Type 1 DiabetesMIDDAS T1NCT04674384
Manchester Intermittent and Daily Diet Type 1 Diabetes App Study (MIDDAS-Type 1)
A study testing Optifast meal replacement shakes in people with Type 1 Diabetes and Obesity, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To assess the safety, acceptability and feasibility of testing Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) programmes for 12 weeks in a real life setting with people with T1D and obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Obesity
- What is being tested?
- Optifast meal replacement shakes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1D for 12 months or longer
- HbA1c 53-108 mmol/mol
- BMI ≥ 30 kg/m2 and <50kg/ m2 or ≥27.5 kg/ m2 and <50kg/ m2 in high-risk minority ethnic groups i.e. South Asian, Black African and African Caribbean
- Multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
- Completed Dose Adjustment For Normal Eating (DAFNE) education
- Access to a Freestyle Libre handset and sensors to monitor blood glucose
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- Willing to use the Freestyle Libre® flash glucose monitoring system to monitor blood glucose (flash and capillary) and blood ketones and to record carbohydrate and insulin.
- Access to and ability to use a telephone. If no access to a smartphone running iOS or Android (to view the LibreLink app®) then access to a computer (to upload results to the LibreView website).
- Willing to undertake Optifast® LEDs and have previously sampled Optifast®.
- Negative urine pregnancy test at screening and agreement to maintain contraception or abstinence for the trial (where appropriate)
- Ability to read, understand and communicate in English.
Who cannot join
- Evidence of severe hypoglycaemia in the last 12 months (more than one episode requiring third party assistance) or hypoglycaemia unawareness.
- Patients with non-stable retinopathy, or grade R2 or later, or had no retinopathy screen within 12 months.
- Patients who lack capacity or are unable to read or understand written or verbal instructions in English or those diagnosed with learning difficulties.
- Confirmed pregnant via a pregnancy test at screening, planning pregnancy in the next 3 months, or currently breast feeding.
- Participants who are currently on treatment with Orlistat or other pharmacological treatments for weight loss e.g. Glucagon-like-peptide-1 (GLP-1).
- Participants who are currently taking a Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor.
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- Diagnosed Gastroparesis.
- Participants who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy.
- Patients who are on chronic use of steroids (more than 20mg daily of prednisolone or its equivalent).
- Patients with known hypersensitivity to any of the ingredients of Optifast® e.g. fish, milk, soy.
- Taking prohibited medications (see Appendix 3) including warfarin or novel anticoagulants (NOAC), low molecular weight heparin (LMWH) or equivalent anti-coagulants and anti-psychotic medication or other psychotropic medications that may cause excessive weight gain.
- Substance abuse or harmful alcohol use as indicated by a score of 16 or above on the Alcohol Use Disorders Identification Test (AUDIT).[36]
- Participants with a diagnosed eating disorder, or patients with severe binge eating assessed by a score of 27 or more on the Binge Eating Scale (BES).[37]
- Participants with severe depression assessed by a score of 15 or more on the Patient Health Questionnaire-9 (PHQ-9) questionnaire.[29]
- Participants with severe anxiety assessed by a score of 15 or more on the General Anxiety Disorder (GAD-7) questionnaire.[28]
- Participants with very low self-efficacy assessed by a score of 35 or less on the Weight Efficacy Lifestyle Questionnaire (WEL-SF).[30]
- Participants with severe loss of renal function (eGFR < 30mL/min/1.73m2).
- Participants with psychiatric or physical comorbidity or scheduled for major surgery, which in the opinion of the treating medical physician, Chief Investigator (CI) or Multidisciplinary Team (MDT) would compromise their safety or adherence to the study.
- Unsatisfactory use of the Freestyle Libre® flash glucose monitoring system or unsafe use of DAFNE/insulin adjustment principles during the 14-day "run-in" period that in the opinion of the medical team may undermine the participant's safety on the trial. This includes flash and capillary monitoring of blood glucose and ketone testing.
- Patients who are currently participating in a diabetes drug trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9QZ
James Yates, 0161 291 4410, James.Yates@mft.nhs.uk
Basil Issa
About this study
Official title: A Randomised Feasibility Trial of an Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) in Patients With Type 1 Diabetes and Obesity
To assess the safety, acceptability and feasibility of testing Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) programmes for 12 weeks in a real life setting with people with T1D and obesity.
