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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 25
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Imperial College Clinical Research Facility
RECRUITING
London
Contact Information
Primary
Shivani Misra
s.misra@nhs.net
02075946136
Time Frame
Start Date: 2020-09-03
Estimated Completion Date: 2022-06-30
Participants
Target number of participants: 20
Treatments
Experimental: Real Time Continuous Glucose Monitoring
Participants wear Real time continous glucose monitoring (Dexcom G6), with alarms for when their glucose is too low or too high. They will be able to view their data on the Dexcom app on their smartphones or a Dexcom receiver and share this with a nominated caregiver. Participants can chose to share data between study visits via Dexcom clarity with the research/clinical team, who will support them making changes to their insulin regime in light of the data.
Placebo_comparator: Standard care
Standard care - finger prick self monitoring of blood glucose.
Related Therapeutic Areas
Sponsors
Collaborators: DexCom, Inc.
Leads: Imperial College London

This content was sourced from clinicaltrials.gov