Continuous subcutaneous insulin infusion (CSII) versus conventional injection therapy in newly diagnosed diabetic children: two-year follow-up of a randomized, prospective trial.

The effect of continuous subcutaneous insulin infusion (CSII), begun at diagnosis, on blood glucose control and endogenous insulin production was studied in a group of consecutively referred newly diagnosed diabetic children. In a random order, 15 children started CSII (age 9.5 +/- 4.2 (+/- SD) years) and 15 conventional injection therapy (age 7.0 +/- 3.6 years). For 2 years HbA1 and urinary C-peptide were measured monthly, C-peptide responses to glucagon 6-monthly, and insulin antibodies every 3 months. None of the patients requested change of therapy during the study period, but at 28 months 1 adolescent girl changed to injection therapy from CSII. Severe hypoglycaemia was observed once in each group, but ketoacidosis only once, in the injection therapy group. From 2 months after diagnosis onwards the CSII group had significantly lower HbA1 levels. Urinary and plasma C-peptide levels did not differ between the two groups and similar insulin doses were used throughout the study. At the end of the 2 years of therapy, the CSII group had significantly lower insulin antibody levels. The observations suggest that CSII is well accepted in newly diagnosed children and improves metabolic control, but does not prolong endogenous insulin production.

Multiple daily insulin injections improve self-confidence.

The efficacy and psychosocial effects of multiple daily insulin injections (three preprandial injections of short-acting insulin (NovoPen) and once daily, bedtime extended-acting insulin) were compared with those of twice daily combinations of short- and intermediate-acting insulin, in a randomized crossover study (two 6-month periods), in 16 adult diabetic patients. HbA1 was not significantly different for the two treatment modalities (8.2 +/- 0.4 vs 7.6 +/- 0.4%). With the pen-injector regimen significantly less state anxiety (36.0 +/- 2.5 vs 39.5 +/- 2.7; p less than 0.05) was found than with the conventional syringe regimen. The patients tended to experience a better self-concept as having diabetes (32.0 +/- 2.1 vs 37.7 +/- 3.0; p less than 0.06), as well as less external ('chance') orientation (18.5 +/- 1.2 vs 20.7 +/- 1.6; p = 0.09) with the pen-injector regimen. A subgroup of patients with lower trait anxiety scores experienced less state anxiety during the pen-injector regimen than during twice daily insulin injections (30.6 +/- 2.6 vs 34.3 +/- 2.7; p less than 0.05). However, this subgroup tended to be less positive about injecting insulin during the pen-injector regimen (34.8 +/- 3.6 vs 29.6 +/- 4.0; p less than 0.08). The subgroup with higher trait anxiety scores experienced a better self-concept as having diabetes (35.3 +/- 2.3 vs 40.1 +/- 2.6; p less than 0.05) and a tendency towards less physician orientation (15.8 +/- 1.8 vs 19.6 +/- 2.7; p less than 0.07) with the pen-injector regimen. Thirteen patients continued with the pen-injector regimen.

Efficacy and acceptance of two intensified conventional insulin therapy regimens: a long-term cross-over comparison.

The efficacy and acceptability of multiple daily insulin injections (three preprandial injections of short-acting insulin (NovoPen) plus once daily extended-acting insulin) were compared with those of twice daily injections of short- and intermediate-acting insulin. Sixteen Type 1 diabetic patients participated in a cross-over study (6-month treatment periods). Total areas under 24-h plasma free insulin curves, assessed at the end of each study period, were not significantly different, but a greater area under this curve was found for the pen-injector regimen from 1200 to 1600 h (150 +/- 15 (SE) vs 106 +/- 7 mU l-1 h, p less than 0.01). Home blood glucose profiles showed significantly lower values with pen-injector therapy after lunch (7.1 +/- 0.6 vs 8.4 +/- 0.4 mmol l-1, p = 0.05) and before and after dinner (6.4 +/- 0.6 vs 8.8 +/- 0.5 mmol l-1, p less than 0.005, and 7.5 +/- 0.7 vs 9.4 +/- 1.1 mmol l-1, p less than 0.05). Mean daily blood glucose concentration was also lower (7.1 +/- 0.4 vs 8.2 +/- 0.5 mmol l-1, p less than 0.05). HbA1, fructosamine, hypoglycaemic reactions, and body weight were not significantly different. Thirteen patients decided to continue with pen-injector therapy at the end of the study.

The Medi-Jector II: efficacy and acceptability in insulin-dependent diabetic patients with and without needle phobia.

Efficacy and acceptability of the Medi-Jector II, compared with conventional syringes, was evaluated in a cross-over study (two 4-week periods) in 14 adult insulin-dependent diabetic patients. In 6 out of these 14 patients the clinical diagnosis of needle phobia was confirmed by anxiety tests for trait (45.8 +/- 12.8 (SD) versus 34.0 +/- 6.2; p less than 0.05) and state (50.3 +/- 10.9 versus 28.9 +/- 5.2, p less than 0.05). Five patients (one needle-phobic) dropped out, all for Medi-Jector-related problems. No significant differences were found in body weight, insulin dosage, and number of hypoglycaemic reactions. HbA1 after the Medi-Jector period was significantly higher than after the conventional period (9.8 +/- 1.2 (SE) versus 9.1 +/- 1.1 (SE)%; p less than 0.05). The questionnaire, evaluating the Medi-Jector, revealed poor acceptance of the device (7/9 patients' general impression being moderate or bad). The use of the Medi-Jector in comparison with conventional injections caused the patients to complain about: more immediate pain (4/9 patients), delayed pain (often: 4/9, sometimes: 2/9), more insulin leakage (6/9), more bleeding (6/9), and more haematomas (5/9). Except for 'often occurring delayed pain' (4/5 needle-phobics versus 0/4 non-needle-phobics; p less than 0.05), needle-phobic patients scored the questionnaire similarly to the other patients. We conclude that the use of the Medi-Jector II did not cause a major short-term loss of metabolic control, but that the device was not well accepted by our patients, independent of the existence of needle phobia.

Overnight metabolic profiles in very young insulin-dependent diabetic children.

UNLABELLED: The magnitude of the disturbance of metabolic control in diabetes mellitus in very young children has been recognised, but seldom studied. Limitations to studies are set by the difficulty of obtaining control data and until recently the lack of alternative therapies. Recently "mini" pumps for continuous subcutaneous insulin delivery have become available and may offer an alternative therapeutic possibility. The present investigation has been undertaken to collect overnight metabolic data of very young diabetic children (less than 6 years) controlled by standard injection therapy. During one admission to hospital frequent blood samples were collected for free insulin, glucose, alanine, lactate, glycerol and 3-hydroxybutyrate determinations. In all children (n = 9) the profiles showed a steep rise in glucose from 04.30 h (6.2 +/- 1.3 mmol/l) to 09.30 h (17.8 +/- 2.4 mmol/l) (the so-called "dawn-phenomenon"). The nature of the changes in the intermediary metabolites suggested that rise in blood glucose was caused by insufficient insulin. We have attempted to explore the time relationship between the overnight drop in free insulin levels and the rises in blood glucose by a distribution-free statistical analysis, correlating successive changes in time between the two profiles. The analysis suggested a delay of 2-6 h between free insulin levels and their effects. IN CONCLUSION: a clear "dawn phenomenon" is seen in very young diabetic children, and contributes to their poor glycaemic control. More stable and higher insulin concentrations in the early morning, obtained perhaps by continuous subcutaneous insulin infusion, might ameliorate the overall glycaemic control in the very young diabetic child.