LETTERS AND COMMENTS
TABLE 1 Quality-of-life change scores Change in injection frequency Life domain Illness Somatic Psychological Social Behavior/activity Habits* Life satisfaction Quality of life
No change 1.38 i t 1.00 dt 0.89 dt 0.33 dt 0.22 Ht 0.00 dt 0.33 it 0.59 dt
0.36 1.00 0.22 0.58 0.19 0.00 0.58 0.01
n
3 3 3 3 3 3 3 3
1.34 0.86 0.66 0.31 0.67 0.37 1.03 0.73
+1
n
± ± ± ± ± ± ± ±
29 28 29 29 28 29 29 24
0.67 1.01 0.64 0.58 0.83 0.72 1.15 0.64
1.36 0.87 0.80 0.41 0.84 0.41 0.79 0.82
+2
n
± ± ± ± ± ± ± ±
30 30 29 30 29 30 29 27
0.72 0.94 0.69 0.67 0.77 0.57 0.86 0.59
1.56 0.89 0.79 0.41 0.67 0.78 1.11 0.89
+3
n
r
± ± ± ± ± ± ± ±
9 9 9 9 9 9 9 9
0.08 -0.00 0.06 0.09 0.09 0.21 0.03 0.09
0.83 1.17 0.89 0.71 0.99 0.91 1.05 0.71
Values are means ± SD. *P - 0.08; all other P values NS.
previously required one or two syringe injections, implying a positive correlation between metabolic control and the increased injection frequency of the pen treatment. The aim of this study was to analyze whether increased injection frequency correlates to subsequent enhancement in quality of life. Forty-four male and 28 female outpatients with IDDM at the medical department at the hospital of Eksjo-Nassjo in Sweden comprised the study group. These included all patients >18 yr old who revisited the clinic between January and June 1988 and had switched from syringe therapy to insulin pen treatment 9-13 mo before their revisits. The study group represented 70% of all patients on insulin pen treatment in contact with the clinic during this period. Mean age and duration of diabetes of the study group were 40.9 ± 14.8 and 16.6 ± 9.8 yr, respectively. Perceived changes in quality of life attributed to the pen treatment were self-assessed retrospectively at a follow-up 9-13 mo after the switch to pen therapy. The quality-of-life assessment package used has been described elsewhere (5). Composite scores for five separate life-domain indices covering diabetic symptoms, habits, and psychological, social, and behavioral circumstances were calculated. A final composite index on the quality of life was calculated from all five lifedomain indices plus two single-item scores concerning perceived somatic health and global life satisfaction. The indices and scores ranged from - 3 (much deteriorated) to ^ 0 (unchanged) to +3 (much improved). Statistical analyses were run according to the SPSS/PC program (6). Mean quality-of-life change scores by change in injection frequency and intercorrelations are given in Table 1. Quality of life is obviously enhanced independently of the change in injection frequency. However, correlation between change in injection frequency and change in habits approaches significance. Tallroth et al. (4) concluded that the change in the multiple insulin regimen was the cause of the improvement in the quality of life recorded. The significance of the pen as a device was noted but not emphasized (4). The outcome of our study challenges the general con-
1136
clusion drawn by Tallroth et al. Our data support the superiority of the insulin pen as a management device. PER-OLOF ANDERSSON, MD ANDERS WIKBY, PhD JAN OLOF HORNQUIST, PhD From the Department of Internal Medicine, Hospital of Eksjo-Nassjo, and College of Health and Care, Eksjo; and Department of Community Medicine, Preventive and Social Medicine, Faculty of Health Sciences, Linkoping, Sweden. Address correspondence and reprint requests to Per-Olof Andersson, MD, Department of Internal Medicine, Hospital of Eksjo-Nassjo, S-57500 Eksjo, Sweden. ACKNOWLEDGMENTS
This work was supported by the County of Jonkoping and Swedish Medical Research Council Grants B88/89-27X08327-01A/02B and K88/89/90-27P-08466-01AK/02B/03A. REFERENCES
1. Editorial. Insulin pen: mightier than syringe? Lancet 1:307308, 1989 2. Andresen IL, Haug J, Jervell J, Paus PN: Treatment of diabetes and quality of life: on possibilities of a more normalized life style using an insulin pen for multi-injection therapy. Tidsskr Nor Laegeforen 109:677-80, 1989 3. Buysschaert M, Janne P, Mpoy M, Reynaert C, Pirson F, Cassiers L, Lambert AE: Metabolic and psychological evolution of insulin dependent diabetic patients during a 6 months insulin pen treatment. Diabete Metab 14:75-79, 1988 4. Tallroth G, Karlson B, Nilsson A, Agardh C-D: The influence of different insulin regimens on quality of life and metabolic control in insulin dependent diabetics. Diabetes ResClin Pract 6:37-43, 1989 5. Hornquist JO: Quality of life: concept and assessment. Scand) Soc Med 18:69-79, 1989 6. Norusis MJ: SPSS/PC + for the IBM PCIXTI AT. New York, SPSS, 1986
Insulin Pens in Elderly Diabetic Patients The use of insulin pens for application of regular insulin is well established (1-4). Few critical remarks have been
DIABETES CARE, VOL. 13, NO. 11, NOVEMBER 1990
LETTERS AND COMMENTS
published concerning ketoacidosis under pen treatment (5) and indication for pen therapy (6). New insulin pens for use with NPH and mixed insulins are now available (7,8). Therefore, patients on intensive conventional insulin therapy and elderly patients on conventional therapy may profit from these pens. To study the usefulness of insulin pens in elderly patients, we compared the insulin pens available for intermediate-acting (NPH) and mixed insulins. The NovoPen II (Novo), Optipen 2 or 4 (Hoechst), and the Insuject X (Nordisk) insulin pens were used in the study. Dosage precision was tested by determining the weight of a volume of water equivalent to 4 U of a U-100 insulin (40 |xl) 15 times for each of five devices. Mean ± SE weight of 4 U was 0.0393 ± 0.001 g. Whereas significant differences were noted between the volume dispensed by different pens, precision in pens was better than that obtained in studies where conventional syringes were investigated (9). Patients (mean age 63 yr, range 44-81 yr) with little prior training in diet, glucose monitoring, and insulin injection technique received one pen (NPH or mixed insulin) from each company. Pens were changed every 4 wk. Each patient tested every pen of every company randomly. HbA, was controlled monthly, and insulin dosage was corrected according to the results of selfmonitored blood glucose (SMBG) or actual blood glucose values. To allow for different life-styles, the timing and number of SMBGs were not regulated. After each period, patients were asked about the function and handling of the pen and injection button, pain caused by the injection, impressions of the weight and size of the pen, quality of their life, and any feelings of independence due to the use of the pen. Number and intensity of hypoglycemic events were registered. Patients were asked at the end of the study whether they wanted to continue using a pen and, if so, which they preferred. Ten of 18 patients completed this 3-mo randomized prospective crossover trial. Glycemic control remained unchanged with regard to HbA, (9.9 vs. 8.2%, NS for P = 0.05) but showed a decreasing tendency. The patients expressed strong approval of the pens, citing easier and faster insulin injection, greater comfort, and far less pain. Patients needed up to 1 h of instruction, with some patients needing repeated instruction. In contrast to patients of a control group on intensive conventional therapy (n = 20, mean age 37 yr, range 15-68 yr), elderly patients needed more time than younger patients to learn the different functions of different pens. Due to polyarthrosis, some patients had difficulty pressing the button. These patients preferred the Insuject X with its big turning button, which could be switched on with one hand. None of the patients wanted to return to syringes. In 2 cases, pens had to be withdrawn because of patients' inability to correctly handle. Six patients
DIABETES CARE, VOL. 13, NO. 11, NOVEMBER 1990
wanted to continue using their first pen. No preference for one pen over another was noted. Regulation of diabetes with insulin pens was easily achieved, as shown by others (1-4). For use of NPH or mixed insulins, Optipen 2 or 4, NovoPen II, or Insuject X can be considered better than conventional syringes; however, none of the insulin pens proved to be better than the others. Recently, it was asked whether insulin pens were mightier than syringes. This might be the case for a welleducated highly motivated patient prepared to monitor blood glucose frequently (10). We think that many elderly and less-trained patients may also profit from pen therapy. KARL-MICHAEL REINAUER, MD GRECOR JOKSCH WALTER RENN, PhD MANFRED ECGSTEIN, MD
From the Department of Clinical Chemistry, Metabolism, and Endocrinology Medical Clinic, Eberhard-Karls-University, Tubingen, Federal Republic of Germany. Address correspondence and reprint requests to Dr. Karl-Michael Reinauer, Eberhard-Karls-Universitat, Medizinische Klinik, Otfried-Mtiller-Strasse 10, D-7400 Tubingen, FRG.
