| NCT ID | NCT04039763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-09-03 |
| Primary Completion | 2022-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2020-09-03 with a primary completion date of 2022-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Shivani Misra
PRINCIPAL INVESTIGATOR
Imperial College Healthcare NHS Trust
Frequently Asked Questions
Who can join the NCT04039763 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 25 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04039763 currently recruiting?
Yes, NCT04039763 is actively recruiting participants. Contact the research team at s.misra@nhs.net for enrollment information.
Where is the NCT04039763 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT04039763 clinical trial?
NCT04039763 is sponsored by Imperial College London. The principal investigator is Shivani Misra at Imperial College Healthcare NHS Trust. The trial plans to enroll 20 participants.
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