Trial Outcomes & Findings for REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes (NCT NCT04916314)

NCT ID: NCT04916314

Last Updated: 2026-01-05

Results Overview

Change in participants' HbA1c from baseline to 3 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 115 participants
• Primary outcome timeframe: Baseline to 3 months
• Results posted on: 2026-01-05

Participant Flow

Participant milestones

Measure	Low Carbohydrate Diet . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Overall Study STARTED	55	60
Overall Study COMPLETED	52	59
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes

Baseline characteristics by cohort

Measure	Low Carbohydrate Diet n=55 Participants The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.	Total n=115 Participants Total of all reporting groups
Race/Ethnicity, Customized Asian	3 Participants n=9667 Participants	1 Participants n=6597 Participants	4 Participants n=16264 Participants
Age, Continuous	60.1 years STANDARD_DEVIATION 9.6 • n=9667 Participants	57.3 years STANDARD_DEVIATION 8.8 • n=6597 Participants	58.7 years STANDARD_DEVIATION 9.2 • n=16264 Participants
Race/Ethnicity, Customized White	51 Participants n=9667 Participants	58 Participants n=6597 Participants	109 Participants n=16264 Participants
Race/Ethnicity, Customized Black, mixed or other ethnicity	1 Participants n=9667 Participants	1 Participants n=6597 Participants	2 Participants n=16264 Participants
HbA1c	51.3 mmol/mol STANDARD_DEVIATION 10.2 • n=9667 Participants	57.4 mmol/mol STANDARD_DEVIATION 12.9 • n=6597 Participants	54.5 mmol/mol STANDARD_DEVIATION 12.0 • n=16264 Participants
Sex/Gender, Customized Female	31 Participants n=9667 Participants	32 Participants n=6597 Participants	63 Participants n=16264 Participants
Sex/Gender, Customized Male	23 Participants n=9667 Participants	27 Participants n=6597 Participants	50 Participants n=16264 Participants
Sex/Gender, Customized Prefer not to say	1 Participants n=9667 Participants	1 Participants n=6597 Participants	2 Participants n=16264 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Change in participants' HbA1c from baseline to 3 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change From Baseline in Participants' HbA1c	-2.3 mmol/mol Standard Deviation 7.9	-2.4 mmol/mol Standard Deviation 8.5

PRIMARY outcome

Timeframe: Baseline to 12 months

Change in participants' HbA1c from baseline to 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change From Baseline in Participants' HbA1c	0.4 mmol/mol Standard Deviation 11.9	-1 mmol/mol Standard Deviation 15.8

SECONDARY outcome

Timeframe: 1 year

Number of participants meeting consensus definition for remission from type 2 diabetes at 1 year

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Diabetes Remission at 12 Months	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months,1 year

Change in participants' weight from baseline to 3 and 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Weight Change From Baseline Weight change from baseline at 3 months	-3.6 kg Standard Deviation 3.6	-0.7 kg Standard Deviation 5.9
Weight Change From Baseline Weight change from baseline at 12 months	-2.4 kg Standard Deviation 5.3	-2.7 kg Standard Deviation 5.9

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' systolic blood pressure from baseline

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in Systolic Blood Pressure, From Baseline Systolic BP change from baseline to 3 months	-2.1 mmHg Standard Deviation 12.3	-2.9 mmHg Standard Deviation 13
Change in Systolic Blood Pressure, From Baseline Systolic BP change from baseline to 12 months	-1.6 mmHg Standard Deviation 14.2	-0.9 mmHg Standard Deviation 15.2

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' diastolic blood pressure from baseline to 3 and 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in Diastolic Blood Pressure, From Baseline Diastolic BP change from baseline to 12 months	-0.21 mmHg Standard Deviation 0.61	-0.35 mmHg Standard Deviation 0.98
Change in Diastolic Blood Pressure, From Baseline Diastolic BP change from baseline to 3 months	-2.1 mmHg Standard Deviation 9.1	-3.2 mmHg Standard Deviation 8

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' LDL cholesterol from baseline to 3 and 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in LDL Cholesterol From Baseline LDL cholesterol change from baseline to 3 months	-0.04 mmol/L Standard Deviation 0.52	-0.10 mmol/L Standard Deviation 0.49
Change in LDL Cholesterol From Baseline LDL cholesterol change from baseline to 12 months	-0.22 mmol/L Standard Deviation 0.62	0.04 mmol/L Standard Deviation 0.15

