How Common is Hypoglycaemia in Older People With Diabetes Who Fall?

NCT05470842 | Completed Results FDA Device

• 1 other identifier: v2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use 24 hour continuous glucose monitoring in older patients with diabetes who present with symptoms of falls, or dizziness, or confusion, that may indicate hypoglycaemia.

Conditions

Diabetes; Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Captured Hypoglycaemia

  Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period.

  10 days

Secondary Outcomes (2)

• Overall Time in Range (Average)

  10 days

• Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days

  30 days

Other Outcomes (1)

• For Participants Who Experienced Hypoglycaemic Events, the Amount of Time (Minutes) They Were in the Hypoglycaemic Range

  10 days

Study Arms (1)

Continuous glucose monitoring

EXPERIMENTAL

Continuous Glucose Monitoring Device for up to 10 days

Device: Continuous glucose monitoring (Dexcom G6)

Interventions

Continuous glucose monitoring (Dexcom G6) DEVICE

All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.

Also known as: Dexcom G6

Continuous glucose monitoring

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years and older with diabetes
• Treated with glucose-medications which carry a high risk of hypoglycaemia (sulfonylureas and/or insulin)
• Presenting to hospital with a fall and/or symptoms suggestive of unrecognised hypoglycaemia (such as dizziness, feeling muddled).

You may not qualify if:

• Treatment with metformin alone
• Lack of capacity,
• Not willing to participate,
• Terminal illness (less than one-year life expectancy).
• Evidence of bruising, bleeding, cellulitis and/or skin tears on the upper arms or abdomen.

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Dr Katharina Mattishent
• Organization: UNiversity of East Anglia

k.mattishent@uea.ac.uk

01603286286

Study Officials

• Katharina Mattishent, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, single arm study

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: June 6, 2023
• Primary Completion: September 22, 2023
• Study Completion: October 31, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)