RT-CGM in Young Adults at Risk of DKA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorImperial College London

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Chronic kidney disease eGFR <30ml/min

Pregnant or planning pregnancy

Breastfeeding

Have active malignancy or under investigation for malignancy

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dexcom G6

    Device

    Realtime Continous Glucose Monitoring

  • Self monitoring of blood glucose

    Device

    Finger prick self monitoring of blood glucose

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Real Time Continuous Glucose MonitoringExperimental treatment 1 intervention
Group B: Standard carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in glycated haeomglobin (HbA1c)

Change over intervention period or standard care (control) period, with each participant acting as their own control

Time frame
Over 6 months for intervention period and over 6 months for control period (total 12 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

DexCom, Inc.

Collaborator