RT-CGM in Young Adults at Risk of DKA (YODA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glucose Metabolism Disorders; Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetes Mellitus, Type 1; Metabolic Disease
• Intervention / Treatment: Device: Dexcom G6; Device: Self monitoring of blood glucose

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shivani Misra; Phone Number: 02075946136; Email: s.misra@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Imperial College Clinical Research Facility
    • Contact: Shivani Misra, MBBS, MRCP; Phone Number: 0207 594 6136; Email: s.misra@nhs.net
    • Principal Investigator: Shivani Misra, MBBS, MRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Dexcom G6; Realtime Continous Glucose Monitoring
Placebo Comparator: Standard care; Standard care - finger prick self monitoring of blood glucose.	Device: Self monitoring of blood glucose; Finger prick self monitoring of blood glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycated haeomglobin (HbA1c)	Change over intervention period or standard care (control) period, with each participant acting as their own control	Over 6 months for intervention period and over 6 months for control period (total 12 months)

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Shivani Misra, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Type 1 Diabetes Mellitus
• Additional Relevant MeSH Terms: Immune System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Autoimmune Diseases; Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: 19SM5161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes