Type 2 DiabeteseDIT-pilotNCT04805996
The eHealth Diabetes Remission Trial - Pilot Study
A study testing Diabetes remission using total diet replacement and eHealth contact with the healthcare provider in people with Type 2 Diabetes, run by Julia Otten at 1 site in Sweden.
Trial summary
Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 23 Mar 2021to 29 Jan 2022
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with diabetes duration 0 to 6 years
- BMI 27-45 kg/m2
- Owning a smartphone
- HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication)
Who cannot join
- Insulin treatment
- Weight loss 5 kg or more during the past 6 months
- Treatment with weight loss medication
- Diagnosed eating disorder
- eGFR < 30 ml/min/1.73m2
- Substance abuse
Show all 10Show fewer
- Cancer
- Myocardial infarction during the past 6 months
- Severe heart failure
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Public Health and Clinical Medicine, Medicine
Umeå, 90187
About this study
Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended.
The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
- Keywords
- diabetes remission, weight loss, low-calorie diet, eHealth
- Medical subject headings
- Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes remission using total diet replacement and eHealth contact with the healthcare providerBehavioural
Participants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes remission using total diet replacement and eHealth contact with the healthcare provider | Experimental | This study has only one arm and no comparator. Receives: Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss goal of 15 kg, measured at the research facilities
Measured: 6 months
HbA1c
The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication. (Secondary goal < 42 mmol/mol.)
Measured: 6 months
Secondary outcomes (24)
Semi-structured interviews
Measured: 6 months
Fasting blood glucose
Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l)
Measured: Daily measurements up to 6 months
Fasting blood glucose
Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.
Measured: 6 months
P-glucose 120 minutes after the oral glucose tolerance test
Measured at the research facilities
Measured: 6 months
Insulin secretion
Measured with oral glucose tolerance test
Measured: At baseline, 3 months and 6 months
Insulin sensitivity
Measured with oral glucose tolerance test
Measured: At baseline, 3 months and 6 months
Metabolic flexibility
Measured with indirect calorimetry during oral glucose tolerance test
Measured: At baseline, 3 months and 6 months
Blood pressure (systolic/diastolic)
Measured at the research facilities
Measured: At baseline, 3 months and 6 months
Blood pressure (systolic/diastolic)
Measured at home
Measured: Daily measurements up to 6 months
Blood pressure medication
Change of blood pressure medication during the study
Measured: 6 months
Body weight
Measured at home
Measured: Daily measurements up to 6 months
HbA1c
Measured at home
Measured: Monthly measurement up to 6 months
Diabetes medication
Change of diabetes medication during study duration
Measured: 6 months
Plasma lipid profile
Measured at the research facilities
Measured: At baseline, 3 months and 6 months
Waist circumference
Measured in cm at the research facilities
Measured: Baseline, 3 months and 6 months
EQ-5D-5L
Questionnaire
Measured: At baseline, 3 months and 6 months
Food frequency form
Questionnaire
Measured: At baseline and 6 months
Daily steps
Measured with activity tracker
Measured: During the second three months of the study
HbA1c follow up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Body weight follow up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Blood pressure follow up (systolic/diastolic)
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Antidiabetic medication usage follow up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Blood pressure medication usage follow up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Diabetes complications follow up
Collected from patient journals and registries after study completion
Measured: Yearly up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start23 Mar 2021
- Primary completion29 Jan 2022
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julia Otten
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Sponsor-investigator, Julia Otten, Umeå University
- Investigators
- Julia Otten, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805996
- Sponsor's protocol ID
- Dnr 2021-00318
- Acronym
- eDIT-pilot
- Status last verified
- Jan 2022
- First submitted
- 13 Mar 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The eHealth Diabetes Remission Trial - Pilot Study
- ClinicalTrials.gov ID
- NCT04805996
- Acronym / sponsor ID
- eDIT-pilot / Dnr 2021-00318
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes remission, weight loss, low-calorie diet, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Julia OttenUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 18 Mar 2021 (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.
Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended.
The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes remission using total diet replacement and eHealth contact with the healthcare provider | Experimental | Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare providerThis study has only one arm and no comparator. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes with diabetes duration 0 to 6 years
- BMI 27-45 kg/m2
- Owning a smartphone
- HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication)
Key exclusion criteria (10 listed)
- Insulin treatment
- Weight loss 5 kg or more during the past 6 months
- Treatment with weight loss medication
- Diagnosed eating disorder
- eGFR < 30 ml/min/1.73m2
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 |
|---|---|---|
| Diabetes remission using total diet replacement and eHealth contact with the healthcare providerParticipants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team. | Behavioural | Diabetes remission using total diet replacement and eHealth contact with the healthcare provider |
Primary outcome
Weight loss
Time frame: 6 months
Weight loss goal of 15 kg, measured at the research facilities
HbA1c
Time frame: 6 months
The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication. (Secondary goal < 42 mmol/mol.)
24 secondary outcomes
Semi-structured interviews
Time frame: 6 months
Fasting blood glucose
Time frame: Daily measurements up to 6 months
Fasting blood glucose
Time frame: 6 months
P-glucose 120 minutes after the oral glucose tolerance test
Time frame: 6 months
Insulin secretion
Time frame: At baseline, 3 months and 6 months
Insulin sensitivity
Time frame: At baseline, 3 months and 6 months
Metabolic flexibility
Time frame: At baseline, 3 months and 6 months
Blood pressure (systolic/diastolic)
Time frame: At baseline, 3 months and 6 months
Blood pressure (systolic/diastolic)
Time frame: Daily measurements up to 6 months
Blood pressure medication
Time frame: 6 months
Body weight
Time frame: Daily measurements up to 6 months
HbA1c
Time frame: Monthly measurement up to 6 months
Diabetes medication
Time frame: 6 months
Plasma lipid profile
Time frame: At baseline, 3 months and 6 months
Waist circumference
Time frame: Baseline, 3 months and 6 months
EQ-5D-5L
Time frame: At baseline, 3 months and 6 months
Food frequency form
Time frame: At baseline and 6 months
Daily steps
Time frame: During the second three months of the study
HbA1c follow up
Time frame: Yearly up to 20 years
Body weight follow up
Time frame: Yearly up to 20 years
Blood pressure follow up (systolic/diastolic)
Time frame: Yearly up to 20 years
Antidiabetic medication usage follow up
Time frame: Yearly up to 20 years
Blood pressure medication usage follow up
Time frame: Yearly up to 20 years
Diabetes complications follow up
Time frame: Yearly up to 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
Julia Otten, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes remission using total diet replacement and eHealth contact with the healthcare provider in people with Type 2 Diabetes, run by Julia Otten at 1 site in Sweden.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 1 Feb 2022. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2022.