RT-CGM in Young Adults at Risk of DKA

NCT04039763 | Recruiting

• 1 other identifier: 19SM5161
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Disease; Autoimmune Diseases; Endocrine System Diseases

Keywords

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Real Time Continuous Glucose Monitoring

EXPERIMENTAL

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

Standard care

PLACEBO COMPARATOR

Standard care - finger prick self monitoring of blood glucose.

Device: Self monitoring of blood glucose

Interventions

Dexcom G6 DEVICE

Realtime Continous Glucose Monitoring

Real Time Continuous Glucose Monitoring

Self monitoring of blood glucose DEVICE

Finger prick self monitoring of blood glucose

Standard care

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Imperial College Clinical Research Facility

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Autoimmune Diseases; Endocrine System Diseases

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Shivani Misra

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivani Misra

CONTACT

02075946136; s.misra@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled crossover study

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: July 31, 2019
• Study Start: September 3, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)