Diabetes SelfManagement Profile Revised for Conventional and Flexible

Diabetes Self-Management Profile. Revised for Conventional and Flexible Insulin Regimens Wysocki, T. 1, Xing, D. 2, Fiallo-Scharer, R. 3, Doyle, E. 4, Block, J. 5, Tsalikian, E. 6, Beck, R. 2, Ruedy, K. 2, Kollman, C. 2, Harris, M. 7, Tamborlane, W. 4, and the Diabetes Research in Children Network (Direc. Net) Study Group. 1 Jacksonville, FL; 2 Tampa, FL; 3 Denver, CO; 4 New Haven CT; 5 Stanford, CA; 6 Iowa City, IA; 7 St. Louis, MO.

Abstract The Diabetes Self Management Profile (DSMP) is a validated interview assessing five areas of diabetes self-management: Exercise; Hypoglycemia; Diet; Blood Glucose Testing; and Insulin. As part of a Direc. Net outpatient study, we tested two 25 -item forms of the DSMP as measures of diabetes self management behavior in youth with T 1 DM on conventional and flexible (i. e. using carbohydrate counting) insulin regimens. Two trained interviewers administered the appropriate DSMP form by telephone to 192 7 -17 yr old youth and parents upon entry into in a 5 -center study. Parents and youth <11 yrs of age (n=61) were interviewed together. Parents and youth ≥ 11 yrs old (n=131) were interviewed separately. Hemoglobin A 1 c (A 1 c) was measured in a central laboratory using HPLC. Internal consistency (Cronbach's alpha coefficient) of parent responses for the DSMP Total was 0. 62 (Conventional) and 0. 69 (Flexible). Spearman correlation was 0. 32 (p<0. 001) between the DSMP Blood Glucose Testing score and meter-verified test frequency. Parents' DSMP total scores declined with increasing age (p<0. 001). Spearman correlation between parent and adolescent total scores was 0. 58, and ranged from 0. 42 -0. 72 for the subscales (p<0. 001 in each case). Mean DSMP total score did not differ significantly between youth (62. 4 ± 7. 4) and parents (61. 3 ± 8. 4), but the mean difference increased with A 1 c: 0. 1 ± 7. 4; 1. 0 ± 6. 8 and 4. 3 ± 5. 8 with A 1 c values ≤ 7. 5%, 7. 6 -9. 0% and >9%, respectively (p=0. 05). The revised DSMP for youth on either Conventional or Flexible regimens have acceptable psychometric properties with adequate internal consistency and parent-adolescent agreement. Adherence scores declined with child's age. Additional psychometric properties of the DSMP and the association of parent-youth disagreement with A 1 c will be explored further in this study.

Background • The Diabetes Self-Management Profile (1 -3) is a structured interview that has been validated previously as a measure of diabetes self management behavior. • Higher scores on the DSMP indicate more meticulous diabetes self management behavior in the areas of exercise, management of hypoglycemia, diet, glucose testing and insulin administration and adjustment. • Diabetes therapy has evolved since the DSMP was developed and validated, with increasing numbers of patients treated with flexible regimens. These regimens incorporate carbohydrate counting, insulin adjustment using insulin to carbohydrate ratios, and the use of insulin pumps and so-called "basalbolus" injection regimens.

Background (continued) • Available measures of diabetes treatment adherence are typically based on measuring deviation from a structured management routine and thus are not capable of capturing problem solving and self-regulation as is expected of patients on flexible treatment regimens. • Hence, there is a need to adapt the DSMP for the assessment of self management behaviors among patients who are on such flexible regimens. • A Direc. Net outpatient study of 200 families of 7 -17 year old children with type 1 diabetes provided a context for evaluating a revised DSMP form for patients treated with flexible regimens.

Participants in the study included 200 7 -17 year-old children and adolescents with type 1 diabetes and a parent of each who were enrolled in an outpatient study being conducted by the Diabetes Research in Children Network (Direc. Net), an NIH-funded consortium that is designing and conducting evaluations of glucose-sensing technology and its clinical application.

Characteristics of Participants

Methods • Informed consent/assent signatures were obtained from each parent and child. • A Baseline evaluation was completed consisting of Hb. A 1 C, download of home glucose meters, use of a Minimed. Medtronic Continuous Glucose Monitoring System per the manufacturers' instructions, and questionnaires measuring diabetes-related anxiety and quality of life. • Two trained interviewers administered the DSMP during structured telephone interviews of parents and children together (for children < 11 years of age) and parents and adolescents separately (for children > 11 years of age). • The DSMP Flexible Regimen Form was administered if the treatment regimen included either insulin pump or basal-bolus MDI therapy and self-regulation of insulin doses based on carbohydrate counting. In all other cases, the DSMP Conventional Regimen Form was administered.

Methods (continued) • Both DSMP forms consisted of 25 questions, of which 21 are worded identically in both forms. Interview content covers Exercise (3 items); Management of Hypoglycemia (4 items); Eating (6 items); Blood Glucose Testing (8 items); and Insulin Administration & Adjustment (4 items). The maximum possible total raw score is 90 on both DSMP forms. Higher scores indicate more meticulous diabetes self-management. • The DSMP Flexible Regimen Form was administered to 117 adolescents and 161 parents; the DSMP Conventional Regimen Form was administered to 20 adolescents and 39 parents.

