Combining novel self-monitoring technologies for persuasive behaviour change in people at moderate or high risk of developing Type 2 diabetes

The Sensing Interstitial Glucose to Nudge Active Lifestyles (SIGNAL) Study: Combining novel self-monitoring technologies for persuasive behaviour change in people at moderate or high risk of developing Type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17545949

Enrollment

Registered

2017-05-15

Start date

2017-05-18

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes Nutritional, Metabolic, Endocrine Prediabetes

Interventions

Following enrolment, participants’ baseline physical activity will be measured for one week using two devices, an ActiGraph GT3x-BT and a Fitbit Charge 2. No feedback will be provided during free-livi

providing feedback) and a physical activity monitor (Fitbit

not providing feedback) for four weeks. Group 2: Participants will receive a Freestyle Libre (not providing feedback) and Fitbit (providing feedback) for four weeks. Following this, participants in g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. At least 40 years of age 2. Own a compatible Android smartphone [Version 4.3+ with access to internet, Bluetooth and near infrared communication (NFC))] 3. Have a moderate or high risk of developing Type 2 diabetes (score =16 points on a validated Type 2 diabetes screening survey)

Exclusion criteria

Exclusion criteria: 1. Have a clinical diagnosis of Type 1 or Type 2 diabetes or a HbA1c reading of >6.4% 2. Unable/unwilling to provide informed consent 3. Unable/unwilling to adhere to the study protocol 4. Unable to understand written/verbal English 5. Pregnant (suspected or confirmed)

Design outcomes

Primary

Measure	Time frame
Device engagement will be assessed by: 1. Time spent on the official LibreLink application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks 2. Time spent on the official Fitbit application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks 3. The number of Freestyle Libre scans using LibreLinkUp application at 1, 2, 3, 4, 5, and 6 weeks 4. The number of user-driven Fitbit syncs using Fitabase at 1, 2, 3, 4, 5, and 6 weeks 5. Semi-structured interviews at 6 weeks	—

Measure

Time frame

Device engagement will be assessed by: 1. Time spent on the official LibreLink application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks 2. Time spent on the official Fitbit application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks 3. The number of Freestyle Libre scans using LibreLinkUp application at 1, 2, 3, 4, 5, and 6 weeks 4. The number of user-driven Fitbit syncs using Fitabase at 1, 2, 3, 4, 5, and 6 weeks 5. Semi-structured interviews at 6 weeks

—

Secondary

Measure	Time frame
1. Feasibility of delivering the intervention is measured using semi-structured interviews, researcher notes, Ethica Data, Fitabase, Diasend, LibreLinkUp at 1, 2, 3, 4, 5, and 6 weeks 2. Physical activity is measured using Fitbit Charge 2 at baseline and 1, 2, 3, 4, 5, and 6 weeks 3. Interstitial glucose levels are measured using Freestyle Libre at 1, 2, 3, 4, 5, and 6 weeks 4. Eligibility, uptake and retention is measured using researcher notes at baseline, 1, 2, 3, 4, 5, and 6 weeks 5. Changes in technology readiness is measured using the Technology Readiness Index 2.0 at baseline and 6 weeks 6. Health literacy is measured using the eHealth Literacy Scale at baseline and 6 weeks 7. Health status is measured using the 5Q-5D-5L at baseline and 6 weeks 8. Attitude about health is measured using the Risk Perception Survey – Developing Diabetes at baseline and 6 weeks	—

Measure

Time frame

1. Feasibility of delivering the intervention is measured using semi-structured interviews, researcher notes, Ethica Data, Fitabase, Diasend, LibreLinkUp at 1, 2, 3, 4, 5, and 6 weeks 2. Physical activity is measured using Fitbit Charge 2 at baseline and 1, 2, 3, 4, 5, and 6 weeks 3. Interstitial glucose levels are measured using Freestyle Libre at 1, 2, 3, 4, 5, and 6 weeks 4. Eligibility, uptake and retention is measured using researcher notes at baseline, 1, 2, 3, 4, 5, and 6 weeks 5. Changes in technology readiness is measured using the Technology Readiness Index 2.0 at baseline and 6 weeks 6. Health literacy is measured using the eHealth Literacy Scale at baseline and 6 weeks 7. Health status is measured using the 5Q-5D-5L at baseline and 6 weeks 8. Attitude about health is measured using the Risk Perception Survey – Developing Diabetes at baseline and 6 weeks

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026