Performance of an Electronic Diary System for Intensive Insulin Management in Global Diabetes Clinical Trials

Diabetes Technology and Therapeutics

Volumn 17, Issue 8, 2015, Pages 571-579

  Bastyr, Edward J ^a,b   Zhang, Shuyu ^a   Mou, Jiani ^a   Hackett, Andy P ^c   Raymond, Stephen A ^c   Chang, Annette M ^a  

^a ELI LILLY AND COMPANY   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c PHT Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN GLARGINE; INSULIN LISPRO; INSULIN PEGLISPRO; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; LONG ACTING INSULIN;

ARTICLE; CONTROLLED STUDY; DIABETES MELLITUS; DIABETIC PATIENT; ELECTRONIC MEDICAL RECORD; FEMALE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRESCRIPTION; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; RANDOMIZED CONTROLLED TRIAL; ADULT; AGED; ANALYSIS; BLOOD; BLOOD GLUCOSE MONITORING; DEVICES; DIET RESTRICTION; ELECTRONIC PRESCRIBING; EVALUATION STUDY; MIDDLE AGED; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS AND NUMERICAL DATA; TELEMETRY; TIME FACTOR;

ADULT; AGED; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS; ELECTRONIC PRESCRIBING; FASTING; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN GLARGINE; INSULIN LISPRO; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TELEMETRY; TIME FACTORS;

EID: 84938561571     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2014.0407     Document Type: Article

References (15)

1. Klonoff DC: The current status of mHealth for diabetes: will it be the next big thing? J Diabetes Sci Technol 2013;7:749-758.
2. Jhaveri M, Lee E: Performance of electronic diaries in diabetes clinical trials measured through overall satisfaction of site coordinators. J Diabetes Sci Technol 2007;1: 522-530.
3. Cavanaugh K, Huizinga MM, Wallston KA, et al.: Association of numeracy and diabetes control. Ann Intern Med 2008;148:737-746.
4. Nam S, Chesla C, Stotts NA, et al.: Barriers to diabetes management: patient and provider factors. Diabetes Res Clin Pract 2011;93:1-9.
5. Mazze RS, Shamoon H, Pasmantier R, et al.: Reliability of blood glucose monitoring by patients with diabetes mellitus. Am J Med 1984;77:211-217.
6. Heller S, Koenen C, Bode B: Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, openlabel, parallel-group, treat-to-target noninferiority trial. Clin Ther 2009;31:2086-2097.
7. Hollander P, Cooper J, Bregnhoj J, et al.: A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther 2008;30: 1976-1987.
8. DeVries JH, Snoek FJ, Kostense PJ, et al.: Improved glycaemic control in type 1 diabetes patients following participation per se in a clinical trial-mechanisms and implications. Diabetes Metab Res Rev 2003;19:357-362.
9. Lehmann ED. Simulating glycosylated hemoglobin (HbA1c) levels in diabetes using an interactive educational virtual diabetes patient simulator. Diabetes Technol Ther 2001;3: 517-524.
10. Rodbard D: Hypo-and hyperglycemia in relation to the mean, standard deviation, coefficient of variation, and nature of the glucose distribution. Diabetes Technol Ther 2012;14:868-876.
11. Kovatchev B, Cobelli C, Renard E, et al.: Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of the results. J Diabetes Sci Technol 2010;4:1374-1381.
12. Russell SJ, El-Khatib FH, Sinha M, et al.: Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med 2014;371:313-325.
13. Campion TR Jr, May AK, Waitman LR, et al.: Characteristics and effects of nurse dosing over-rides on computerbased intensive insulin therapy protocol performance. J Am Med Inform Assoc 2011;18:251-258.
14. Cramer JA, Pugh MJ: The influence of insulin use on glycemic control: how well do adults follow prescriptions for insulin? Diabetes Care 2005;28:78-83.
15. Donnelly LA, Morris AD, Evans JM: Adherence to insulin and its association with glycaemic control in patients with type 2 diabetes. QJM 2007;100:345-350.