Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy

Diabetes Technology and Therapeutics

Volumn 10, Issue 6, 2008, Pages 461-466

  Peyrot, Mark ^a,b   Rubin, Richard R ^b   Polonsky, William H ^c  

^a LOYOLA UNIVERSITY MARYLAND   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLITAZONE DERIVATIVE; GLUCOSE; HEMOGLOBIN A1C; INSULIN GLARGINE; METFORMIN; PLACEBO; PRAMLINTIDE; SULFONYLUREA;

ADD ON THERAPY; ADULT; AGED; ARTICLE; BODY WEIGHT; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES DISTRESS; DISEASE ASSOCIATION; DISTRESS SYNDROME; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; EMOTION; FEMALE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN RELATION; HYPOGLYCEMIA; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE REGRESSION; NON INSULIN DEPENDENT DIABETES MELLITUS; PHYSICIAN; POSTPRANDIAL STATE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; TREATMENT OUTCOME; WEIGHT REDUCTION;

AGED; AMYLOID; BODY MASS INDEX; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; INTERPERSONAL RELATIONS; MALE; MIDDLE AGED; REGRESSION ANALYSIS; STRESS, PSYCHOLOGICAL;

EID: 57349178109     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2008.0031     Document Type: Article

References (25)

1. Fisher L, Skaff MM, Mullan JT, Arean P, Mohr D, Masharani U, Glasgow R, Laurencin G: Clinical depression versus distress among patients with type 2 diabetes: not just a question of semantics. Diabetes Care 2007;30:542-548.
2. Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA: Assessing psychosocial distress in diabetes: development of the Diabetes Distress Scale. Diabetes Care 2005;28:626-631.
3. Snoek FJ, Pouwer F, Welch GW, Polonsky WH: Diabetes-related emotional distress in Dutch and U.S. diabetic patients: cross-cultural validity of the Problem Areas in Diabetes scale. Diabetes Care 2000;23:1305-1309.
4. Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE: Assessment of diabetes-related distress. Diabetes Care 1995;18:754-760.
5. Glasgow RE, Fisher L, Skaff M, Mullan J, Toobert DJ: Problem solving and diabetes self-management: investigation in a large, multiracial sample. Diabetes Care 2007;30:33-37.
6. Food and Drug Administration: Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development and Labeling Claims. http://www.fda.gov/CDER/GUIDANCE/5460dft.pdf (accessed March 24, 2008).
7. Marra G; DIAB. & TE.S Study Group: The DIAB.&TE.S Project: how patients perceive diabetes and diabetes therapy. Acta Biomed 2004;75:164-170.
8. Kong MF, Stubbs TA, King P, Macdonald IA, Lambourne JE, Blackshaw PE, Perkins AC, Tattersall RB: The effect of single doses of pramlintide on gastric emptying of two meals in men with IDDM. Diabetologia 1998;41:577-583.
9. Fineman MS, Koda JE, Shen LZ, Strobel SA, Maggs DG, Weyer C, Kolterman OG: The human amylin analog, pramlintide, corrects postprandial hyperglucagonemia in patients with type 1 diabetes. Metabolism 2002;51:636-641.
10. Chapman I, Parker B, Doran S, Feinle-Bisset C, Wishart J, Strobel S, Wang Y, Burns C, Lush C, Weyer C, Horowitz M: Effect of pramlintide on satiety and food intake in obese subjects and subjects with type 2 diabetes. Diabetologia 2005;48:838-848.
11. Edelman S, Garg S, Frias J, Maggs DG, Wang Y, Zhang B, Strobel S, Lutz K, Kolterman O: A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Diabetes Care 2006;29:2189-2195.
12. Hollander PA, Levy P, Fineman MS, Maggs DG, Shen LZ, Strobel SA, Weyer C, Kolterman OG: Pramlintide therapy as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 2003;26:784-790.
13. Marrero DG, Crean J, Zhang B, Kellmeyer T, Gloster M, Herrmann K, Rubin RR, Fineberg N, Kolterman O: Effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes. Diabetes Care 2007;30:210-216.
14. SYMLIN [package insert]. San Diego, CA: Amylin Pharmaceuticals, 2005.
15. Whitehouse F, Kruger DF, Fineman MS, Shen L, Ruggles JA, Maggs DG, Weyer C, Kolterman OG: A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes. Diabetes Care 2002;25:724-730.
16. Ratner RE, Dickey R, Fineman MS, Maggs DG, Strobel SA, Weyer C, Kolterman OG: Amylin replacement with pramlintide as adjunct to insulin therapy improves long-term glycemic and weight control in type 1 diabetes mellitus: a one-year randomized controlled trial. Diabet Med 2004;21:1204-1212.
17. Riddle M, Frias J, Zhang B, Maier H, Brown C, Lutz K, Kolterman O: Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care 2007;30:2794-2799.
18. Cohen J: Statistical Power Analysis for the Behavioral Sciences. London: Academic Press, 1969.
19. Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-592.
20. Peyrot M: Causal modeling: theory and applications. J Pediatr Psychol 1996;21:3-24.
21. Snoek FJ, Skovlund SE, Pouwer F: Development and validation of the Insulin Treatment Appraisal Scale (ITAS) in patients with type 2 diabetes. Health Quality Life Outcomes 2007;5:69 [Epub at http://www.hqlo.com/content/5/1/ 69, doi:10.1186/1477-7525-5-69].
22. Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV: Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care 2005;28:2543-2545.
23. Rubin RR, Peyrot M: Assessing treatment satisfaction in patients treated with pramlintide as an adjunct to insulin therapy. Curr Med Res Opin 2007;23:1919-1929.
24. Peyrot M, Rubin RR: Behavioral and psychosocial interventions in diabetes: a conceptual review. Diabetes Care 2007;30:2433-2440.
25. Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH: Development of a brief diabetes distress screening instrument. Ann Family Med 2008;6:246-252.