Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial
Abstract
Introduction As many people with type 1 diabetes find it hard to reach the recommended glycemic goals, even with CGM, this study aims to determine if a closer, digitally supported collaboration on interpreting CGM data together with a diabetes nurse can improve glycemic control. Methods and analysis A total of 120 individuals, 18 years and older and with HbA1c ≥ 58 mmol/mol will be included in the study at 8 different sites in Sweden and Norway. To be included, the participants must use a CGM or isCGM and be able to upload the data to the appropriate online service for their clinic and sensor. Both those with insulin pumps and insulin pens will be included in the study. Participants will be randomized into two different groups, that is, the intensive therapy group and the control group. The intensive therapy group will upload their glucose data weekly for the first 4 months and have telephone contact with their diabetes care team to receive support in interpreting CGM data and taking appropriate actions if their mean blood glucose level is above 8.4 mmol/L. After the 4-month-long intensive treatment phase, both randomized groups will have the same number of clinical visits and receive the same type of diabetes support. Discussion It is of great importance to find new ways to help people with type 1 diabetes manage their condition as well as they can to help them achieve better glycemic control so that hopefully more people can achieve the recommended glycemic goals, which…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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