JOURNAL OF ADOLESCENT HEALTH 1991;12:373-376
H. PETER CHASE, M.D.,
SATISH K. GARG, M.D.,
SHERRIE HARRIS, B.S.N.,
SANDY L HOOFS, C.H.A.,
AND WILLIAM WILCOX, M.D.
The present report describes our experience with 16 adDennis and young aduits with insulin-delpendent diabetes mellitus !IDDM; Type I) who switched from two injections of insulin per day to the NovolinPen and four insulin injections a day. Their mean age at the initiation of therapy was 19.2 years with a duration of diabetes of 8.9 years. Sixteen random computer-matched (for age, sex, and duration of diabetes) controls who remained on two insulin injections a day were evaluated for comparison. Most subjects were preparing to ieave home for college. After a minimum of 1 year of using the pen, the mean weight gain of the test subjects was significantly greater (P < .05! than for the computer-matched controls. Glycemic control, as monitored by mean HbA,, values, were similar for the NovolinPen and the control groups (10.8 versus 10.9, respectively) after ahrlost 2 years. The main advantage to the pen expressed by the users was a sense of freedom of lifestyle. KEYWORDS:
Insulin-dependent diabetes mellitus NovolinPen Glycohemoglobin (HbA,J College students Intensive insulin therapy (IIT) Us?, of the NovolinPen by adolescents and young adults with insulin-dependent diabetes melliitus (IDDM; Type I) has become increasingly popular in
Fromthe University of Colorado Health Sciexes Center, BUrbaw . ..“L..,, Y l&UC, j, c%viidti. *em-Davis Cmter b4 C&ld!md I?“h-+ Addressreprint requests to: H. Peber Chase, M.D., UCHS:‘Bok B140, 4200 East 9th Avenue, Denver,CtJ 80262. bfmuwript lafcepted April 22, 1991.
recent years (1). Yhe NovolinPcn is 3 fountam penlike dial-a-dose :lnsulin delivery device. The patients can carry the pen and give injections of regular insulin when a meal is to be eaten. This may be more physiologic than two injections per day anl better control post-prandial hyperglycemic peaks. A longacting insulin (Ultralente) is taken once or twice daily to meet basehne insulin requiremenrs. Current &scriptions of pen usage have been primarily in adults, with a maximum duration of usage of 4 months (2). A major reason health-care providers suggest the Novolinl’en to patients is the hope for improved metabolic control. Good glycemic control, as mcasured by longitudinal glycohemoglobin (I-IbA,,) values, may be important in preventing or delaying the eye and kidney ccmplications of diabetes (3). lvietabolic control in the Diabetes Control and CompPcations Trial (4) improved in a highly selected group receiving more than two injections per day (intensive insulin therapy) and extensive individualized attention. However, whether patients in a routine clinic setting would have similar improvement in metabolic control while taking four injections per day ha.< not been assessed. The purpose of this report is 10 describe our experience with adolescents and young adu!.ts with IDDM, most of whom were college students, who used the NovolinPen for a minimum of 1 year.
to the Twenty-two subjects were introduced NovolinPen at the time of our annual college work-
0 Society for Adolesceni Medicine, 1Wl Published by Elsevier science Publishing Co., Inc., 655 Avenue of the Americas, New York, NY lUOl0
373 0197-0070191/53.50
374
CHASE El’ AL.
