CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
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A comparison of glycaemic variability in CSII vs. MDI treated type 1 diabetic patients using CGMS.

OBJECTIVE: To evaluate and compare glucose variability, hypoglycaemic events and daily glycaemic control in well-controlled (HbA1c <or= 7%), type 1 diabetic patients treated with either continuous subcutaneous insulin infusion (CSII) using lispro or multiple daily insulin injection (MDI) using glargine once daily and lispro with meals.

RESEARCH DESIGN AND METHODS: A total of 16 patients with type 1 diabetes receiving treatment with either CSII (eight patients) or MDI (eight patients), all with HbA1c levels < 7%, wore a continuous glucose monitoring system sensor for 3 days to compare the number, duration, timing and severity of hyperglycaemic and hypoglycaemic episodes.

RESULTS: There were several more episodes of hyperglycaemic [blood glucose (BG) >or= 180 mg/dl] and hypoglycaemic (BG <or= 60 mg/dl) excursions observed in patients treated with CSII than MDI. Glycaemic exposure over 150 mg/dl was similar between the two groups. Maintenance of near-euglycaemia as determined by the average amount of time spent within the glucose range of 80-140 mg/dl was marginally significantly better for the MDI than for the CSII group. Although the CSII group had significantly more hypoglycaemic episodes below 60 mg/dl, the average duration of hypoglycaemia was not significantly different for the two groups. Similar percentages of nocturnal hypoglycaemia were seen. There were no reported major adverse events throughout the duration of the study.

CONCLUSION: Well-controlled type 1 diabetic patients treated with MDI had fewer hyperglycaemic and hypoglycaemic excursions than patients treated with CSII.

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