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Open Access Highly Accessed Study protocol

Effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes: design of the IN CONTROL-trial

Uriëll L Malanda12*, Sandra DM Bot123, Piet J Kostense13, Frank J Snoek14, Jacqueline M Dekker13 and Giel Nijpels12

Author Affiliations

1 EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands

2 Department of General Practice, VU University Medical Centre, Amsterdam, the Netherlands

3 Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, the Netherlands

4 Department of Medical Psychology, VU University Medical Centre, Amsterdam, the Netherlands

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BMC Family Practice 2009, 10:26  doi:10.1186/1471-2296-10-26

Published: 27 April 2009

Abstract

Background

Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM). Possibly, offering direct feedback on diabetes management may diminish the presence of diabetes specific emotional problems and might enhance the patients' belief they are able to manage their illness. It is hypothesized that self-monitoring of glucose in combination with an algorithm how and when to act will motivate T2DM patients to become more active participants in their own care leading to a decrease in diabetes related distress and an increased self-efficacy.

Methods and design

Six hundred patients with T2DM (45 ≤ 75 years) who receive care in a structured diabetes care system, HbA1c ≥ 7.0%, and not using insulin will be recruited and randomized into 3 groups; Self-monitoring of Blood Glucose (SMBG), Self-monitoring of Urine Glucose (SMUG) and usual care (n = 200 per group). Participants are eligible if they have a known disease duration of over 1 year and have used SMBG or SMUG less than 3 times in the previous year. All 3 groups will receive standardized diabetes care. The intervention groups will receive additional instructions on how to perform self-monitoring of glucose and how to interpret the results. Main outcome measures are changes in diabetes specific emotional distress and self-efficacy. Secondary outcome measures include difference in HbA1c, patient satisfaction, occurrence of hypoglycaemia, physical activity, costs of direct and indirect healthcare and changes in illness beliefs.

Discussion

The IN CONTROL-trial is designed to explore whether feedback from self-monitoring of glucose in T2DM patients who do not require insulin can affect diabetes specific emotional distress and increase self-efficacy. Based on the self-regulation model it is hypothesized that glucose self-monitoring feedback changes illness perceptions, guiding the patient to reduce emotional responses to experienced threats, and influences the patients ability to perform and maintain self-management skills.

Trial registration

Current Controlled Trials ISRCTN84568563