shops in 1988 and 1289. This workshop is open to all seniors in high school who have diabetes. All subjects were tcid of the requirement of more frequent self-blood gluco3c monitoring (4 times daily) if they ddded to change to the pen. Thirteen of the subjects chose to try it. The other three subjects in the test group were j’oung adults desiring schedule flexibiI@. After having used the NovolinPen for at least .l year, the 16 test subjects were matched for gender, chronologic nge, ethnic background, and daration of diabetes with the 16 closest computern:atched diabetic controls (matched from 1579 subjects followed at our center). Ten of the control subjects were attending college compared to 13 of the test subjects. All subjects were on two injections per day of regular and NPH insulin before switching to the three premeal Injections of regular insulin with the NovolinPen and one injection a day of human Ultralente insulin using an insulin syringe. Subjects were initially changed to the same total dosage of insulin they were previously receiving. Blood glucose results were reported after 1 week (or sooner .,., 7Gmg/dL or greater than 300 if valries were ~&VAmg/dL or if hypoglycemic reactions occurred), and insulin dosages were adjusted accordingly. If fasting morning blood glucose levels were consistently above 150 mg/dL, the Ultralente insulin was increased by 2 units every 3-7 days until glucose values were between 70-150 mg/dL. Similarly, the Ultralentc dosages were decp?sed for fasting glucose values below 70 mg/dL. All subjects were started on tither 6 or 8 units of regular iblsulin prior lo each Jlleal. Dosages were decreased or increased by 2 units if blood glucose values below 70 mg/dL or abaive 200 mg/dL were detected in the next 4 hr. All subjects were following a sugar-restricted diet (5) and were as&d to reduce premeal dosages (usually t*] 2 units) if they were eating less or exercising more. The total and fractional insulin dosages received at the introduction of the NovolinPen and after 3, 6, 9, and 12 months were prospectively recorded. All subj&s followed in our clinic have telephone numbers te contact us as needed. Subjects who were changed to the multiple injection regimen were asked to report blood sugars weekly for the first 2-4 weeks. All 16 subjects used the NovolinPen for at least 1 year without any interruption and had regular (every 3 months) HbA,, determinations. The I-lb&, levels were measured using ion exchange resin (Is&b Fast hemoglobin Test System, Isolab, Inc., Ak-
JOURNAL OF ADOL ESCEM I’ HEALTH Voi. 12, NO. 5
ron, Ohio). Since 1979, I-&A,, valu .05) characteristics to those who chose the pen (menn age, 20 jr jr?dia, hedn dur-anon of diabetes, 9.1 years; mean HbA,,, 10.5%; all Caucasian and five females). The test subjects gained a mean (2 SEM) of 1.9 -k 0.5 Kg compared to a mean (+ SEW) of 0.2 & 0.9 Kg for the computer-matched controls (P < 0.05, unpaired t test). The mean weights at ei ,J?~oi .I& four time periods were similar (P > .05, unpaired i test). Meax total insulin dosages in -units/24 hr were similar in the control and test subjects 1 year before starting the NovolinPen (61.4 and 61.2, respectively) and it the time of starting the NovolinPen (64.0 for test sublects, 65.1 for controls). After 1 year, the NovolinPen-treeted subjects had a slightly higher insulin dosage thotigh not statistically significant (67.5 versus 63.3 U/day: i=‘- .40, unpaired t testj. All subjects stated they were cl;z@&u-tt with the multiple-shot regimen on weekdays.. However,
ruly 1991
most subjects admitted to eating only two meals and taking two injections of regular insulin on weekends and holiday 5. The HbA,, levels were similar between the two groups. At 12 months, 11 controls and 10 ; :st subjecPc; had similar values (within 10%) of thelr initial values. Four control and five test subjects had an improvement (greater than 10% decline) and one in each group worsened (greater than 10% increase). The mean levels for the test and the control subjects were similar throughout the period of study (P > .O5, unpaired t test). There were no episodes of severe hypoglycemia or of ketoacidosis in either groups before or during the period of study. Novolir#en-treated subjects received a mcinn of 75% of their total daily insulin as Ultralente at the start of the strldy and 72% at the end of 12 months. The ;nean dosages of re@ar insulin before breakfast, lunch, and dinner airas 8 units (range, 4-14 units) at the beginning l-i- :he study; and 9, 10, and 10 units, respectively, [range, 4-15 units) after 1 year. Using the National Patient Lifestyle and Experience Survey more than one half of the subjects gave satisfactory responses (levels 4 or 5) for all questions except for questions 7 and 8 (“Novo!inPen makes it easier to take an insulin dose more discreetly” and “NovolinPen has improved my attitude tow& taking an insulin shot”). Over one half of the subjects responded at the l-3 le$s_-for these two questions. All subjects strrm$y agreed (level 5) with the statcment “Away from home, NovolinPen injections are more convenient than syringe injections.”
This study compares a multiple-shot intensive irasulin regimen with conventional therapy. Thirteen of the 16 subjects using the NovolinPen were college studen& who needed dosage flexibility owing to class schedules. When taking two intermediateacting insulin Injections, little latitude in meal times was possible. The advantage expressed in the NovolinPen Lifestyle and Experience Survey by over one half of the NovolinPen users after 1 year was a sense of freedom of lifestyle. The control subjects were not asked similar questions so the possibility exists that this “sense of freedom” ‘was related to being away from home. A common time for edolescents to assume complete responsibility for management of their chronic disease is whc:: they leave
NOVC’:ANPEN@ FOR U-J ‘N COLLEGE SI’UQENTS
375
home to atten: college. We could find no reports of youth with diab- I s2s and how they managed as they left home to attend college. The youth In our report appeared to have managed well. Glucose control in our subjects remained similar, as reported previOU.S~Y for adults who switched to pen injectors {2,7,8), and there were no episodes of ketoacidosis or of severe hypoglycemia in the study or control groups. The main benefit expected was improvement in &%A:
H. PETER CHASE, M.D.,
SATISH K. GARG, M.D.,
SHERRIE HARRIS, B.S.N.,
SANDY L HOOFS, C.H.A.,
AND WILLIAM WILCOX, M.D.