REFERENCES
1. Berger AS, Saurbrey N, Kuhl C, Villumsen J: Clinical experience with a new device that will simplify insulin injections. Diabetes Care 8:73-76, 1985 2. Murray DP, Keenan P, Gayer E, Salmon P, Tomkin GH, Drury Ml, O'Sullivan DJ: A randomized trial of the efficacy and acceptability of a pen injector. Diabetic Med 5:750-54, 1988 3. Buysschaert M, Janne P, Mpoy M, Reynaert C, Pirson F, Cassiers L, Lambert AE: Metabolic and psychological evolution of insulin dependent diabetic patients during a 6 month insulin-pen treatment. Diabete Metab 14:75—79, 1988 4. Stracke H, Federlin K: Insulin-Therapie mit einem neuen Injektionsgerat: Erfahrungen bei 36 Typ-I-Diabetikern. Dtsch Med Wochenschr 112:385-88, 1987 5. MacRury SM, Small M, Boal A, Paterson KR, McCuish AC: Diabetic ketoacidosis during NovoPen therapy. Diabetic Med 5:87-88, 1988 6. Teupe B, Bergis K: Insulintherapie: Basis-Bolus-Prinzip (Letter). Dtsch Med Wochenschr 112:1189, 1987 7. Jorgensen JOL, Flyvbjerg A, Jorgensen JT, Holmegaard Sorensen H, Rose Johansen B, Christiansen JS: NPH insulin administration by means of a pen injector. Diabetic Med 5:574-76, 1988 8. Kolendorf K, Beck-Nielsen H, Oxenboll B: Clinical experience with NovoPen II and insulin protaphane penfill. Postgrad Med I 64 (Suppl. 3): 14-16, 1988 9. Skodda H, Warzecha P, Muhlhauser I, Kemmer FW, Jorgens V: The quality of different insulin syringes (Abstract). Diabetologia 25:194, 1983 10. Editorial: Insulin pen: mightier than syringe? Lancet 1: 307-308, 1989
1137
TABLE 1 Quality-of-life change scores Change in injection frequency Life domain Illness Somatic Psychological Social Behavior/activity Habits* Life satisfaction Quality of life
No change 1.38 i t 1.00 dt 0.89 dt 0.33 dt 0.22 Ht 0.00 dt 0.33 it 0.59 dt
0.36 1.00 0.22 0.58 0.19 0.00 0.58 0.01
n
3 3 3 3 3 3 3 3
1.34 0.86 0.66 0.31 0.67 0.37 1.03 0.73
+1
n
± ± ± ± ± ± ± ±
29 28 29 29 28 29 29 24
0.67 1.01 0.64 0.58 0.83 0.72 1.15 0.64
1.36 0.87 0.80 0.41 0.84 0.41 0.79 0.82
+2
n
± ± ± ± ± ± ± ±
30 30 29 30 29 30 29 27
0.72 0.94 0.69 0.67 0.77 0.57 0.86 0.59
1.56 0.89 0.79 0.41 0.67 0.78 1.11 0.89
+3
n
r
± ± ± ± ± ± ± ±
9 9 9 9 9 9 9 9
0.08 -0.00 0.06 0.09 0.09 0.21 0.03 0.09
0.83 1.17 0.89 0.71 0.99 0.91 1.05 0.71
Values are means ± SD. *P - 0.08; all other P values NS.
previously required one or two syringe injections, implying a positive correlation between metabolic control and the increased injection frequency of the pen treatment. The aim of this study was to analyze whether increased injection frequency correlates to subsequent enhancement in quality of life. Forty-four male and 28 female outpatients with IDDM at the medical department at the hospital of Eksjo-Nassjo in Sweden comprised the study group. These included all patients >18 yr old who revisited the clinic between January and June 1988 and had switched from syringe therapy to insulin pen treatment 9-13 mo before their revisits. The study group represented 70% of all patients on insulin pen treatment in contact with the clinic during this period. Mean age and duration of diabetes of the study group were 40.9 ± 14.8 and 16.6 ± 9.8 yr, respectively. Perceived changes in quality of life attributed to the pen treatment were self-assessed retrospectively at a follow-up 9-13 mo after the switch to pen therapy. The quality-of-life assessment package used has been described elsewhere (5). Composite scores for five separate life-domain indices covering diabetic symptoms, habits, and psychological, social, and behavioral circumstances were calculated. A final composite index on the quality of life was calculated from all five lifedomain indices plus two single-item scores concerning perceived somatic health and global life satisfaction. The indices and scores ranged from - 3 (much deteriorated) to ^ 0 (unchanged) to +3 (much improved). Statistical analyses were run according to the SPSS/PC program (6). Mean quality-of-life change scores by change in injection frequency and intercorrelations are given in Table 1. Quality of life is obviously enhanced independently of the change in injection frequency. However, correlation between change in injection frequency and change in habits approaches significance. Tallroth et al. (4) concluded that the change in the multiple insulin regimen was the cause of the improvement in the quality of life recorded. The significance of the pen as a device was noted but not emphasized (4). The outcome of our study challenges the general con-
1136
clusion drawn by Tallroth et al. Our data support the superiority of the insulin pen as a management device. PER-OLOF ANDERSSON, MD ANDERS WIKBY, PhD JAN OLOF HORNQUIST, PhD From the Department of Internal Medicine, Hospital of Eksjo-Nassjo, and College of Health and Care, Eksjo; and Department of Community Medicine, Preventive and Social Medicine, Faculty of Health Sciences, Linkoping, Sweden. Address correspondence and reprint requests to Per-Olof Andersson, MD, Department of Internal Medicine, Hospital of Eksjo-Nassjo, S-57500 Eksjo, Sweden. ACKNOWLEDGMENTS
This work was supported by the County of Jonkoping and Swedish Medical Research Council Grants B88/89-27X08327-01A/02B and K88/89/90-27P-08466-01AK/02B/03A. REFERENCES
1. Editorial. Insulin pen: mightier than syringe? Lancet 1:307308, 1989 2. Andresen IL, Haug J, Jervell J, Paus PN: Treatment of diabetes and quality of life: on possibilities of a more normalized life style using an insulin pen for multi-injection therapy. Tidsskr Nor Laegeforen 109:677-80, 1989 3. Buysschaert M, Janne P, Mpoy M, Reynaert C, Pirson F, Cassiers L, Lambert AE: Metabolic and psychological evolution of insulin dependent diabetic patients during a 6 months insulin pen treatment. Diabete Metab 14:75-79, 1988 4. Tallroth G, Karlson B, Nilsson A, Agardh C-D: The influence of different insulin regimens on quality of life and metabolic control in insulin dependent diabetics. Diabetes ResClin Pract 6:37-43, 1989 5. Hornquist JO: Quality of life: concept and assessment. Scand) Soc Med 18:69-79, 1989 6. Norusis MJ: SPSS/PC + for the IBM PCIXTI AT. New York, SPSS, 1986
Insulin Pens in Elderly Diabetic Patients The use of insulin pens for application of regular insulin is well established (1-4). Few critical remarks have been
DIABETES CARE, VOL. 13, NO. 11, NOVEMBER 1990
LETTERS AND COMMENTS
published concerning ketoacidosis under pen treatment (5) and indication for pen therapy (6). New insulin pens for use with NPH and mixed insulins are now available (7,8). Therefore, patients on intensive conventional insulin therapy and elderly patients on conventional therapy may profit from these pens. To study the usefulness of insulin pens in elderly patients, we compared the insulin pens available for intermediate-acting (NPH) and mixed insulins. The NovoPen II (Novo), Optipen 2 or 4 (Hoechst), and the Insuject X (Nordisk) insulin pens were used in the study. Dosage precision was tested by determining the weight of a volume of water equivalent to 4 U of a U-100 insulin (40 |xl) 15 times for each of five devices. Mean ± SE weight of 4 U was 0.0393 ± 0.001 g. Whereas significant differences were noted between the volume dispensed by different pens, precision in pens was better than that obtained in studies where conventional syringes were investigated (9). Patients (mean age 63 yr, range 44-81 yr) with little prior training in diet, glucose monitoring, and insulin injection technique received one pen (NPH or mixed insulin) from each company. Pens were changed every 4 wk. Each patient tested every pen of every company randomly. HbA, was controlled monthly, and insulin dosage was corrected according to the results of selfmonitored blood glucose (SMBG) or actual blood glucose values. To allow for different life-styles, the timing and number of SMBGs were not regulated. After each period, patients were asked about the function and handling of the pen and injection button, pain caused by the injection, impressions of the weight and size of the pen, quality of their life, and any feelings of independence due to the use of the pen. Number and intensity of hypoglycemic events were registered. Patients were asked at the end of the study whether they wanted to continue using a pen and, if so, which they preferred. Ten of 18 patients completed this 3-mo randomized prospective crossover trial. Glycemic control remained unchanged with regard to HbA, (9.9 vs. 8.2%, NS for P = 0.05) but showed a decreasing tendency. The patients expressed strong approval of the pens, citing easier and faster insulin injection, greater comfort, and far less pain. Patients needed up to 1 h of instruction, with some patients needing repeated instruction. In contrast to patients of a control group on intensive conventional therapy (n = 20, mean age 37 yr, range 15-68 yr), elderly patients needed more time than younger patients to learn the different functions of different pens. Due to polyarthrosis, some patients had difficulty pressing the button. These patients preferred the Insuject X with its big turning button, which could be switched on with one hand. None of the patients wanted to return to syringes. In 2 cases, pens had to be withdrawn because of patients' inability to correctly handle. Six patients
DIABETES CARE, VOL. 13, NO. 11, NOVEMBER 1990
wanted to continue using their first pen. No preference for one pen over another was noted. Regulation of diabetes with insulin pens was easily achieved, as shown by others (1-4). For use of NPH or mixed insulins, Optipen 2 or 4, NovoPen II, or Insuject X can be considered better than conventional syringes; however, none of the insulin pens proved to be better than the others. Recently, it was asked whether insulin pens were mightier than syringes. This might be the case for a welleducated highly motivated patient prepared to monitor blood glucose frequently (10). We think that many elderly and less-trained patients may also profit from pen therapy. KARL-MICHAEL REINAUER, MD GRECOR JOKSCH WALTER RENN, PhD MANFRED ECGSTEIN, MD
From the Department of Clinical Chemistry, Metabolism, and Endocrinology Medical Clinic, Eberhard-Karls-University, Tubingen, Federal Republic of Germany. Address correspondence and reprint requests to Dr. Karl-Michael Reinauer, Eberhard-Karls-Universitat, Medizinische Klinik, Otfried-Mtiller-Strasse 10, D-7400 Tubingen, FRG.
REFERENCES
1. Berger AS, Saurbrey N, Kuhl C, Villumsen J: Clinical experience with a new device that will simplify insulin injections. Diabetes Care 8:73-76, 1985 2. Murray DP, Keenan P, Gayer E, Salmon P, Tomkin GH, Drury Ml, O'Sullivan DJ: A randomized trial of the efficacy and acceptability of a pen injector. Diabetic Med 5:750-54, 1988 3. Buysschaert M, Janne P, Mpoy M, Reynaert C, Pirson F, Cassiers L, Lambert AE: Metabolic and psychological evolution of insulin dependent diabetic patients during a 6 month insulin-pen treatment. Diabete Metab 14:75—79, 1988 4. Stracke H, Federlin K: Insulin-Therapie mit einem neuen Injektionsgerat: Erfahrungen bei 36 Typ-I-Diabetikern. Dtsch Med Wochenschr 112:385-88, 1987 5. MacRury SM, Small M, Boal A, Paterson KR, McCuish AC: Diabetic ketoacidosis during NovoPen therapy. Diabetic Med 5:87-88, 1988 6. Teupe B, Bergis K: Insulintherapie: Basis-Bolus-Prinzip (Letter). Dtsch Med Wochenschr 112:1189, 1987 7. Jorgensen JOL, Flyvbjerg A, Jorgensen JT, Holmegaard Sorensen H, Rose Johansen B, Christiansen JS: NPH insulin administration by means of a pen injector. Diabetic Med 5:574-76, 1988 8. Kolendorf K, Beck-Nielsen H, Oxenboll B: Clinical experience with NovoPen II and insulin protaphane penfill. Postgrad Med I 64 (Suppl. 3): 14-16, 1988 9. Skodda H, Warzecha P, Muhlhauser I, Kemmer FW, Jorgens V: The quality of different insulin syringes (Abstract). Diabetologia 25:194, 1983 10. Editorial: Insulin pen: mightier than syringe? Lancet 1: 307-308, 1989
1137
