Abstract
BackgroundDiabetes 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 designSix 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.DiscussionThe 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 registrationCurrent Controlled Trials ISRCTN84568563
Highlights
Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM)
This article presents a detailed description of a Randomized Controlled Trial (RCT), designed to explore the effectiveness of Self-monitoring of Blood Glucose (SMBG) and Self-monitoring of Urine Glucose (SMUG) on diabetes specific emotional distress and self-efficacy in non-insulin dependent T2DM patients
The proposed trial is sufficiently powered and, to the best of our knowledge, the first to allow for conclusions on the effect of self-monitoring of glucose on both diabetes specific emotional distress and glycaemic control in a large sample
Summary
Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM). Diabetes specific emotional problems can interfere with the strict regime type 2 diabetes mellitus (T2DM) demands. Emotional problems, such as not accepting diabetes, fear for hypoglycaemia and worrying about complications, might impact aspects of quality of life, for example, increase diabetes related distress, which in turn might affect self-care behaviours and glycaemic control [1,2]. Common self-management factors such as guidance in accepting diabetes, formulating clear and concrete goals [3] as well as personal confidence and belief in the ability to recognize, understand and act on symptoms related to T2DM may be helpful in reducing levels of distress [5]. With the self-monitoring information, lifestyle adjustments can be made, provided the patient is informed how to interpret the results and what actions to take
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