Effectiveness of “Rule of Seven” intervention in improving control status in diabetes mellitus protocol of a randomized controlled trial

Abstract

BACKGROUND: We developed the “rule of seven” intervention because different targets related to diabetes control can somehow be calculated by multiplication of seven. This study aimed to evaluate the effectiveness of the “rule of seven” in improving glycemic control in patients diagnosed with diabetes by measuring fasting plasma glucose and 2 hours postprandial plasma glucose. MATERIALS AND METHODS: This two-arm randomized controlled trial will compare the effectiveness of the “rule of seven” intervention in achieving glycemic control in diabetes mellitus patients. The patients in the control arm will receive routine patient counseling related to diabetes mellitus. Patients registered with the noncommunicable disease (NCD) clinics of All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Community Health Center (CHC) Tangi, and CHC Mendhasala will be recruited consecutively during clinic hours after fulfilling eligibility criteria and obtaining written informed consent. The sample size was estimated as 426 in each group. The ethical permission was obtained from the Institutional Ethics Committee (IEC) and prospectively registered in the Clinical Trial Registry of India (CTRI/2023/07/055522). DISCUSSION: After the intervention, we will find out the change in knowledge regarding parameters related to glycemic status; discover the change in biochemical parameters after 1, 3, and 6 months; and conclude whether those changes are statistically significant or not.