A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Aspart, Insulin Glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT01407289

ClinDiab-02

Details and patient eligibility

About

The purpose of the study is to compare the efficacy of enhanced published best practice paper-based insulin titration protocol for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay.

Enrollment: 74 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Blood glucose in the range between 140 - 400 mg/dl
• Expected stay ≥ 48 hours

Exclusion criteria

• Hyperglycemia without known history of type 2 diabetes mellitus
• Impaired renal function (serum creatinine ≥3.0mg/dL)
• Clinically relevant hepatic disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Insulin titration protocol

Experimental group

Description:

Patients in care at the Division of Endocrinology will be treated by enhanced version of published best paper based practice insulin titration protocol to control glycaemia in hospitalised patients with type 2 diabetes.

Treatment:

Drug: Insulin Aspart, Insulin Glargine

Standard care

No Intervention group

Description:

Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.