Diabetes Mellitus, Type 2
Conditions
Brief summary
This is a multicentre, open-label Randomised Controlled Trial run in the United Kingdom. The main aims are to assess whether the Habitual Remission Programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.
Detailed description
Participants will be randomly allocated to the Habitual Programme or standard care as delivered by the National Health Service (NHS). They will take a home blood test for HbA1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. These measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention. Participants will be recruited from General Practitioner (GP) surgeries in England, managed by Lindus Health. Research Nurses at Lindus Health will complete screening and informed consent procedures.
Interventions
COMBINATION_PRODUCTDigital therapeutic and intensive lifestyle programme
Initial 12-week LED and behaviour education app.
OTHERStandard of care
Standard of care.
Sponsors
Lindus Health
Habitual Health Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the lifestyle programme, participants, clinicians and data collectors will not be able to be masked, however allocation will be concealed from the statistician in charge of performing the analysis.
Intervention model description
A multicentre, open-label, parallel design, randomised controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to give consent for the study prior to participation * Be aged between 18-75 years, with type 2 Diabetes Mellitus of duration \<6years. * Has access to a smartphone or computer * Has a Body Mass Index (BMI) of ≥28 kg/m2 * HbA1C between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-months
Exclusion criteria
* Is currently using Insulin * Weight of change \>5% in the past 3-months * Has a history of are known to be suffering with alcohol/substance abuse * Has cancer or is knowingly under investigation for cancer * Has had a myocardial infarction within the previous 6-months * Has severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IV * Has porphyria * Has learning difficulties * Is currently on treatment with anti-obesity drugs * Has had bariatric surgery * Has been diagnosed with an eating disorder or purging * Is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years * Is currently breastfeeding * Has required hospitalisation for depression or taking antipsychotic drug * Has a history of illnesses that could interfere with the interpretation of the study (e.g. HIV, Cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, depression or antipsychotic drug use within the past 2 years) * Currently talking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) * Has pancreatitis * Currently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medication * Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss of ≥15kg | 6-months | Number of participants that achieved ≥15kg |
| HbA1C <6.5% (48mmol/mol) | 6-months | Number of participants who have achieved HbA1C \<6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure (SBP) | 3-months- 6-months | Changes in SBP from baseline to mid and endpoints. |
| Diastolic blood pressure (DBP) | 3-months- 6-months | Changes in DBP from baseline to mid and endpoints. |
| Medication use | Baseline, 3-months and 6-months | Medication use reported by the participant. |
| Glycaemic Control | 3-months- 6-months | Changes in HbA1C from baseline to mid and endpoints. |
| Safety of Intervention | Baseline- 6-months | Monitoring the number of Adverse Events (AEs), Severe Adverse Events (SAEs) and (S)AE's that constitute Major Adverse Cardiovascular Events and Major Adverse Diabetes Events |
| HbA1C <6.5% (48mmol/mol) | 12-months (6-months after completing the trial). | Number of participants with an HbA1C \<6.5% (48mmol/mol) after a 6-month follow up |
| Weight loss ≥10kg | 6-months | Number of participants that achieved ≥10kg |
| Weight control | 3-months- 6-months | Changes in weight from baseline to mid and endpoints. |
Countries
United Kingdom
Outcome results
None listed