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RT-CGM in Young Adults at Risk of DKA

Sponsor: Imperial College London

NCT ID: NCT04039763

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Dexcom G6 (device), Self monitoring of blood glucose (device)
How long the study runs
Study runs about 21 months (dates as stated)
About the drug or intervention
Dexcom G6 — device: Realtime Continous Glucose Monitoring · Self monitoring of blood glucose — device: Finger prick self monitoring of blood glucose
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 25 Years
Who
All
Number of participants
20
Started
2020-09-03
Last checked
2022-06

Plain English Summary

What is this study?

  • • Testing a new treatment for diabetes mellitus
  • • NA - 20 participants
  • • Pilot study to evaluate the effect of real time continuous glucose monitoring (RT-CGM) on young-adults with insulin-treated diabetes, who are defined as high risk due to suboptimal HbA1c (blood glucose control) or a history of hospital admissions for high blood glucoses

Who can take part?

  • • Ages 18 Years to 25 Years
  • • Diagnosed with diabetes mellitus

Where?

  • • London - Imperial College Clinical Research Facility

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Pilot study to evaluate the effect of real time continuous glucose monitoring (RT-CGM) on young-adults with insulin-treated diabetes, who are defined as high risk due to suboptimal HbA1c (blood glucose control) or a history of hospital admissions for high blood glucoses. Hypothesis: RT-CGM provided to young adults with suboptimal blood glucose control, has a beneficial impact on HbA1c and hospital admissions for high blood glucoses. We will use data from this pilot work to inform a larger powered study to address this knowledge gap.

More detail

Real time continous glucose monitoring (RT-CGM) is a technology that measures people's sugar level all the time, using a sensor that is placed on the skin. The sensor can be worn for 10 days and the small transmitter clicks into the sensor and sends the glucose readings wirelessly to a smartphone or a small handset, which displays the glucose level on the screen. It also has alarms to tell people when their sugar level is too high or too low. This study uses the Dexcom G6 RT-CGM system. RT-CGM devices have become smaller and can connect easily with mobile phones. We want to find out whether young people, in particular, find the technology useful and whether it improves how they self-managed their diabetes over a 6-month period. This is a randomised controlled cross over trial; participants are randomly assigned to the control group (standard care which is self-monitoring of blood glucose via fingerprick) or the intervention group (RT-CGM) for the first 6 months and then cross over for the 2nd 6 months. Participants will be able to share their CGM data if they wish via Dexcom Clarity with the research/clinical team, who will support them in making treatment decisions in light of the data. All participants will be asked to take part in a semi-structured interview with a Diabetes Specialist Clinical Psychologist at baseline, including to address some of the barriers to self-management and a further interview at the end of the 6 months during which they use RT- CGM, to explore their experiences using it. All participants will be asked to complete validated psychology questionnaires at baseline, 6 months and 12 months. A blood test for HbA1C will be done at baseline, 6 months and 12 months. After 12 months, all participants will be invited to attend a focus group to provide feedback \& share their experiences of using RT-CGM and raise themes brought up in psychology interviews to the whole group.

Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersMetabolic DiseaseAutoimmune DiseasesEndocrine System Diseases

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 25 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Adolescents and young adults aged 18-25 years
  • ✓Insulin-treated diabetes \>12 months (on multiple daily injections or insulin pump therapy)
  • ✓HbA1c \> 75 mmol/mol (9%) or 1 or more DKA admissions in the last 12 months or 1 or more admissions with...
  • ✓Naïve to RT-CGM - except for short periods for use for diagnosis or monitoring purposes.
  • ✓Use of prior flash glucose monitoring is permittable

Who cannot take part

  • ✗Chronic kidney disease eGFR \<30ml/min
  • ✗Pregnant or planning pregnancy
  • ✗Breastfeeding
  • ✗Have active cancer or under investigation for cancer
  • ✗Severe visual impairment
See the full criteria
Inclusion Criteria: * Adolescents and young adults aged 18-25 years * Insulin-treated diabetes \>12 months (on multiple daily injections or insulin pump therapy) * HbA1c \> 75 mmol/mol (9%) or 1 or more DKA admissions in the last 12 months or 1 or more admissions with uncontrolled blood glucose levels in the last 12 months. * Naïve to RT-CGM - except for short periods for use for diagnosis or monitoring purposes. * Use of prior flash glucose monitoring is permittable Exclusion Criteria: * Chronic kidney disease eGFR \<30ml/min * Pregnant or planning pregnancy * Breastfeeding * Have active malignancy or under investigation for malignancy * Severe visual impairment * Reduced manual dexterity * Unable to participate due to other factors, as assessed by the Chief Investigator

Where Is This Study? (1 UK site)

Imperial College Clinical Research Facility

London, United Kingdom

Recruiting
Site contact (verified)
Shivani Misra, MBBS, MRCPPrincipal Investigator
Shivani Misra, MBBS, MRCP0207 594 6136s.misra@nhs.net

How to Get in Touch

Shivani Misra

Sponsor contact

CONTACT

02075946136 s.misra@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2022-06