RecruitingNot ApplicableNCT04039763

RT-CGM in Young Adults at Risk of DKA

Assessment of the Impact of Real-time Continuous Glucose Monitoring on Glycaemic Control in High-risk Adolescents and Young Adults With Insulin-treated Diabetes


Sponsor

Imperial College London

Enrollment

20 participants

Start Date

Sep 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 25 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

Interventions

DEVICEDexcom G6

Realtime Continous Glucose Monitoring

DEVICESelf monitoring of blood glucose

Finger prick self monitoring of blood glucose


Locations(1)

Imperial College Clinical Research Facility

London, United Kingdom

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NCT04039763


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