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' total cholesterol:HDL ratio from baseline to 3 and 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in Total Cholesterol:HDL Ratio From Baseline Total cholesterol:HDL ratio change from baseline to 3 months	-0.11 (ratio; no units) Standard Deviation 0.71	-0.36 (ratio; no units) Standard Deviation 0.87
Change in Total Cholesterol:HDL Ratio From Baseline Total cholesterol:HDL ratio change from baseline to 12 months	-0.35 (ratio; no units) Standard Deviation 0.67	-0.55 (ratio; no units) Standard Deviation 1.09

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' HDL cholesterol from baseline to 3 and 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in HDL Cholesterol, From Baseline HDL cholesterol change from baseline to 3 months	0.03 mmol/L Standard Deviation 0.17	0.04 mmol/L Standard Deviation 0.15
Change in HDL Cholesterol, From Baseline HDL cholesterol change from baseline to 12 months	0.07 mmol/L Standard Deviation 0.39	0.04 mmol/L Standard Deviation 0.15

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' triglycerides from baseline to 3 and 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in Triglycerides, From Baseline Triglycerides change from baseline to 3 months	-0.07 mmol/L Standard Deviation 1.03	-0.29 mmol/L Standard Deviation 1.28
Change in Triglycerides, From Baseline Triglycerides change from baseline to 12 months	-0.25 mmol/L Standard Deviation 0.86	-0.19 mmol/L Standard Deviation 1.29

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' ALT from baseline to 3 and 12 months

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in ALT From Baseline Change in ALT from baseline to 3 months	-3.3 iU/L Standard Deviation 13	-2.4 iU/L Standard Deviation 10.9
Change in ALT From Baseline Change in ALT from baseline to 12 months	-2.1 iU/L Standard Deviation 15.4	-4.1 iU/L Standard Deviation 16.6

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' PAID score from baseline to 3 and 12 months. (Minimum- maximum score; 0-100). Lower score indicating lower diabetes burden.

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in Diabetes Related Quality of Life and Distresses - Problem Areas In Diabetes (PAID) Score From Baseline Change in PAID score from baseline to 3 months	-12.3 numerical score Standard Deviation 18.1	-11.4 numerical score Standard Deviation 16.2
Change in Diabetes Related Quality of Life and Distresses - Problem Areas In Diabetes (PAID) Score From Baseline Change in PAID score from baseline to 12 months	-14.8 numerical score Standard Deviation 17.2	-10 numerical score Standard Deviation 16.5

SECONDARY outcome

Timeframe: 3 months, 1 year

Change in participants' EQ5D score from baseline to 3 and 12 months. (Score minimum-maximum is 0-1, VAS is 0-100).

Outcome measures

Measure	Low Carbohydrate Diet n=55 Participants . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.	Standard NHS Type 2 Diabetes Care n=60 Participants Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Change in Participants' EQ5D Score From Baseline Change in EQ5D-5L index value from baseline to 3 months	0.059 numerical score Standard Deviation 0.135	0.0004 numerical score Standard Deviation 0.149
Change in Participants' EQ5D Score From Baseline Change in EQ5D-5L index value from baseline to 12 months	0.041 numerical score Standard Deviation 0.152	0.001 numerical score Standard Deviation 0.014
Change in Participants' EQ5D Score From Baseline Change in EQ5D-5L VAS score from baseline to 3 months	5.2 numerical score Standard Deviation 17.6	4.0 numerical score Standard Deviation 19.7
Change in Participants' EQ5D Score From Baseline Change in EQ5D-5L VAS score from baseline to 12 months	4.5 numerical score Standard Deviation 12.2	5.9 numerical score Standard Deviation 22.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, 1 year

Data will be collected on change in dietary intake patterns (via Intake24 24 hour dietary recall questionnaire)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, 1 year

Data will be collected on measures of engagement with one of the three main components of the programme ("Learn") via the app programme

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, 1 year

Data will be collected on measures of engagement with one of the three main components of the programme ("Track") via the app programme

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, 1 year

Data will be collected on measures of engagement with one of the three main components of the programme ("Support"), via the app programme

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Interviews with participants

Outcome measures

Outcome data not reported

Adverse Events

Low Carbohydrate Diet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard NHS Type 2 Diabetes Care

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Carbohydrate Diet n=55 participants at risk . The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book. Low Carbohydrate diet: The intervention is a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), encouraging adoption of a low energy, low-carbohydrate diet, peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application; each participant additionally receives an instructional handbook, and recipe book (+/-wireless weighing and activity tracking technology).	Standard NHS Type 2 Diabetes Care n=60 participants at risk Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.
Investigations Unplanned hospital admission	1.8% 1/55 • Number of events 1 • 1 year There were no events deemed serious and related to the study procedures	16.7% 10/60 • Number of events 10 • 1 year There were no events deemed serious and related to the study procedures

Additional Information

Dr Elizabeth Morris

University of Oxford

Phone: 01865617289

Email: RESULT@phc.ox.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place