycemia, hypoglycemia, and cerebral complications in insulin-treated patients may be possible explanations. Whatever mechanism may be involved, hypoglycemia should be considered especially if unexpectedly low HbAlc (< 6.5%) is observed or atypical neuropsychological symptoms appear. It is unknown how insulin withdrawal is successful in elderly diabetic patients. Using rapid or ultrarapid insulin injections three times daily, good glucose control achieved the goal of plasma glucose level of < 140 mg/dl before meals and at bedtime. Then, insulin therapy was converted to oral treatment of glimepiride (2 to 6 mg/day) and/or voglibose (0.6 mg/day) in 30 patients with poorly controlled Type 2 diabetes. About 83% of the patients were successful in the insulin withdrawal according to the criteria of HbAlc levels after two months < 8.0%. After removal of glucose toxicity, insulin withdrawal should be attempted to improve QOL in elderly patients with diabetes mellitus.
Aged↗
Current perspective in insulin therapy in the management of diabetes mellitus.
Insulin therapy since its discovery in 1922 is effective in restoring normoglycaemia, suppressing ketogenesis, delaying or arresting diabetic complications. The commonest indication for regular insulin therapy in type-2 diabetes is oral hypoglycaemic agent (OHA) failure. Regular insulin therapy is also indicated in patients of diabetes associated with renal or hepatic disease where OHA is contra-indicated. Different types and species of insulin have different pharmacological properties. There are several methods of insulin administration. Efficacy of human insulin has been proved beyond doubt. However, there is no reason to believe that animal insulin is inferior to human insulin.
Administration, Oral↗
[Progress in insulin therapy of diabetes mellitus with special reference to DI-insulin and NPH-insulin].
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Diabetes Mellitus↗
Modern insulin therapy for type 1 diabetes mellitus.
Modern insulin therapy for Type 1 diabetes is part of a comprehensive treatment program designed to achieve and maintain blood glucose levels as close to normal as possible. The insulin regimens most likely to be successful approximate physiologic insulin delivery by combining basal and meal doses. Several options are available, including constant infusion by external pump and multiple daily injection therapy. Modern therapy affords major health benefits through improved blood glucose control, as well as lifestyle benefits associated with increased flexibility and spontaneity.
Blood Glucose↗
Continuous basal insulin infusion without premeal boluses in insulin-dependent diabetes mellitus therapy.
Six insulin-dependent diabetic patients, poorly controlled on conventional insulin therapy (CIT), underwent continuous basal insulin infusion (CBII) and continuous subcutaneous insulin infusion (CSII) during 2 subsequent periods of 1 month each, employing a Betatron II insulin infusion pump (Lilly, CPI). During CSII, insulin was infused at a continuous basal rate with 3 premeal boluses. During CBII, from 22(00) to 06(00) a continuous basal nocturnal insulin infusion rate and from 06(00) to 22(00) a diurnal one, which was approximately twice the former, were maintained and total daily calorie intake was subdivided into 6 isoglycidic and isocaloric meals, taken at regular intervals. We obtained better blood glucose control both by CSII and CBII than by CIT, with significant reduction of HbA1 values. Mean blood glucose levels were lower during CBII than during CSII, while M-index, number of hypo- and hyperglycemic events and insulin requirement were not different. However, daily blood glucose excursions were narrower and percent blood glucose increment after the noon meal was reduced during CBII. CBII insulin profile was characterized by a plateau trend with lower levels at meals in comparison with CSII. Our data show that the subdivision of daily calorie intake into 6 isocaloric and isoglycidic meals allows to achieve good metabolic control by continuous basal insulin infusion without need for premeal boluses and could be especially useful in brittle diabetic patients, whose brittle condition may be caused by erratic absorption of subcutaneous boluses of insulin.
Adult↗
Outpatient initiation of insulin therapy in patients with diabetes mellitus.
Before insulin therapy is begun, patients with diabetes are often admitted to hospital. In a retrospective study we have reviewed the initiation of insulin therapy in 54 unselected outpatients (12 of whom were insulin-dependent), when the initial stabilization of therapy was performed predominantly by nurse educators. Most patients found the procedure satisfactory; only one subject indicated dissatisfaction with the regimen and only two indicated that they would have preferred admission to hospital. No patient experienced an acute hypoglycaemic or hyperglycaemic problem that required admission to hospital nor was emergency intervention required during the 12 months that followed the initial stabilization period of insulin therapy. Metabolic control, as measured by glycosylated haemoglobin levels, improved in the majority of both insulin-dependent and non-insulin-dependent patients after 12 months of insulin therapy. A retrospective cost analysis that compared the cost of the outpatient procedure with the cost (hospital-bed costs only) of initiating insulin therapy in a similar group of patients who were admitted to hospital, indicated a saving of $1857 for each outpatient. We conclude that the outpatient initiation of insulin therapy is feasible where the facilities for education about diabetes exist, that it is safe, achieves satisfactory metabolic control, is acceptable to most patients, and offers a considerable saving in costs.
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Rapid improvement in insulin binding to erythrocyte insulin receptors in non-insulin-dependent diabetes mellitus during therapy.
Insulin binding to erythrocyte receptors was studied in 36 newly diagnosed male subjects with NIDDM, treated with diet alone (Group I; n = 10) or diet + glibenclamide (Group II; n = 12) or diet + glibenclamide + metformin (Group III; n = 14). Fourteen matched non-diabetic subjects were also studied as controls. Initially, mean (+/- SD) specific insulin binding was lower in NIDDM patients than in controls (p less than 0.001), due to decreased receptor number and affinity. Control of diabetes with short-term therapy (10 +/- 2 days) resulted in significantly increased specific insulin binding in Groups II and III (p less than 0.001). A marginal increase was observed in Group I (p less than 0.01). The improved insulin binding observed in Group II and III patients after short-term therapy was maintained even after long-term therapy (9 +/- 1 months). Analysis of the insulin binding data by Scatchard plots and average affinity profiles indicated increased receptor number and affinity after short-term therapy. However, changes in affinity were reversed with long-term therapy in Groups II and III and the predominant effect appeared to be an increase in the number of binding sites.
Adult↗
Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy.
BACKGROUND: The fetuses of women with gestational diabetes mellitus are at risk for macrosomia and its attendant complications. The best method of achieving euglycemia in these women and reducing morbidity in their infants is not known. We compared the efficacy of postprandial and preprandial monitoring in achieving glycemic control in women with gestational diabetes. METHODS: We studied 66 women with gestational diabetes mellitus who required insulin therapy at 30 weeks of gestation or earlier. The women were randomly assigned to have their diabetes managed according to the results of preprandial monitoring or postprandial monitoring (one hour after meals) of blood glucose concentrations. Both groups were also monitored with fasting blood glucose measurements. The goal of insulin therapy was a preprandial value of 60 to 105 mg per deciliter (3.3 to 5.9 mmol per liter) or a postprandial value of less than 140 mg per deciliter (7.8 mmol per liter). Obstetrical data and information on neonatal outcomes were collected. RESULTS: The prepregnancy weight, weight gain during pregnancy, gestational age at the diagnosis of diabetes and at delivery, degree of compliance with therapy, and degree of achievement of target blood glucose concentrations were similar in the two groups. The mean (+/- SD) change in the glycosylated hemoglobin value was greater in the group in which postprandial measurements were used (-3.0 +/- 2.2 percent vs. 0.6 +/- 1.6 percent, P < 0.001) and the infants' birth weight was lower (3469 +/- 668 vs. 3848 +/- 434 g, P = 0.01). Similarly, the infants born to the women in the postprandial-monitoring group had a lower rate of neonatal hypoglycemia (3 percent vs. 21 percent, P = 0.05), were less often large for gestational age (12 percent vs. 42 percent, P = 0.01) and were less often delivered by cesarean section because of cephalopelvic disproportion (12 percent vs. 36 percent, P = 0.04) than those in the preprandial-monitoring group. CONCLUSIONS: Adjustment of insulin therapy in women with gestational diabetes according to the results of postprandial, rather than preprandial, blood glucose values improves glycemic control and decreases the risk of neonatal hypoglycemia, macrosomia, and cesarean delivery.
Adult↗
Management of insulin-dependent diabetes mellitus.