Figure 1 Percentage of maximum score Mean Percentage of Maximum Score on the DSMP Conventional Regimen Form (All p values = ns)

Figure 2 Percentage of maximum score Mean Percentage of Maximum Score on the DSMP Flexible Regimen Form (All p values = ns)

Results • Figures 1 and 2, respectively, show the percentage of the maximum possible scores obtained on the DSMP Conventional and Flexible Regimen Forms by parents and adolescents. • On both DSMP forms, parents' scores were slightly, but not significantly higher than those of adolescents, for the total scores as well as for each of the five subscale scores. • Internal consistency of the DSMP Total for parents was. 63 for the Conventional Form and. 69 for the Flexible Regimen Form. • Spearman rho correlation coefficients between parent and adolescent DSMP scores were as follows: Exercise (. 54); Hypoglycemia (. 72); Eating (. 54); Blood Glucose Testing (. 57); Insulin (. 42) and Total (. 56). (All p-values <. 0001).

Results (continued) • DSMP scores obtained from parents and adolescents both correlated significantly (p <. 02) with adolescents' Hb. A 1 c values. More meticulous self-management was associated with better glycemic control. • Scores on the DSMP Blood Glucose Testing subscale correlated significantly with meter-verified frequency of testing for parents (rho =. 32; p <. 001) and adolescents (rho =. 25; p <. 004). • DSMP scores of parents correlated significantly with child age (rho = -. 28; p <. 01). Adherence declined with increasing age of the child. • Figure 3 shows that mean disparity between parent and adolescent DSMP total scores increased significantly (p <. 01) with Hb. A 1 C as follows: Hb. A 1 c < 7. 5%: 0. 7 + 6. 6; Hb. A 1 c 7. 5% - 9. 0%: 0. 7 +7. 6; and Hb. A 1 c > 9. 0%: 2. 8 + 8. 1. Parentadolescent disagreement about treatment adherence was greatest among those with the poorest metabolic control.

Discussion • The revision of the DSMP into separate forms for patients treated on Conventional and Flexible Regimens yielded highly similar estimates of treatment adherence regardless of respondent (parent or adolescent) or regimen type (Conventional or Flexible). • Neither adolescents nor their parents appeared to exaggerate their adherence with the diabetes regimen since their DSMP scores indicated far less than optimal self-management. DSMP total scores of parents and adolescents indicated that adherence was no more than about 70% of maximal for both regimen types. Adolescent scores tended to indicate lower estimates of diabetes treatment adherence than did parental scores. • The profiles of DSMP subscale scores indicate consistently that adherence scores for the Blood Glucose Testing subscale were the lowest and Insulin Administration and Adjustment the highest in this sample of patients and parents.

Discussion (continued) • The reliability of the DSMP was confirmed by marginally acceptable estimates of internal consistency (alpha coefficient) and by highly significant correlations between parent and adolescent scores on the instrument. • The validity of the DSMP was supported by its significant correlations with Hb. A 1 C levels and with meter-verified frequency of blood glucose testing. • As reported in previous studies using other measures of diabetes self management, the present study also found evidence of declining adherence with increasing age of the child with diabetes. • As this prospective study of family diabetes management continues, additional analyses of the psychometric properties of the DSMP will become possible.

References 1. ) Hanson, C. L. , Henggeler, S. W. & Burghen, G. A. (1987). Social competence and parental support as mediators of the link between stress and metabolic control in adolescents with insulin-dependent diabetes mellitus. Journal of Consulting and Clinical Psychology, 55, 529 -533. 2. ) Harris, M. A. , Wysocki, T. , Sadler, M. , Wilkinson, K. , Harvey, L. M. , Buckloh, L. M. , Mauras, N. , & White, N. H. (2000). Validation of a structured interview for the assessment of diabetes self management. Diabetes Care, 23, 1301 -1304. 3. ) Harris, M. A. , Wysocki, T. , Buckloh, L. , Sadler, M. , Wilkinson, K. , & White, N. H. (2002). Psychometric properties of the Diabetes Self Management Profile: Longitudinal analysis. Diabetes, 51 (Suppl. #2), A 444 (Abstract).

Acknowledgements • The research reported here was supported by the following grants from the National Institutes of Health: HD 41890; HD 41906; HD 41908; HD 41915; HD 41918; and HD 41919. The project was also supported by the following General Clinical Research Center grants: RR 00069; RR 00059; RR 06022; and RR 00070. Additional support was provided by the Nemours Biomedical Research Program. • Michael A. Harris, Ph. D. provided consultation in the adaptation of the Diabetes Self Management Profile for measurement of self management behaviors of children and adolescents treated with flexible regimens. • Alexandra Taylor, M. A. and Amy Milkes, M. A. of Nemours Children’s Clinic performed all DSMP interviews for the study.

• Barbara Davis Center – H. Peter Chase – Rosanna Fiallo-Scharer – Jennifer Fisher – Barb Tallant • Stanford University – Bruce Buckingham – Darrell Wilson – Jennifer Block – Paula Clinton • University of Iowa – Eva Tsalikian – Michael Tansey – Linda Larson – Julie Coffey – Amy Sheehan • Yale University – William Tamborlane – Stuart Weinzimer – Elizabeth Doyle – Kristin Sikes – Amy Steffen • Nemours Children’s Clinic – Tim Wysocki – Nelly Mauras – Larry Fox – Keisha Bird – Kelly Lofton • Jaeb Center for Health Research – Roy Beck – Katrina Ruedy – Craig Kollman – Dongyuan Xing – Cynthia Silvester