Evidence map›Paper›PMID 34900846›Full record

ArticleJournal of diabetes and metabolic disorders2021

Study protocol: Safety and efficacy of smart watch integrated do-it-yourself continuous glucose monitoring in adults with Type 1 diabetes, a randomised controlled trial.

Shekhar Sehgal, Martin De Bock, Jonathan Williman, Barry Taylor, Mona Elbalshy, Barbara Galland, Rosemary Hall, Ryan Paul, Alisa Boucsein, Shirley Jones and 2 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of diabetes and metabolic disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% of its field
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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
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

12 authors at 4 institutions in 1 country.

Shekhar SehgalDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.ORCID 0000-0002-2764-9980
Martin De BockDepartment of Paediatrics, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140 New Zealand.
Jonathan WillimanDepartment of Paediatrics, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140 New Zealand.
Barry TaylorDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.
Mona ElbalshyDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.
Barbara GallandDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.
Rosemary HallDepartment of Endocrinology and Diabetes, Capital and Coast District Health Board, Wellington, New Zealand.
Ryan PaulWaikato Medical Research Centre, University of Waikato, Hamilton, New Zealand.
Alisa BoucseinDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.
Shirley JonesDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.
Carla FrewenDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.
Benjamin J WheelerDepartment of Women's and Children's Health, Dunedin School of Medicine, Otago Medical School, University of Otago, PO Box 56, Dunedin, New Zealand.
University of Otago · NZCapital and Coast District Health Board · NZSouthern District Health Board · NZUniversity of Waikato · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeType 1 diabetes (T1D) management requires regular monitoring of glucose levels and judicious therapeutic administration of insulin to prevent both microvascular and macrovascular complications. Few people with diabetes are able to sustain the self-monitored blood glucose measurements needed for optimal care, and those that do, typically experience significant diabetes-related distress. Both intermittently scanned continuous glucose monitoring (isCGM) and continuous glucose monitoring (CGM) offer alternatives to reduce the overall burden, but both still have limitations. Given the expense of CGM, smart watch integrated do-it-yourself (DIY)-CGM has been developed as an alternative to commercial isCGM and CGM technologies. This study has been designed to evaluate the clinical efficacy of smart watch integrated DIY-CGM compared with isCGM in adults with T1D.

methodsThis multicentre, randomised, crossover study will be conducted in New Zealand and aims to recruit 60 adults with established T1D who currently use isCGM. DIY-CGM will be compared to usual care with isCGM. Participants will be randomised to either arm of the study for 8 weeks followed by a 4-week washout period before crossing over to the other study arm for a further 8 weeks. The primary endpoint is glucose time in range (TIR) defined as percentage of time interstitial glucose is spent between 3.9 to 10 mmol/L for the entire intervention period. Secondary endpoints include diabetes-related quality of life, distress, and sleep quality in participants and their partners. DISCUSSION: The results of this study will provide clinical trial data regarding smart watch integrated DIY-CGM versus isCGM for improving glycaemic control in adults with T1D, and also report a variety of key secondary outcomes, including changes in subjective outcome measures for both people with diabetes and their partners.

trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12621000648820,31 May 2021); World Health Organisation International Clinical Trial Registry Platform (U1111-1262-2784, 3

Indexed as

Continuous glucose monitoringDiabetes-related distressHypoglycaemiaIntermittently scanned continuous glucose monitoringMiao MiaoType 1 diabetes

Identifiers

PMID34900846
PMCPMC8630291
OpenAlexW3210649173

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.