abstract | 295

P-1433 ≥7.5% and ≤12.0% on at least 2 oral antihyperglycemic drugs (OAD)

were assigned to prestudy OADs plus dinnertime insulin lispro mix 50
tight blood glucose control in t1DM via continuously adjusted
(LM50) (50% insulin lispro/50% insulin lispro protamine suspension)
insulin delivery based on frequent blood glucose sampling
or morning insulin glargine (G). Injections were added (1-2 more in
A.G. Gallardo-Hernandez1, S.A. Islas-Andrade2, M.C. Revilla-Monslave2, LM50, 1-3 lispro in G+L) to achieve premeal BG 4.4-5.6 mmol/L.
L. Fridman1, Y. Shtessel3, R. Leder1 The primary objective was to show noninferiority in HbA1c change
1
Universidad Nacional Autónoma de México, Posgrado de Ingeniería, from baseline (upper limit of the 95% CI of treatment difference in
Mexico DF, Mexico HbA1c [LM50 group minus insulin glargine+lispro (G+L) <0.3%]).
2
Centro Médico Nacional Siglo XX, Unidad de investigación en The Expectations About Insulin Therapy Questionnaire (EAITQ)
enfermedades metabólicas, Mexico DF, Mexico was administered at Week 0; Experiences With Insulin Therapy
3
The University of Alabama in Huntsville, Electrical and Computer Questionnaire (EWITQ) at Week 36. Questionnaires consisted of 15
Engineering Department, Huntsville Al, USA corresponding items (insulin therapy and insulin delivery system)
summarized into positive, negative and self-efficacy subscales.
aims: Classical T1DM therapy includes three or more blood glucose
results: Baseline HbA1c was similar (LM50 9.3; G+L 9.2%; p=.11).
concentration measurements daily and a similar number of insulin
The majority of pts (286/469~61%) were on >1 injection at study end
injections. Nevertheless, the most important factors for treatment
(median=2 in both groups). Between-group difference in HbA1c change
success are patients’ nutritional habits and their acceptance of and
from baseline to endpoint was 0.17% (95% CI -0.03 to 0.37), not
adherence to the treatment. Even in the best of cases hypoglycemia
meeting pre-specified noninferiority criteria. No difference was seen in
episodes can occur. An automatic insulin pump improves therapy
endpoint HbA1c (LM50 7.7; G+L 7.5%, p=.1). Overall hypoglycemia
results, but a risk of hypoglycemia still exists.
rates (adjusted for 30 days) were similar except at endpoint (LM50 1.6;
Method: This research is focused on closed-loop insulin pump therapy
G+L 2.2, p=.02). The main devices used were HumaPen Luxura (87%)
for T1DM. It includes on line blood glucose (BG) information from a
(LM50) and OptiClik, OptiSet, OptiPen Pro 1 or Optipens (82%)
glucose sensor. The approach is to design a mathematical algorithm
(G+L). No EAITQ between–group differences were noted.
able to determinate the short term insulin requirement using High
Order Sliding Mode control. This technique does not require as input Table: EWITQ Subscale Negative Positive Self-efficacy
any of the patient parameters, such as insulin resistance or glucose
effectiveness. It means that is possible to design a universal insulin LM50 G+L p-value
n Mean±sD n Mean±sD (aNoVa)
delivery controller that is suitable for every patient.
results: A preliminary test of the controller was conducted with 227 2.4±1.3 225 2.6±1.3 .15

three different mathematical models to generate in silico patients (SP); 227 6.2±0.8 225 6.0±0.9 .02

the Bergman Minimal Model, the Hovorka Model, and the Sorensen 227 5.8±1.0 225 5.8±0.9 .58

Model. For each model three different SP are simulated with insulin
EWITQ items showing between-group differences in overall 7-category
resistance 5.5±5 min-1per mU/l. This study simulations lasted 400
rating for LM50 vs G+L were: Taking insulin makes me feel better (79%
minutes, with initial conditions for BG of 130mg/dl. At minute 100,
vs 88% slightly to strongly agree, p=.04); My insulin delivery system
meal ingestion is simulated, and postprandial BG is 180±25 mg/dl. BG
is physically painful (77% vs 70% slightly to strongly disagree, p<.01);
for every patient is under 110mg/dl at minute 300, after minute 350
My insulin delivery system is easy for me to use away from home (87%
all SP reach the BG target of 90mg/dl.
vs 76% slightly to strongly agree, p=.01); My insulin delivery system
Discussion/conclusion: This type of designed controller can be used
is convenient (93% vs 86% slightly to strongly agree, p=.01); It’s easy
for any patient, due to the fact that it is not designed for any specific
to get the dose I need with my insulin delivery system (93% vs 89%
parameter set or mathematical model. The success of this therapy
slightly to strongly agree, p=.04).
depends on an accurate BG sensor and the only input to the controller
conclusions: HbA1c was reduced from baseline with LM50 and G+L
is BG level which reduces the risk of hypoglycemia. The sensors
but noninferiority in HbA1c was not met. EWITQ scores suggest that
available are able to measure BG every 10 seconds. In the simulations,
LM50 pts may have had a more favorable experience with their insulin
pump dynamics and sensor sample rate are considered in order to have
therapy that was associated with the insulin delivery system.
an implementable system for a trail in a clinical setting.
Insulin therapy and devices
Insulin therapy and devices
Conflict of interest
No conflict of interest
Stock ownership: Liza L. Ilag, Xuejing Mao, Margaret Campbell, and
Clarice Hayes are stockholders of Eli Lilly and Company. Employee:
P-1434
Liza L. Ilag, Xuejing Mao, Margaret Campbell, and Clarice Hayes are
Expectations and experiences with insulin therapy employees of Eli Lilly and Company.
in the prandial-basal insulin regimens to improve
mealtime glycaemia in type 2 diabetes study P-1437
L. Ilag , X. Mao , M. Campbell , C. Hayes
1 2 3 4
average daily dose of analog basal insulins in patients
1
Lilly Research Laboratories, Insulins/Devices Medical, Indianapolis with type 2 diabetes: a matched case control analysis
Indiana, USA
C. McAdam-Marx1, J. Yu1, V. Shankar2, J. Bouchard3, M. Aagren3,
2
Lilly Research Laboratories, Humalog & Insulin Devices, Indianapolis
D.I. Brixner1
Indiana, USA 1
University of Utah, Department of Pharmacotherapy, Salt Lake City,
3
Lilly Research Laboratories, Diabetes/Endocrine, Indianapolis Indiana,
USA
USA 2
SDI Health LLC, Verispan, Plymouth Meeting, USA
4
Lilly Research Laboratories, Epidemiology/Health Srvc Research, 3
NovoNordisk Inc, Health Economics & Outcomes Research, Princeton,
Indianapolis Indiana, USA
USA
aims: Knowledge of patients (pts)’ expectations and experiences with
aims: Insulin is a recommended treatment option in patients with
insulin therapy may help inform clinical practices on insulin initiation
type 2 diabetes (T2D) who fail to maintain glycemic control on oral
and intensification.
antidiabetic drugs. Insulin dose is patient specific and driven by blood
Materials and methods: In this 36-wk, parallel group, international
glucose control. The purpose of this study was to compare the average
RCT, adult pts with type 2 diabetes, no insulin for ≥90 days, HbA1c