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

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dexcom G6
Self monitoring of blood glucose
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College Clinical Research FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Real Time Continuous Glucose Monitoring

Standard care

Arm Description

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.

Standard care - finger prick self monitoring of blood glucose.

Outcomes

Primary Outcome Measures

Change in glycated haeomglobin (HbA1c)
Change over intervention period or standard care (control) period, with each participant acting as their own control

Secondary Outcome Measures

Full Information

First Posted
July 30, 2019
Last Updated
June 23, 2022
Sponsor
Imperial College London
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04039763
Brief Title
RT-CGM in Young Adults at Risk of DKA
Acronym
YODA
Official Title
Assessment of the Impact of Real-time Continuous Glucose Monitoring on Glycaemic Control in High-risk Adolescents and Young Adults With Insulin-treated Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
DexCom, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Autoimmune Diseases, Endocrine System Diseases
Keywords
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised controlled crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real Time Continuous Glucose Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
Placebo Comparator
Arm Description
Standard care - finger prick self monitoring of blood glucose.
Intervention Type
Device
Intervention Name(s)
Dexcom G6
Intervention Description
Realtime Continous Glucose Monitoring
Intervention Type
Device
Intervention Name(s)
Self monitoring of blood glucose
Intervention Description
Finger prick self monitoring of blood glucose
Primary Outcome Measure Information:
Title
Change in glycated haeomglobin (HbA1c)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shivani Misra
Phone
02075946136
Email
s.misra@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivani Misra
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Clinical Research Facility
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivani Misra, MBBS, MRCP
Phone
0207 594 6136
Email
s.misra@nhs.net
First Name & Middle Initial & Last Name & Degree
Shivani Misra, MBBS, MRCP

12. IPD Sharing Statement

Plan to Share IPD
No

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RT-CGM in Young Adults at Risk of DKA

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