Evidence map›Paper›PMID 38719319›Full record

Trial reportBMJ open2024

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial.

Apoorva Gomber, Francis Valeta, Matthew M Coates, Celina Trujillo, Gina Ferrari, Medson Boti, Kenwood Kumwenda, Bright Mailosi, Dester Nakotwa, Laura Drown and 10 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Apoorva GomberCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-9955-9917
Francis ValetaPartners In Health, Neno, Malawi.
Matthew M CoatesCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Celina TrujilloCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Gina FerrariCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Medson BotiPartners In Health, Neno, Malawi.
Kenwood KumwendaPartners In Health, Neno, Malawi.
Bright MailosiPartners In Health, Neno, Malawi.
Dester NakotwaPartners In Health, Neno, Malawi.
Laura DrownCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Emily B WroeCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Ada ThapaCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Victor MithiPartners In Health, Neno, Malawi.
Beatrice MatanjePartners In Health, Neno, Malawi.
Amos MsekandianaKamuzu Central Hospital, Lilongwe, Malawi.
Paul H ParkCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Chiyembekezo KachimangaPartners In Health, Neno, Malawi.
Gene BukhmanCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Todd RudermanPartners In Health, Neno, Malawi.
Alma J AdlerCenter for Integration Science, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA aadler2@bwh.harvard.edu.ORCID 0000-0002-6700-3279

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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.

designA 2:1 open randomised controlled feasibility trial.

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

participants45 people living with type 1 diabetes (PLWT1D).

interventionsParticipants 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. OUTCOMES: 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.

resultsParticipants 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.

conclusionsThis 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. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Indexed as

Continuous Glucose MonitoringDiabetes Mellitus, Type 1AdultBlood GlucoseFeasibility StudiesFemaleGlycated HemoglobinHospitals, DistrictHumansMalawiMaleMiddle AgedQuality of LifeRural PopulationBlood GlucoseGlycated HemoglobinDIABETES & ENDOCRINOLOGYGeneral diabetesInternational health services

Identifiers

PMID38719319
PMCPMC11086545

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.