A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes

William H. Herman, Liza L. Ilag, Susan L. Johnson, Catherine L. Martin, Joyce Sinding, Abdulaziz Al Harthi, Cynthia D. Plunkett, Frankie B. LaPorte, Ray Burke, Morton B. Brown, Jeffery B. Halter, Philip Raskin

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Abstract

OBJECTIVE- To compare the efficacy and safety of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life. RESEARCH DESIGN AND METHODS- Adults (n = 107) ≥60 years of age (mean age 66 years) with insulin-treated type 2 diabetes (mean duration 16 years, BMI 32 kg/m2, and HbA1C-[A1C] 8.2%) were randomized 10 CSII (using insulin lispro) or MDI (using insulin lispro and insulin glargine) in a two-center, 12-month, prospective, randomized, controlled clinical trial. Efficacy was assessed with A1C, safely by frequency of hypoglycemia, and treatment satisfaction and quality of Life with the Diabetes Quality of Life Clinical Trial Questionnaire and the 36-item short-form health survey, version 2. RESULTS- Forty-eight CSII subjects (91%) and 50 MDI subjects (93%) completed the study. Mean A1C fell by 1.7 ± 1.0% in the CSII group to 6.6% and by 1.6 ± 1.2% in the MDI group to 6.4%. The difference in A1C between treatment groups was not statistically significant (P = 0.20). Eighty-one percent of CSII subjects and 90% of MDI subjects experienced at least one episode of minor (self-treated) hypoglycemia (P = 0.17), and three CSII and six MDI subjects experienced severe hypoglycemia (P = 0.49). Rates of severe hypoglycemia were similarly low in the two groups (CSII 0.08 and MDI 0.23 events per person-year, P = 0.61). Weight gain did not differ between groups (P = 0.70). Treatment satisfaction improved significantly with both CSII and MDI (P < 0.0001), and the difference between groups was not statistically significant (P = 0.58). CONCLUSIONS- In older subjects with insulin-treated type 2 diabetes, both CSII and MDI achieved excellent glycemic control with good safety and patient satisfaction.

Original languageEnglish (US)
Pages (from-to)1568-1573
Number of pages6
JournalDiabetes Care
Volume28
Issue number7
DOIs
StatePublished - Jul 2005

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Subcutaneous Infusions
Type 2 Diabetes Mellitus
Clinical Trials
Insulin
Injections
Hypoglycemia
Insulin Lispro
Quality of Life
Safety
Therapeutics
Health Surveys
Patient Satisfaction
Weight Gain
Research Design
Randomized Controlled Trials

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

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A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. / Herman, William H.; Ilag, Liza L.; Johnson, Susan L.; Martin, Catherine L.; Sinding, Joyce; Al Harthi, Abdulaziz; Plunkett, Cynthia D.; LaPorte, Frankie B.; Burke, Ray; Brown, Morton B.; Halter, Jeffery B.; Raskin, Philip.

In: Diabetes Care, Vol. 28, No. 7, 07.2005, p. 1568-1573.

Research output: Contribution to journalArticle

Herman, WH, Ilag, LL, Johnson, SL, Martin, CL, Sinding, J, Al Harthi, A, Plunkett, CD, LaPorte, FB, Burke, R, Brown, MB, Halter, JB & Raskin, P 2005, 'A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes', Diabetes Care, vol. 28, no. 7, pp. 1568-1573. https://doi.org/10.2337/diacare.28.7.1568
Herman, William H. ; Ilag, Liza L. ; Johnson, Susan L. ; Martin, Catherine L. ; Sinding, Joyce ; Al Harthi, Abdulaziz ; Plunkett, Cynthia D. ; LaPorte, Frankie B. ; Burke, Ray ; Brown, Morton B. ; Halter, Jeffery B. ; Raskin, Philip. / A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. In: Diabetes Care. 2005 ; Vol. 28, No. 7. pp. 1568-1573.
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abstract = "OBJECTIVE- To compare the efficacy and safety of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life. RESEARCH DESIGN AND METHODS- Adults (n = 107) ≥60 years of age (mean age 66 years) with insulin-treated type 2 diabetes (mean duration 16 years, BMI 32 kg/m2, and HbA1C-[A1C] 8.2{\%}) were randomized 10 CSII (using insulin lispro) or MDI (using insulin lispro and insulin glargine) in a two-center, 12-month, prospective, randomized, controlled clinical trial. Efficacy was assessed with A1C, safely by frequency of hypoglycemia, and treatment satisfaction and quality of Life with the Diabetes Quality of Life Clinical Trial Questionnaire and the 36-item short-form health survey, version 2. RESULTS- Forty-eight CSII subjects (91{\%}) and 50 MDI subjects (93{\%}) completed the study. Mean A1C fell by 1.7 ± 1.0{\%} in the CSII group to 6.6{\%} and by 1.6 ± 1.2{\%} in the MDI group to 6.4{\%}. The difference in A1C between treatment groups was not statistically significant (P = 0.20). Eighty-one percent of CSII subjects and 90{\%} of MDI subjects experienced at least one episode of minor (self-treated) hypoglycemia (P = 0.17), and three CSII and six MDI subjects experienced severe hypoglycemia (P = 0.49). Rates of severe hypoglycemia were similarly low in the two groups (CSII 0.08 and MDI 0.23 events per person-year, P = 0.61). Weight gain did not differ between groups (P = 0.70). Treatment satisfaction improved significantly with both CSII and MDI (P < 0.0001), and the difference between groups was not statistically significant (P = 0.58). CONCLUSIONS- In older subjects with insulin-treated type 2 diabetes, both CSII and MDI achieved excellent glycemic control with good safety and patient satisfaction.",
author = "Herman, {William H.} and Ilag, {Liza L.} and Johnson, {Susan L.} and Martin, {Catherine L.} and Joyce Sinding and {Al Harthi}, Abdulaziz and Plunkett, {Cynthia D.} and LaPorte, {Frankie B.} and Ray Burke and Brown, {Morton B.} and Halter, {Jeffery B.} and Philip Raskin",
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T1 - A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes

AU - Herman, William H.

AU - Ilag, Liza L.

AU - Johnson, Susan L.

AU - Martin, Catherine L.

AU - Sinding, Joyce

AU - Al Harthi, Abdulaziz

AU - Plunkett, Cynthia D.

AU - LaPorte, Frankie B.

AU - Burke, Ray

AU - Brown, Morton B.

AU - Halter, Jeffery B.

AU - Raskin, Philip

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N2 - OBJECTIVE- To compare the efficacy and safety of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life. RESEARCH DESIGN AND METHODS- Adults (n = 107) ≥60 years of age (mean age 66 years) with insulin-treated type 2 diabetes (mean duration 16 years, BMI 32 kg/m2, and HbA1C-[A1C] 8.2%) were randomized 10 CSII (using insulin lispro) or MDI (using insulin lispro and insulin glargine) in a two-center, 12-month, prospective, randomized, controlled clinical trial. Efficacy was assessed with A1C, safely by frequency of hypoglycemia, and treatment satisfaction and quality of Life with the Diabetes Quality of Life Clinical Trial Questionnaire and the 36-item short-form health survey, version 2. RESULTS- Forty-eight CSII subjects (91%) and 50 MDI subjects (93%) completed the study. Mean A1C fell by 1.7 ± 1.0% in the CSII group to 6.6% and by 1.6 ± 1.2% in the MDI group to 6.4%. The difference in A1C between treatment groups was not statistically significant (P = 0.20). Eighty-one percent of CSII subjects and 90% of MDI subjects experienced at least one episode of minor (self-treated) hypoglycemia (P = 0.17), and three CSII and six MDI subjects experienced severe hypoglycemia (P = 0.49). Rates of severe hypoglycemia were similarly low in the two groups (CSII 0.08 and MDI 0.23 events per person-year, P = 0.61). Weight gain did not differ between groups (P = 0.70). Treatment satisfaction improved significantly with both CSII and MDI (P < 0.0001), and the difference between groups was not statistically significant (P = 0.58). CONCLUSIONS- In older subjects with insulin-treated type 2 diabetes, both CSII and MDI achieved excellent glycemic control with good safety and patient satisfaction.

AB - OBJECTIVE- To compare the efficacy and safety of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life. RESEARCH DESIGN AND METHODS- Adults (n = 107) ≥60 years of age (mean age 66 years) with insulin-treated type 2 diabetes (mean duration 16 years, BMI 32 kg/m2, and HbA1C-[A1C] 8.2%) were randomized 10 CSII (using insulin lispro) or MDI (using insulin lispro and insulin glargine) in a two-center, 12-month, prospective, randomized, controlled clinical trial. Efficacy was assessed with A1C, safely by frequency of hypoglycemia, and treatment satisfaction and quality of Life with the Diabetes Quality of Life Clinical Trial Questionnaire and the 36-item short-form health survey, version 2. RESULTS- Forty-eight CSII subjects (91%) and 50 MDI subjects (93%) completed the study. Mean A1C fell by 1.7 ± 1.0% in the CSII group to 6.6% and by 1.6 ± 1.2% in the MDI group to 6.4%. The difference in A1C between treatment groups was not statistically significant (P = 0.20). Eighty-one percent of CSII subjects and 90% of MDI subjects experienced at least one episode of minor (self-treated) hypoglycemia (P = 0.17), and three CSII and six MDI subjects experienced severe hypoglycemia (P = 0.49). Rates of severe hypoglycemia were similarly low in the two groups (CSII 0.08 and MDI 0.23 events per person-year, P = 0.61). Weight gain did not differ between groups (P = 0.70). Treatment satisfaction improved significantly with both CSII and MDI (P < 0.0001), and the difference between groups was not statistically significant (P = 0.58). CONCLUSIONS- In older subjects with insulin-treated type 2 diabetes, both CSII and MDI achieved excellent glycemic control with good safety and patient satisfaction.

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