Read the detailed description
The study described herein is a small randomised, open-label, single centre feasibility study of 12 patients with T1D and obesity. The aim of the study is to assess the safety, acceptability and feasibility of ILED (850kcal/day 2 days/week) and CLED (850kcal/day) over 12 weeks in a real life setting with people with T1D and obesity to help them lose weight and improve their glycaemic control. The low energy diets will involve Nestle Optifast® meal replacements as a total diet replacement (TDR).
People with T1D are becoming increasingly accustomed to remote monitoring of their blood glucose by health professionals using several continuous glucose monitoring devices including the Freestyle Libre® flash glucose monitoring system. The Freestyle Libre® allows healthcare professionals to view patient blood glucose trends and patterns from the web-based platform Libreview®. The study described herein will also assess the safety and practicality of providing remote follow-up support by healthcare professionals (dietitian, nurse and psychologist) to patients with T1D and obesity during the course of implementing the low energy diets. High-frequency remote follow up has been shown to be superior to low-frequency face-to-face care in weight management interventions. Remote care reduces participants' burden to attend face-to-face appointments and may be cost-effective compared with face-to-face care whilst improving access to care. The study described herein will incorporate high-frequency remote follow up via telephone and/or the Oviva® smartphone application facilitating messaging, video calls and self-monitoring of weight and blood pressure. The Freestyle Libre® flash glucose monitoring system will facilitate remote review of blood glucose readings.
Positive results from this feasibility study of two different low energy diets will inform whether one or both diets go forward into a large and longer term randomised efficacy trial following the Medical Research Council complex intervention guidance. This could provide the evidence base to inform the use of low energy diets in individuals with T1D and obesity for weight loss to improve their metabolic status and reduce the risk of cardiovascular and other physical and mental co morbidities associated with T1D.
- Conditions
- Type 1 Diabetes, Obesity
- Being tested
- Optifast meal replacement shakes
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optifast meal replacement shakesDietary supplement
Optifast® is provided as 53g sachet. Each sachet replaces one meal. It is available in 5 flavours: vanilla, strawberry, chocolate and coffee shakes and vegetable soup.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Low Energy Diet (ILED) | Active comparator | Not described Receives: Dietary Supplement: Optifast meal replacement shakes |
| Continuous Low Energy Diet (CLED) | Active comparator | Not described Receives: Dietary Supplement: Optifast meal replacement shakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of severe hypoglycaemia i.e. capillary blood glucose < 3.0 mmol/l or requiring 3rd party assistance or any episodes of nocturnal hypoglycaemia <3.0 mmol/l.
Measured: 14 week duration of study
Time spent in target (3.9-10mmol/l), below target (<3.9mmol/l and <3.0mmol/l) and above target (>10 mmol/l) on the Freestyle Libre® flash glucose monitoring system over 12 weeks.
Measured: 14 week duration of study
Number of episodes of Diabetic Ketoacidosis (DKA) and blood ketone β-hydroxybutyrate levels above 1.0mmol/l.
Measured: 14 week duration of study
Occurrence of Serious Adverse Events (SAEs) deemed potentially related to the dietary programmes.
Measured: 14 week duration of study
Secondary outcomes (12)
Uptake to the trial i.e. percentage of those invited who are eligible and interested to take part
Measured: 14 week duration of study
Number of participants who complete the trial measured by attendance at the 12 week appointment (for ILED and CLED)
Measured: 14 week duration of study
Adherence to blood glucose and ketone monitoring i.e. frequency of capillary blood tests and scans
Measured: 14 week duration of study
Percentage of low energy days completed (for ILED and CLED)
Measured: 14 week duration of study
Dietary intake (7 day food diary). Food diaries will be analysed using Nutritics nutrition analysis software to estimate energy, fat, saturated fat, carbohydrate and protein intake
Measured: 14 week duration of study
Anonymous patient evaluation of the dietary programmes using an end of study questionnaire
The End of Study Questionnaire will be analysed using appropriate descriptive statistics for closed questions (scales 1 to 10 with 1 indicating "not at all" and 10 indicating "extremely" in the context of questions around satisfaction, ease of completion etc.). Key themes will be extracted without formal analysis from open questions to inform future research.
Measured: 14 week duration of study
Percentage of multi-disciplinary team contacts with participants achieved (for ILED and CLED)
Measured: 14 week duration of study
Uptake to and continued use of the Oviva® app i.e. percentage of participants willing to try the app and those who continue to use the different app functions over the 12 week period.
Measured: 14 week duration of study
Number of other adverse effects potentially associated with the dietary programmes e.g. constipation, fatigue
Measured: 14 week duration of study
Number of participants preferring food-based low energy days (for ILED and CLED)
Measured: 14 week duration of study
Average time spent by the MDT (for ILED and CLED)
Measured: 14 week duration of study
Percentage of contacts with Dietitian conducted face to face after baseline (for ILED and CLED)
Measured: 14 week duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start19 Jan 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674384
- Sponsor's protocol ID
- B01030
- Acronym
- MIDDAS T1
- Status last verified
- May 2023
- First submitted
- 9 Dec 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDiarmid S, Harvie M, Aglan A, Winterbottom H, Mubita W, Hulme A, Davies J, Yates J, Krizak S, Perry D, Issa BG. Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1): protocol for a randomised feasibility trial of an intermittent and continuous low-energy diet in patients with type 1 diabetes and overweight and obesity. BMJ Open. 2023 Jul 20;13(7):e071395. doi: 10.1136/bmjopen-2022-071395.
PubMed 37474169
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Trial of an Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) in Patients With Type 1 Diabetes and Obesity
- ClinicalTrials.gov ID
- NCT04674384
- Acronym / sponsor ID
- MIDDAS T1 / B01030
- Conditions
- Type 1 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety, acceptability and feasibility of testing Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) programmes for 12 weeks in a real life setting with people with T1D and obesity.
Detailed description
The study described herein is a small randomised, open-label, single centre feasibility study of 12 patients with T1D and obesity. The aim of the study is to assess the safety, acceptability and feasibility of ILED (850kcal/day 2 days/week) and CLED (850kcal/day) over 12 weeks in a real life setting with people with T1D and obesity to help them lose weight and improve their glycaemic control. The low energy diets will involve Nestle Optifast® meal replacements as a total diet replacement (TDR).
People with T1D are becoming increasingly accustomed to remote monitoring of their blood glucose by health professionals using several continuous glucose monitoring devices including the Freestyle Libre® flash glucose monitoring system. The Freestyle Libre® allows healthcare professionals to view patient blood glucose trends and patterns from the web-based platform Libreview®. The study described herein will also assess the safety and practicality of providing remote follow-up support by healthcare professionals (dietitian, nurse and psychologist) to patients with T1D and obesity during the course of implementing the low energy diets. High-frequency remote follow up has been shown to be superior to low-frequency face-to-face care in weight management interventions. Remote care reduces participants' burden to attend face-to-face appointments and may be cost-effective compared with face-to-face care whilst improving access to care. The study described herein will incorporate high-frequency remote follow up via telephone and/or the Oviva® smartphone application facilitating messaging, video calls and self-monitoring of weight and blood pressure. The Freestyle Libre® flash glucose monitoring system will facilitate remote review of blood glucose readings.
Positive results from this feasibility study of two different low energy diets will inform whether one or both diets go forward into a large and longer term randomised efficacy trial following the Medical Research Council complex intervention guidance. This could provide the evidence base to inform the use of low energy diets in individuals with T1D and obesity for weight loss to improve their metabolic status and reduce the risk of cardiovascular and other physical and mental co morbidities associated with T1D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Low Energy Diet (ILED) | Active comparator | Dietary Supplement: Optifast meal replacement shakes |
| Continuous Low Energy Diet (CLED) | Active comparator | Dietary Supplement: Optifast meal replacement shakes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- T1D for 12 months or longer
- HbA1c 53-108 mmol/mol
- BMI ≥ 30 kg/m2 and <50kg/ m2 or ≥27.5 kg/ m2 and <50kg/ m2 in high-risk minority ethnic groups i.e. South Asian, Black African and African Caribbean
- Multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
- Completed Dose Adjustment For Normal Eating (DAFNE) education
Key exclusion criteria (20 listed)
- Evidence of severe hypoglycaemia in the last 12 months (more than one episode requiring third party assistance) or hypoglycaemia unawareness.
- Patients with non-stable retinopathy, or grade R2 or later, or had no retinopathy screen within 12 months.
- Patients who lack capacity or are unable to read or understand written or verbal instructions in English or those diagnosed with learning difficulties.
- Confirmed pregnant via a pregnancy test at screening, planning pregnancy in the next 3 months, or currently breast feeding.
- Participants who are currently on treatment with Orlistat or other pharmacological treatments for weight loss e.g. Glucagon-like-peptide-1 (GLP-1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optifast meal replacement shakesOptifast® is provided as 53g sachet. Each sachet replaces one meal. It is available in 5 flavours: vanilla, strawberry, chocolate and coffee shakes and vegetable soup. | Dietary supplement | Continuous Low Energy Diet (CLED), Intermittent Low Energy Diet (ILED) |
Primary outcome
Number of episodes of severe hypoglycaemia i.e. capillary blood glucose < 3.0 mmol/l or requiring 3rd party assistance or any episodes of nocturnal hypoglycaemia <3.0 mmol/l.
Time frame: 14 week duration of study
Time spent in target (3.9-10mmol/l), below target (<3.9mmol/l and <3.0mmol/l) and above target (>10 mmol/l) on the Freestyle Libre® flash glucose monitoring system over 12 weeks.
Time frame: 14 week duration of study
Number of episodes of Diabetic Ketoacidosis (DKA) and blood ketone β-hydroxybutyrate levels above 1.0mmol/l.
Time frame: 14 week duration of study
Occurrence of Serious Adverse Events (SAEs) deemed potentially related to the dietary programmes.
Time frame: 14 week duration of study
12 secondary outcomes
Uptake to the trial i.e. percentage of those invited who are eligible and interested to take part
Time frame: 14 week duration of study
Number of participants who complete the trial measured by attendance at the 12 week appointment (for ILED and CLED)
Time frame: 14 week duration of study
Adherence to blood glucose and ketone monitoring i.e. frequency of capillary blood tests and scans
Time frame: 14 week duration of study
Percentage of low energy days completed (for ILED and CLED)
Time frame: 14 week duration of study
Dietary intake (7 day food diary). Food diaries will be analysed using Nutritics nutrition analysis software to estimate energy, fat, saturated fat, carbohydrate and protein intake
Time frame: 14 week duration of study
Anonymous patient evaluation of the dietary programmes using an end of study questionnaire
Time frame: 14 week duration of study
Percentage of multi-disciplinary team contacts with participants achieved (for ILED and CLED)
Time frame: 14 week duration of study
Uptake to and continued use of the Oviva® app i.e. percentage of participants willing to try the app and those who continue to use the different app functions over the 12 week period.
Time frame: 14 week duration of study
Number of other adverse effects potentially associated with the dietary programmes e.g. constipation, fatigue
Time frame: 14 week duration of study
Number of participants preferring food-based low energy days (for ILED and CLED)
Time frame: 14 week duration of study
Average time spent by the MDT (for ILED and CLED)
Time frame: 14 week duration of study
Percentage of contacts with Dietitian conducted face to face after baseline (for ILED and CLED)
Time frame: 14 week duration of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 37474169McDiarmid S, Harvie M, Aglan A, Winterbottom H, Mubita W, Hulme A, Davies J, Yates J, Krizak S, Perry D, Issa BG. Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1): protocol for a randomised feasibility trial of an intermittent and continuous low-energy diet in patients with type 1 diabetes and overweight and obesity. BMJ Open. 2023 Jul 20;13(7):e071395. doi: 10.1136/bmjopen-2022-071395.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manchester University NHS Foundation Trust
Manchester, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optifast meal replacement shakes in people with Type 1 Diabetes and Obesity, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes of severe hypoglycaemia i.e. capillary blood glucose < 3.0 mmol/l or requiring 3rd party assistance or any episodes of nocturnal hypoglycaemia <3.0 mmol/l. (time frame: 14 week duration of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.