Insulin therapy has been lifesaving for patients with insulin-dependent diabetes mellitus. Unfortunately, longer lifespan has unmasked microvascular, neurological and macrovascular complications that result in profound morbidity and increased mortality. Driven by the conviction that better physiological control of glycaemic levels will prevent and/or ameliorate long term complications, and by the desire to make diabetes care as user-friendly as possible, clinical research efforts have led to the development of new treatment methods with the aim of achieving near normal metabolic control. Such methods include the use of self monitoring, multiple daily insulin injection regimens, external and implantable insulin pumps, and whole organ pancreas and isolated islet cell transplantation. In addition, dietary manipulation, including the use of alpha-glucosidase inhibitors, has played a role in controlling glycaemia.
Blood Glucose↗
Insulin-releasing pituitary cells as a model for somatic cell gene therapy in diabetes mellitus.
Insulin delivery by somatic cell gene therapy was evaluated using murine pituitary AtT20MtIns-1.4 cells. These cells have been stably transfected to release human insulin by the introduction of a recombinant plasmid bearing a human preproinsulin cDNA under the control of a zinc-sensitive metallothionein promoter. 6 x 10(7) AtT20MtIns-1.4 cells were implanted subcutaneously into streptozotocin-diabetic mice immunosuppressed with cyclosporin A. Release of human insulin was assessed using a specific plasma human C-peptide assay. On days 1 and 2 after implantation human C-peptide concentrations were about 0.02 pmol/ml. Consumption of zinc sulphate solution (500 mg/l) as drinking fluid for days 3-5 increased plasma human C-peptide concentrations to 0.11 +/- 0.01 pmol/ml (mean +/- S.E.M.), n = 11, P < 0.01, and concentrations declined when zinc was discontinued. The extent of hyperglycaemia was slightly lower (P < 0.05) than in a group implanted with non-transfected AtT20 cells. The study was terminated after 9 days, and tumour-like aggregations of implanted cells were identified at autopsy. These comprised a large necrotic core with insulin-containing cells at the periphery. The study provides support for the view that somatic cell gene therapy offers a potential approach to insulin delivery in diabetes mellitus.
Animals↗
The influence of diabetes mellitus and insulin therapy on biomechanical retention around dental implants: a study in rabbits.
The oral rehabilitation by dental implants in patients with diabetes remains a controversial issue. The aim of this study was to evaluate the influence of diabetes mellitus and insulin therapy on the bone healing around dental implants using torque removal. Twenty-seven rabbits were randomly divided into 3 groups with 9 animals each: control (C) group, induced diabetic (D) group, and insulin-treated diabetic (ITD) group (10 U/day). After 1 week, one implant was inserted at the tibial metaphysis of the animals. The glucose levels were periodically evaluated through the glucose-oxidase enzymatic method. The animals were killed at 4, 8, and 12 weeks after surgery and the biomechanical test was performed using a torque manometer. Statistically significant differences regarding the removal torque of the implant could not be found at 4 weeks (P = 0.2) among groups. Group C showed statistically higher values than groups D and ITD at the experimental periods of 8 (P = 0.0001 and P = 0.0002, respectively) and 12 weeks (P = 0.0053 and P = 0.001, respectively). There were no statistical differences between D and ITD groups in any of the experimental periods. Diabetes mellitus has negatively influenced the mechanical retention of implants placed at the tibial metaphysis of rabbits. Therapy with insulin did not induce any changes.
Analysis of Variance↗
Meta-analysis: efficacy and safety of inhaled insulin therapy in adults with diabetes mellitus.