The present report describes our experience with 16 adDennis and young aduits with insulin-delpendent diabetes mellitus !IDDM; Type I) who switched from two injections of insulin per day to the NovolinPen and four insulin injections a day. Their mean age at the initiation of therapy was 19.2 years with a duration of diabetes of 8.9 years. Sixteen random computer-matched (for age, sex, and duration of diabetes) controls who remained on two insulin injections a day were evaluated for comparison. Most subjects were preparing to ieave home for college. After a minimum of 1 year of using the pen, the mean weight gain of the test subjects was significantly greater (P < .05! than for the computer-matched controls. Glycemic control, as monitored by mean HbA,, values, were similar for the NovolinPen and the control groups (10.8 versus 10.9, respectively) after ahrlost 2 years. The main advantage to the pen expressed by the users was a sense of freedom of lifestyle. KEYWORDS:
Insulin-dependent diabetes mellitus NovolinPen Glycohemoglobin (HbA,J College students Intensive insulin therapy (IIT) Us?, of the NovolinPen by adolescents and young adults with insulin-dependent diabetes melliitus (IDDM; Type I) has become increasingly popular in
Fromthe University of Colorado Health Sciexes Center, BUrbaw . ..“L..,, Y l&UC, j, c%viidti. *em-Davis Cmter b4 C&ld!md I?“h-+ Addressreprint requests to: H. Peber Chase, M.D., UCHS:‘Bok B140, 4200 East 9th Avenue, Denver,CtJ 80262. bfmuwript lafcepted April 22, 1991.
recent years (1). Yhe NovolinPcn is 3 fountam penlike dial-a-dose :lnsulin delivery device. The patients can carry the pen and give injections of regular insulin when a meal is to be eaten. This may be more physiologic than two injections per day anl better control post-prandial hyperglycemic peaks. A longacting insulin (Ultralente) is taken once or twice daily to meet basehne insulin requiremenrs. Current &scriptions of pen usage have been primarily in adults, with a maximum duration of usage of 4 months (2). A major reason health-care providers suggest the Novolinl’en to patients is the hope for improved metabolic control. Good glycemic control, as mcasured by longitudinal glycohemoglobin (I-IbA,,) values, may be important in preventing or delaying the eye and kidney ccmplications of diabetes (3). lvietabolic control in the Diabetes Control and CompPcations Trial (4) improved in a highly selected group receiving more than two injections per day (intensive insulin therapy) and extensive individualized attention. However, whether patients in a routine clinic setting would have similar improvement in metabolic control while taking four injections per day ha.< not been assessed. The purpose of this report is 10 describe our experience with adolescents and young adu!.ts with IDDM, most of whom were college students, who used the NovolinPen for a minimum of 1 year.
to the Twenty-two subjects were introduced NovolinPen at the time of our annual college work-
0 Society for Adolesceni Medicine, 1Wl Published by Elsevier science Publishing Co., Inc., 655 Avenue of the Americas, New York, NY lUOl0
373 0197-0070191/53.50
374
CHASE El’ AL.
