To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes.

A 2:1 open randomised controlled feasibility trial.

Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi.

45 people living with type 1 diabetes (PLWT1D).

Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education.

Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life.

Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention.

This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge.

PACTR202102832069874.

The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi.

We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach.

First-level hospitals in Neno district, Malawi.

Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers.

Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management.

Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings.

PACTR202102832069874; Post-results.