BACKGROUND: Injection insulin therapy is not readily accepted by patients and many health care providers; therefore, less invasive options for insulin therapy are desirable. PURPOSE: To examine the efficacy, safety, and patient acceptability of inhaled insulin therapy in nonpregnant adults with diabetes mellitus. DATA SOURCES: English-language studies in MEDLINE, the Cochrane Clinical Trials Register (through June 2006), and U.S. Food and Drug Administration review documents of the first formulation of inhaled insulin approved for clinical use. STUDY SELECTION: Randomized, controlled trials of at least 12 weeks' duration that compared inhaled insulin with another active therapy and reported hemoglobin A1c levels in adults with type 1 or type 2 diabetes mellitus. DATA EXTRACTION: Two reviewers independently assessed trials for inclusion and extracted data. Differences were resolved by consensus. DATA SYNTHESIS: Sixteen open-label trials met the inclusion criteria (4023 patients; age range, 18 to 80 years). Among patients with type 1 or type 2 diabetes, there was a small decrease in hemoglobin A1c level from baseline that favored subcutaneous insulin over inhaled insulin (weighted mean difference, 0.08% [95% CI, 0.03% to 0.14%]), although there was no difference in the proportion of participants achieving hemoglobin A1c levels less than 7%. Inhaled insulin lowered hemoglobin A1c levels more (weighted mean difference favoring inhaled insulin, -1.45% [CI, -1.80% to - 1.10%]) compared with fixed doses of oral agents but much less when compared with oral agents titrated to glycemic efficacy (weighted mean difference favoring inhaled insulin, -0.20% [CI, -0.34% to - 0.07%]). Severe hypoglycemia was more likely to occur with inhaled insulin than with oral agents (risk ratio, 3.1 [CI, 1.0 to 9.1]), but there was no increased risk compared with subcutaneous insulin. There was an increased incidence of mild to moderate nonprogressive dry cough in patients treated with inhaled insulin (risk ratio, 3.5 [CI, 2.2 to 5.6]) and a mild decrease in certain pulmonary function testing variables, which did not progress over 2 years. Patients preferred inhaled insulin over subcutaneous insulin. LIMITATIONS: All trials were open label, which may introduce bias. Most of the trials were of 24 weeks' duration or less, limiting assessment of long-term safety. CONCLUSIONS: Inhaled insulin offers an alternative noninvasive option for premeal insulin administration, with glycemic efficacy slightly less than subcutaneous regular insulin and increased patient acceptability. Until long-term safety data are available, inhaled insulin should be reserved for nonpregnant adults with diabetes who are opposed to injections and who would otherwise delay appropriate and timely therapy with insulin.
Administration, Inhalation↗
Combinations sulfonylurea and insulin therapy in diabetes mellitus.
Management of diabetes mellitus (DM) continues to undergo evolutionary changes with further refinements as a result of enhanced understanding of the pathophysiology, technologic advances in glucose monitoring techniques and equipment, and an abundance of new drugs and insulin administration devices. Clearly, the maintenance of near normal blood glucose levels remains the prime goal of therapy in both noninsulin-dependent diabetes mellitus (NIDDM) and insulin-dependent diabetes mellitus (IDDM) especially in the light of the recent diabetes control and complications trial. In addition, the data has always supported the role of sustained hyperglycemia in precipitating diabetic ketosis and hyperglycemic nonketotic state, as well as recurrent infections and changes in lipid levels leading to atherosclerosis in large-sized and medium-sized arteries. Basic therapeutic modalities to achieve euglycemia in NIDDM patients remain the diet, exercise, oral agents, and insulin. Optimal management of associated medical disorders, such as hypertension and obesity, also is important to prevent the onset or progress of angiopathic complications. Combination therapy with insulin and oral agents is a frequently used treatment strategy in the last decade to achieve optimal metabolic control in this population if the therapy with oral agents alone fails to achieve this objective. Furthermore, in patients with IDDM manifesting extreme excursion of diurnal glycemia, this approach deserves trial as suggested in recent studies. However, it is imperative to assess this modality in light of the knowledge of pathophysiology of DM.
Diabetes Mellitus↗
[Insulin therapy in diabetes mellitus. Clinical experiences with a highly purified swine insulin].
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Adult↗
Changes in the mechanical properties of patellar tendon preparations of spontaneously diabetic dogs under long-term insulin therapy.
Diabetes mellitus is known to involve a wide range of musculoskeletal disorders including tendon contracture, tenosynovitis, joint stiffness, and osteoporosis. Recent studies with experimentally induced models of diabetes show that insulin therapy mitigates such alterations. These data are from relatively short-term experiments. This manuscript reports the results of tensile failure experiments on the canine patella-patellar tendon-tibia complex from a group of juvenile diabetic animals that received insulin therapy. The duration of the disease was 4-9 yr. The stiffness of the diabetic preparations in a physiological range of loading was approximately 13% greater than controls (P < 0.05). On the other hand, the strength of the tendon preparation from the diabetic population was not different from controls, but the mode of structural failure for controls was by substance and avulsion fractures while the diabetics failed by tensile fracture of the patella.
Aging↗