shops in 1988 and 1289. This workshop is open to all seniors in high school who have diabetes. All subjects were tcid of the requirement of more frequent self-blood gluco3c monitoring (4 times daily) if they ddded to change to the pen. Thirteen of the subjects chose to try it. The other three subjects in the test group were j’oung adults desiring schedule flexibiI@. After having used the NovolinPen for at least .l year, the 16 test subjects were matched for gender, chronologic nge, ethnic background, and daration of diabetes with the 16 closest computern:atched diabetic controls (matched from 1579 subjects followed at our center). Ten of the control subjects were attending college compared to 13 of the test subjects. All subjects were on two injections per day of regular and NPH insulin before switching to the three premeal Injections of regular insulin with the NovolinPen and one injection a day of human Ultralente insulin using an insulin syringe. Subjects were initially changed to the same total dosage of insulin they were previously receiving. Blood glucose results were reported after 1 week (or sooner .,., 7Gmg/dL or greater than 300 if valries were ~&VAmg/dL or if hypoglycemic reactions occurred), and insulin dosages were adjusted accordingly. If fasting morning blood glucose levels were consistently above 150 mg/dL, the Ultralente insulin was increased by 2 units every 3-7 days until glucose values were between 70-150 mg/dL. Similarly, the Ultralentc dosages were decp?sed for fasting glucose values below 70 mg/dL. All subjects were started on tither 6 or 8 units of regular iblsulin prior lo each Jlleal. Dosages were decreased or increased by 2 units if blood glucose values below 70 mg/dL or abaive 200 mg/dL were detected in the next 4 hr. All subjects were following a sugar-restricted diet (5) and were as&d to reduce premeal dosages (usually t*] 2 units) if they were eating less or exercising more. The total and fractional insulin dosages received at the introduction of the NovolinPen and after 3, 6, 9, and 12 months were prospectively recorded. All subj&s followed in our clinic have telephone numbers te contact us as needed. Subjects who were changed to the multiple injection regimen were asked to report blood sugars weekly for the first 2-4 weeks. All 16 subjects used the NovolinPen for at least 1 year without any interruption and had regular (every 3 months) HbA,, determinations. The I-lb&, levels were measured using ion exchange resin (Is&b Fast hemoglobin Test System, Isolab, Inc., Ak-
JOURNAL OF ADOL ESCEM I’ HEALTH Voi. 12, NO. 5
ron, Ohio). Since 1979, I-&A,, valu .05) characteristics to those who chose the pen (menn age, 20 jr jr?dia, hedn dur-anon of diabetes, 9.1 years; mean HbA,,, 10.5%; all Caucasian and five females). The test subjects gained a mean (2 SEM) of 1.9 -k 0.5 Kg compared to a mean (+ SEW) of 0.2 & 0.9 Kg for the computer-matched controls (P < 0.05, unpaired t test). The mean weights at ei ,J?~oi .I& four time periods were similar (P > .05, unpaired i test). Meax total insulin dosages in -units/24 hr were similar in the control and test subjects 1 year before starting the NovolinPen (61.4 and 61.2, respectively) and it the time of starting the NovolinPen (64.0 for test sublects, 65.1 for controls). After 1 year, the NovolinPen-treeted subjects had a slightly higher insulin dosage thotigh not statistically significant (67.5 versus 63.3 U/day: i=‘- .40, unpaired t testj. All subjects stated they were cl;z@&u-tt with the multiple-shot regimen on weekdays.. However,
ruly 1991
most subjects admitted to eating only two meals and taking two injections of regular insulin on weekends and holiday 5. The HbA,, levels were similar between the two groups. At 12 months, 11 controls and 10 ; :st subjecPc; had similar values (within 10%) of thelr initial values. Four control and five test subjects had an improvement (greater than 10% decline) and one in each group worsened (greater than 10% increase). The mean levels for the test and the control subjects were similar throughout the period of study (P > .O5, unpaired t test). There were no episodes of severe hypoglycemia or of ketoacidosis in either groups before or during the period of study. Novolir#en-treated subjects received a mcinn of 75% of their total daily insulin as Ultralente at the start of the strldy and 72% at the end of 12 months. The ;nean dosages of re@ar insulin before breakfast, lunch, and dinner airas 8 units (range, 4-14 units) at the beginning l-i- :he study; and 9, 10, and 10 units, respectively, [range, 4-15 units) after 1 year. Using the National Patient Lifestyle and Experience Survey more than one half of the subjects gave satisfactory responses (levels 4 or 5) for all questions except for questions 7 and 8 (“Novo!inPen makes it easier to take an insulin dose more discreetly” and “NovolinPen has improved my attitude tow& taking an insulin shot”). Over one half of the subjects responded at the l-3 le$s_-for these two questions. All subjects strrm$y agreed (level 5) with the statcment “Away from home, NovolinPen injections are more convenient than syringe injections.”
This study compares a multiple-shot intensive irasulin regimen with conventional therapy. Thirteen of the 16 subjects using the NovolinPen were college studen& who needed dosage flexibility owing to class schedules. When taking two intermediateacting insulin Injections, little latitude in meal times was possible. The advantage expressed in the NovolinPen Lifestyle and Experience Survey by over one half of the NovolinPen users after 1 year was a sense of freedom of lifestyle. The control subjects were not asked similar questions so the possibility exists that this “sense of freedom” ‘was related to being away from home. A common time for edolescents to assume complete responsibility for management of their chronic disease is whc:: they leave
NOVC’:ANPEN@ FOR U-J ‘N COLLEGE SI’UQENTS
375
home to atten: college. We could find no reports of youth with diab- I s2s and how they managed as they left home to attend college. The youth In our report appeared to have managed well. Glucose control in our subjects remained similar, as reported previOU.S~Y for adults who switched to pen injectors {2,7,8), and there were no episodes of ketoacidosis or of severe hypoglycemia in the study or control groups. The main benefit expected was improvement in &%A:
