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Flexible Intensive Versus Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes

An open-label, randomized, controlled, crossover clinical trial of metabolic control and patient preference

¹ Department of Internal Medicine III, Friedrich-Schiller-University, Jena, Germany
² Industrie und Handelskammer (Chamber of Commerce) Thuringia, Erfurt, Germany
³ Bethanien-Hospital, Heidelberg, Germany
⁴ Hospital-Fulda, Fulda, Germany

Address correspondence and reprint requests to Christof Kloos, MD, Klinik für Innere Medizin, Erlanger Allee 101, Friedrich-Schiller-Universität, 07740 Jena, Germany. E-mail: christof.kloos@med.uni-jena.de

Abbreviations: CIT, conventional insulin therapy • FIT, flexible intensive insulin therapy

The first 20% of the full text of this article appears below.

	INTRODUCTION

 
Improving metabolic control can reduce complications in type 2 diabetes (1–4). Conventional insulin therapy (CIT) and flexible intensive insulin therapy (FIT) are treatment options in insulin-dependent type 2 diabetic patients. In CIT, participants inject premixed human insulin (30% regular insulin, 70% NPH insulin) before breakfast and dinner and follow individually adjusted diet plans with fixed amounts of carbohydrates (5). In FIT, human regular insulin is adjusted before main meals according to current blood glucose readings and desired carbohydrate intake. When necessary, NPH insulin is added at bedtime. CIT can be easy to handle and requires less active diabetes self-management. In FIT, patients benefit from dietary freedom and improvement in quality of life (6). In pilot studies, FIT has shown good metabolic control and low risk of hypoglycemia (7). FIT may have additional advantages due to better postprandial blood glucose control (8).

	RESEARCH DESIGN AND METHODS—

 
We tested the hypothesis that FIT and CIT in insulin-naive adults with type 2 diabetes are equally effective in regard to metabolic outcomes. We hypothesized that younger participants, in employment, would prefer FIT.

The trial was designed as a clinical, prospective, randomized, open-label, single-center, crossover study. The primary end point was glycosylated hemoglobin A_1c (GHb); secondary end points were mild and severe hypoglycemia, insulin dosage, blood pressure, BMI, and therapy preference. Participants started insulin therapy either with CIT (group A) or FIT (group B), randomly. Individual insulin dosage and . . . [Full Text of this Article]

	RESULTS—

 

	CONCLUSIONS—

 

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