---
title: The eHealth Diabetes Remission Trial - Pilot Study
nct_id: NCT04805996
overall_status: COMPLETED
phase: NA
sponsor: Julia Otten
study_type: INTERVENTIONAL
primary_condition: Type 2 Diabetes
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04805996.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04805996"
ct_last_update_post_date: 2022-02-01
last_seen_at: "2026-05-12T06:14:07.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The eHealth Diabetes Remission Trial - Pilot Study

**NCT ID:** [NCT04805996](https://clinicaltrials.gov/study/NCT04805996)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Julia Otten
- **Collaborators:** Region Västerbotten
- **Conditions:** Type 2 Diabetes
- **Start Date:** 2021-03-23
- **Completion Date:** 2022-01-29
- **CT.gov Last Update:** 2022-02-01

## Brief 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). 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Cancer
* Myocardial infarction during the past 6 months
* Severe heart failure
* Pregnancy
```

## Arms

- **Diabetes remission using total diet replacement and eHealth contact with the healthcare provider** (EXPERIMENTAL) — This study has only one arm and no comparator.

## Interventions

- **Diabetes remission using total diet replacement and eHealth contact with the healthcare provider** (BEHAVIORAL) — 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.

## Primary Outcomes

- **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.)

## 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)_

## Locations (1)

- Department of Public Health and Clinical Medicine, Medicine, Umeå, Sweden

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of public health and clinical medicine, medicine|umeå||sweden` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04805996*  
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