A Clinical Trial of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Older Adults With Type 2 Diabetes

Clinical Care/Education/Nutrition

¹Department of Internal Medicine and Epidemiology, University of Michigan Medical Center, Ann Arbor, Michigan
²Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, Michigan
³Department of Biomedical Research, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
⁴Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan

Address correspondence and reprint requests to William H. Herman, MD, MPH, University of Michigan Health System, 1500 East Medical Center Dr., 3920 Taubman Center, Ann Arbor, MI 48109-0354. E-mail: wherman{at}umich.edu

Diabetes Care 2005 Jul; 28(7): 1568-1573. https://doi.org/10.2337/diacare.28.7.1568

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Figure 1—
Study recruitment and retention.
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Figure 2—
Mean A1C by treatment group and time. Data are means ± SD.

Table 1—

Characteristics of the study population

	CSII	MDI
Subjects randomized (n)	53	54
Age (years)	66.6 ± 5.9	66.2 ± 4.5
Sex (male)	38 (72)	24 (44)
Race
Caucasian	43 (81)	49 (91)
Black	4 (8)	2 (4)
Hispanic	4 (8)	2 (4)
Other	2 (4)	1 (2)
Duration of diabetes (years)	16.9 ± 9.0	15.4 ± 8.9
Prior diabetes treatment
Insulin only	30 (57)	33 (61)
Insulin and oral agent(s)	23 (43)	21 (39)
Prior insulin treatment (years)	8.1 ± 8.3	8.2 ± 7.7
History of diabetes complications*
Retinopathy	20 (42)	19 (36)
Nephropathy	9 (17)	7 (13)
Neuropathy	37 (72)	32 (59)
History of cardiovascular complications*
Hypertension	38 (72)	41 (76)
Dyslipidemia	31 (58)	41 (76)
Cigarette smoking (current)	2 (4)	3 (6)
Angina/myocardial infarction/heart failure	24 (45)	17 (32)
BMI (kg/m²)	32.5 ± 5.8	31.8 ± 5.8
A1C (%)	8.4 ± 1.1	8.1 ± 1.2

Table 2—

Injection or infusion site problems and treatment-specific technical or mechanical problems reported by subjects

	CSII (n = 51)			MDI (n = 54)		P
		Events	Subjects	Events	Subjects	P
Injection and infusion site problems*
Infection	5	5 (10)	0	0 (0)	0.20
Irritation/inflammation	85	36 (69)	15	10 (19)	<0.01
Bleeding/bruising	50	26 (50)	180	47 (87)	<0.01
Any site problem	122	42 (82)	188	48 (89)	0.41
Technical and mechanical problems
Device malfunction (infusion pump or insulin pen)	20	17 (33)	9	7 (13)
Improper or inadequate insulin delivery	10	10 (20)	3	2 (4)
Difficulty with pump setup or operation	25	15 (28)	—	—
Concern about pen accuracy	—	—	2	2 (4)
Difficult to depress pen plunger	—	—	5	4 (7)
Difficult to see units on pen	—	—	4	4 (7)
Problem type not specified	16	14 (27)	5	5 (9)
Any technical or mechanical problem	72	39 (76)	28	22 (41)

Data are n (%). Events reported at time of routine study visits. All visits subsequent to treatment initiation are included. P values are for difference in numbers of subjects reporting problems.
*
↵* P values were calculated for injection/infusion site problems only. Treatment specificity of technical and mechanical problems precluded direct comparison of groups.