Transform Diabetes Study v1.0
Research type
Research Study
Full title
The Transform Diabetes Study: A mixed-methods study to evaluate the acceptability and potential clinical impact of a choice of dietary interventions delivered through digital group or 1 to 1 care to support weight loss and improve glycaemic control in adults with type 2 diabetes within an ethnically diverse population
IRAS ID
295915
Contact name
Lucy Jones
Contact email
Sponsor organisation
Oviva UK
Clinicaltrials.gov Identifier
NCT05648903
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
Summary of Research
The Transform Diabetes Study proposes to evaluate the acceptability and potential clinical impact of a choice of diets in adults with type 2 diabetes in a multicultural community. Participants will be allocated to receive their care either through a remote group programme or a remote 1 to 1 programme which will help us to understand if either delivery option is more effective or acceptable to patients. The aim of treatment is to achieve weight loss, improve diabetes control and in some cases put diabetes into remission (reversing their diabetes). The study plans to enrol 120 patients from five GP practices in Southwark, London. Different types of information will be collected in aim to answer these questions such as collecting information through surveys and interviews alongside assessment of clinical outcomes to determine how successful these interventions have been and how these interventions could be improved in the future. The study will also seek to explore the perceptions and experiences of staff at the GP practices, commissioners and those who are managing the study to assess how the programme went and how things could be improved with the aim of improving patient services in the future.
Summary of Results
A mixed-methods study to evaluate the acceptability and potential clinical impact of a choice of dietary interventions delivered through digital group or 1 to 1 care to support weight loss and improve glycaemic control in adults with type 2 diabetes within an ethnically diverse population
IRAS ID: 295915
Name of the Research Ethics Committee that issued a Favourable Opinion for the study: North West - Greater Manchester East Research Ethics Committee
Sponsor Organisation Name: Oviva UK Ltd.
Study start date: 23/03/2022
Study end date: 19/09/2024
Funder's reference number: EIC191202
Name of Registry: ClinicalTrials.gov
Study Registration Number/Identifier: NCT05648903
Date of registration: 15/11/2022
Is the study protocol publicly available?: No
DOI/URL for most recent protocol:
Date original protocol was published:
Lay summary of study results: Introduction This study looked at three different dietary approaches for managing type 2 diabetes:
1.Total Diet Replacement (TDR): A very low-calorie diet where all meals were replaced with shakes and soups for a period of time.
2.Low Carbohydrate Diet (LC): Reducing daily carbohydrate intake to less than 130 grams per day.
3.Intermittent Fasting (5:2): Eating a balanced diet for five days and significantly reducing calories on two days each week.Key Findings
Diet Preferences and Engagement
-People from various backgrounds were willing to try different diets.
-TDR and LC were the most popular options, but the 5:2 approach was preferred by participants from Asian backgrounds.
-Remote, digital support was effective, with good participation and retention.
-Group support was useful initially but had higher dropout rates over time.
-One-to-one dietitian support led to better long-term engagement.
-Not everyone responds as expected, so close medical supervision is necessary.Weight Loss Results
-The most weight loss was seen in the TDR group, which is known to be highly effective for weight loss.
-The LC group had an average weight loss of under 5kg but showed similar improvements in blood sugar control as TDR.
-The highest individual weight losses recorded were:
-TDR: -25 kg (15% of body weight)
-LC: -14 kg (15% of body weight)
-5:2: -22 kg (19% of body weight)
-Ethnicity-based weight loss results after 12 months:
-Other: -10.6 kg (biggest average loss)
-Black-Caribbean: -9.4 kg
-Black-African: -7.38 kg
-Mixed: -5.7 kg
-White: -5.1 kg
-Participants who lost more weight tended to have better blood sugar improvements. Those who lost around 9 kg (7.8% of body weight) had the best HbA1c (blood sugar) improvements.
-Reducing carbohydrates alone, even without major weight loss, was beneficial for long-term blood sugar control.Blood Glucose Control (HbA1c Levels)
-Blood sugar control was measured using the HbA1c test, which reflects average blood sugar levels over several months.
-Diabetes remission was defined as having two HbA1c readings below 48 mmol/mol without diabetes medication for at least six months.
-After 6 months:
-Average HbA1c reduction: 9.4 mmol/mol.
-41% of participants achieved an HbA1c below 48 mmol/mol.
-After 12 months:
-Average HbA1c reduction: 3.5 mmol/mol.
-13 participants had HbA1c levels below 48 mmol/mol.
-The TDR group showed the biggest improvement, with an average HbA1c reduction of 5.6 mmol/mol.
-Nine participants achieved diabetes remission at both 6 and 12 months, with an average improvement of 13.0 mmol/mol. Five of these followed a Low Carbohydrate Diet.Blood Pressure & Cholesterol Improvements -Losing weight improved blood pressure readings.
-The TDR group had the biggest improvements in blood pressure, even though some participants reduced or stopped their blood pressure medications.
-All diet approaches helped lower triglyceride (fat) levels in the blood.
-The TDR group also had the best improvements in total cholesterol levels.Medication Reductions
-A total of 117 prescriptions were stopped, meaning each participant took 1.1 fewer medications on average.
-The TDR group saw the most medication reductions.
-Some medications, such as blood pressure drugs and diabetes medications (metformin and gliclazide), were restarted at lower doses in some cases.
-Only one prescription was restarted at the same dose.Conclusion
This study shows that different dietary approaches can help people manage type 2 diabetes, with varying results depending on the diet chosen. While TDR led to the most weight loss and medication reductions, LC also provided significant benefits, particularly for blood sugar control. The 5:2 approach was a preferred option for some groups. Digital support was effective, and personalized one-to-one dietitian guidance helped with long-term adherence. Close clinical monitoring remains essential, as not everyone responds in the same way.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
21/NW/0214
Date of REC Opinion
2 Sep 2021
REC opinion
Further Information Favourable Opinion