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Trial record 84 of 1734 for:    Recruiting, Not yet recruiting, Available Studies | Autoimmunity

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

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ClinicalTrials.gov Identifier: NCT04039763
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Disease Autoimmune Diseases Endocrine System Diseases Device: Dexcom G6 Device: Self monitoring of blood glucose Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised controlled crossover study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 5, 2019
Estimated Primary Completion Date : March 5, 2021
Estimated Study Completion Date : March 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

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




Primary Outcome Measures :
  1. Change in glycated haeomglobin (HbA1c) [ Time Frame: Over 6 months for intervention period and over 6 months for control period (total 12 months) ]
    Change over intervention period or standard care (control) period, with each participant acting as their own control



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039763


Contacts
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Contact: Shivani Misra 02075946136 s.misra@nhs.net

Locations
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United Kingdom
Imperial College Clinical Research Facility
London, United Kingdom
Sponsors and Collaborators
Imperial College London
DexCom, Inc.
Investigators
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Principal Investigator: Shivani Misra Imperial College Healthcare NHS Trust

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04039763     History of Changes
Other Study ID Numbers: 19SM5161
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Imperial College London:
Type 1 Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Metabolic Diseases
Glucose Metabolism Disorders
Autoimmune Diseases
Endocrine System Diseases
Immune System Diseases