An exploratory study evaluating the measurement of non-glycaemic parameters as markers of impending or present hypoglycaemia in people with Type 1 Diabetes.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000327583
• Date of registration: 09/04/2015
• Prospective Registration: Yes
• Primary sponsor: St Vincents Hospital Melbourne
• Public title: An exploratory study evaluating the measurement of non-glycaemic parameters as markers of impending or present hypoglycaemia in people with Type 1 Diabetes.
• Scientific title: An exploratory study evaluating the measurement of non-glycaemic parameters as markers of impending or present hypoglycaemia in people with Type 1 Diabetes.
• Date of first enrolment: 13/04/2015
• Target sample size: 80
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000327583.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;

Countries of recruitment

Australia

Contacts

• Name: Dr Sybil McAuley

• Name: Dr Sybil McAuley

Key inclusion & exclusion criteria

Inclusion criteria: -Type 1 Diabetes
-HbA1c <9.0%
-Participant willing to comply with study protocol

Exclusion criteria: -Diabetic ketoacidosis within the past 4 weeks
-Pregnant or planned pregnancy during the study period
-Dermatological conditions involving the region of glucose sensor insertion
-Participant on beta-blocker therapy

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Type 1 Diabetes;
Type 1 Diabetes

Intervention(s)

This study aims to obtain overnight exploratory data regarding the relationship of non-glycaemic parameters (such as wrist and finger tremor and temperature to hypoglycaemia) in Type 1 Diabetes participants. This study intends to evaluate the accuracy of a non-invasive device designed to detect these early signs of hypoglycaemia.

The Investigational Device (ID) consists of a wrist band connected by a flexible wire to a ring. Participants will wear the ID overnight placed on the wrist and middle finger of the non-dominant hand prior to retiring to bed. The ID will be removed after the participant wakes in the morning. Parameters including wrist and finger tremor and temperature will be monitored continuously by the ID during wear.

Following baseline assessment, participants will be provided with education regarding the ID. Participants will be instructed to undertake reference capillary blood glucose measurements (a minimum of 4 times a day over the 2 week study period) and to wear Continuous Glucose Monitoring (CGM) sensors for the two-week study duration.

During the study, the participants will also be instructed to keep a diary documenting activity, diet, capillary glucose reading, insulin, and hypogylcaemic episodes.

Participants will attend the Clinical Trials Centre (CTC) on Day 8 to have the CGM sensor changed. On Day 15, participants will attend the CTC for collection of the study devices and diary.

Primary Outcome(s)

Correlation of temperature at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.[Monitored every 5 minutes overnight over the 2 week study period. ]

Correlation of tremor at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.[Monitored every 5 minutes overnight over the 2 week study period. ]

Secondary Outcome(s)

Correlation of difference in temperature at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds. [Monitored every 5 minutes overnight over the 2 week study period. ]

Participant acceptance regarding comfort and utility of the device.[Assessed via an interview on Day 15.]

Correlation of difference in temperature at wrist and finger measured by the ID with CGM rate of change in glucose.[Monitored every 5 minutes overnight over the 2 week study period. ]

Correlation of tremor at wrist and finger measured by the ID with CGM rate of change in glucose.[Monitored every 5 minutes overnight over the 2 week study period. ]

A comparison of the parameters (tremor, temperature) and rate of change in these parameters measured by the ID with confirmatory finger-prick blood-glucose meter readings above and below hypoglycaemia thresholds. [Done during symptoms of hypoglycaemia over the 2 week study period. ]

Correlation of temperature at wrist and finger measured by the ID with CGM rate of change in glucose.[Monitored every 5 minutes overnight over the 2 week study period. ]

Differences and similarities noted in the above associations described above comparing hypoglycaemia aware vs. hypoglycaemia unaware participants, as per Gold Score for hypogylcaemia unawareness.[Monitored every 5 minutes overnight over the 2 week study period. ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Firefly Health Pty Ltd

Secondary Sponsor(s)

Baker IDI Heart and Diabetes Institute

Ethics review

Status: Approved
Approval date:
Contact:

St Vincent's Hospital Melbourne