Determining variation in glucose levels in people with impaired glucose tolerance (prediabetes)
| ISRCTN | ISRCTN15304729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15304729 |
| Secondary identifying numbers | ADC-UK-PMS-19041 |
- Submission date
- 03/05/2019
- Registration date
- 22/05/2019
- Last edited
- 10/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background & study aims
The number of people with diabetes continues to rise throughout the world. In addition, there has been a similar rise in impaired glucose tolerance or prediabetes, which is a risk factor for developing type 2 diabetes. The aim of this pilot study is to collect glucose data using the FreeStyle Libre Pro Flash Glucose Monitoring System from adults with impaired glucose tolerance.
Who can participate?
Patients aged 18 and over with an HbA1c of 5.7-6.4% (39-47 mmol/mol).
What does the study involve?
Participants will wear two FreeStyle Libre Pro Sensors for up to 14 days (glucose data is not visible during this time). Participants will also be supplied with a fitness tracker and a tablet; an app will be pre-installed on the tablet and participants will be requested to record dietary intake for three days.
Participants will return to clinic for Sensor removal and data upload (Sensor and tracker), they will then wear a FreeStyle Libre Sensor for up to 14 days (glucose data will be visible during this time). Participants will be requested to complete a questionnaire at the end of the study.
What are the possible benefits & risks of participating?
The study gives participants with impaired glucose tolerance the opportunity to experience sensor technology using the FreeStyle Libre Pro and FreeStyle Libre Systems. The only risks associated with the study are from obtaining venous blood samples, these are small but could include pain, bruising, local infection and fainting. Data collected may be used to inform future pivotal clinical study designs in this population.
Where is the study run from?
1. Hathaway Medical Centre, Chippenham
2. Claremont Medial Practice, Exmouth
3. Albany House Medical Centre, Wellingborough
4. The Adam Practice, Hamworthy
5. Atherstone Surgery, Atherstone
When is the study starting and how long is it expected to run for?
28/05/2019 to 31/07/2019
Who is funding the study?
The study is funded by Abbott Diabetes Care Ltd
Who is the main contact?
Dr Pamela Reid
Contact information
Public
Abbott Diabetes Care
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 1993 863024 |
|---|---|
| Pamela.Reid@abbott.com |
Study information
| Study design | Prospective multi-centre single-arm pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-arm pilot study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | A pilot study to determine glycaemic variability in people with impaired glucose tolerance (prediabetes) |
| Study acronym | SAGE |
| Study objectives | This pilot study is being conducted to determine the amount of glycaemic variability (measured by %CV glucose) in people with impaired glucose tolerance (prediabetes). |
| Ethics approval(s) | Approved 17/05/2019, NRES Committee: South West – Cornwall and Plymouth Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0)207 104 8048; nrescommittee.southwest-cornwall-plymouth@nhs.net), ref: 19/SW/0087 |
| Health condition(s) or problem(s) studied | Impaired glucose tolerance |
| Intervention | Participants will wear two FreeStyle Libre Pro Flash Glucose Monitoring Sensors for up to 14 days, followed by FreeStyle Libre for up to 14 days. During the Libre Pro sensor wear, participants will wear a fitness tracker (throughout the two weeks) and record dietary intake (for three days). There is no follow-up period unless the participant experiences an unanticipated adverse device effect (ADE). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre Pro Flash Glucose Monitoring Sensor, FreeStyle Libre |
| Primary outcome measure | Glycaemic variability (%CV glucose), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the first two-weeks of the study. |
| Secondary outcome measures | Other glycaemic measures such as time in range (3.9-10.0 mmol/L [70-180 mg/dL]), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the first two-weeks of the study. |
| Overall study start date | 01/01/2019 |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 43 |
| Key inclusion criteria | 1. Aged 18 years or over. 2. Most recent HbA1c 5.7-6.4% (39-47 mmol/mol), recorded in medical notes in last 12 months. |
| Key exclusion criteria | 1. Recorded diagnosis of diabetes. 2. Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition. 3. Has a pacemaker or any other neurostimulators. 4. Currently receiving dialysis treatment or planning to receive dialysis during the study. 5. Women who are pregnant, plan to become pregnant or become pregnant during the study. 6. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management. 7. Known (or suspected) allergy to medical grade adhesives. 8. In the investigator’s opinion, unsuitable to participate due to any other cause/reason. |
| Date of first enrolment | 28/05/2019 |
| Date of final enrolment | 27/07/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 1993 863164 |
|---|---|
| Joe.Bugler@abbott.com | |
"ROR" |
https://ror.org/03wnay029 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Possible presentation at a diabetes conference, and/or publication in a peer-reviewed journal. Estimated timeline is one year from trial end date. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Pamela Reid. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/06/2020 | 01/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Abstract results | 25/08/2020 | 10/06/2024 | No | No |
Editorial Notes
10/06/2024: Abstract reference added.
01/07/2022: Abstract reference added.
16/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/07/2019 to 27/07/2019.
2. The overall trial end date was changed from 31/07/2019 to 31/08/2019.
3. The total final enrolment was added.
22/05/2019: Trial's existence confirmed by the South West - Cornwall & Plymouth Research Ethics Committee.
