Determining the amount of time with low glucose in people using premixed (biphasic) insulin
| ISRCTN | ISRCTN10603608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10603608 |
| Secondary identifying numbers | ADC-UK-PMS-19040 |
- Submission date
- 03/05/2019
- Registration date
- 22/05/2019
- Last edited
- 01/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background & study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this pilot study is to collect glucose data using the FreeStyle Libre Pro Flash Glucose Monitoring System from adults with type 2 diabetes using pre-mixed (biphasic) insulin.
Who can participate?
Patients aged 18 and over with type 2 diabetes using pre-mixed (biphasic) insulin and an HbA1c less than 7.5% (58 mmol/mol).
What does the study involve?
Participants will wear two Sensors for up to 14 days (glucose data is not visible during this time). Participants will return to the clinic for Visit 2 where the Sensors will be removed, and data uploaded.
What are the possible benefits & risks of participating?
There is no direct benefit to the participant by taking part in this study. 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 support future pivotal clinical study designs in this population.
Where is the study run from?
1. Royal Derby Hospital, Derby
2. Royal Berkshire Hospital, Reading
3. Royal Blackburn Hospital, Blackburn
4. Ninewells Hospital, Dundee
5. Royal Infirmary of Edinburgh, Edinburgh
6. Hathaway Medical Centre, Chippenham
7. Kiltearn Medical Centre, Nantwich
8. Ashfields Primary Care Centre, Sandbach
9. Claremont Medial Practice, Exmouth
10. Albany House Medical Centre, Wellingborough
11. Eynsham Medical Group, Eynsham
12. The Adam Practice, Hamworthy
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
Pamela.Reid@abbott.com
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 in both hospital and GP practice settings. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-arm pilot study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available. |
| Scientific title | Pilot study to determine Time in HYpoglycaemia when using pre-MixEd (biphasic) insulin |
| Study acronym | THYME |
| Study objectives | This pilot study is being conducted to determine the amount of time spent in low glucose or hypoglycaemia (less than 3.9 mmol/L [70 mg/dL]) by people with type 2 diabetes when using pre-mixed (biphasic) insulin. |
| 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; 0207 104 8048; nrescommittee.southwest-cornwall-plymouth@nhs.net), ref: 19/SW/0086. |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | Participants will wear two FreeStyle Libre Pro Flash Glucose Monitoring Sensors for up to 14 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) | |
| Primary outcome measure | Time in hypoglycaemia (<3.9 mmol/L [70 mg/dL]), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration. |
| 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 two-week study duration. |
| Overall study start date | 01/01/2019 |
| Completion date | 07/08/2019 |
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. Type 2 diabetes treated with pre-mixed (biphasic) insulin for at least 6 months prior to study enrolment. 3. Most recent HbA1c less than 7.5% (58 mmol/mol), recorded in medical notes in last 12 months. |
| Key exclusion criteria | 1. Currently prescribed animal insulin. 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 | 24/07/2019 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
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 | Yes |
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | 17/09/2021 | 01/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/07/2022: Publication 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 24/07/2019.
2. The overall trial end date was changed from 31/07/2019 to 07/08/2019.
3. The total final enrolment was added.
21/05/2019: Trial's existence confirmed by the South West - Cornwall & Plymouth Research Ethics Committee.
