ON LiMiT Data Management Plan

Authors
Affiliation

Kristiane Beicher

Steno Diabetes Center Aarhus

Daniel Ibsen

Steno Diabetes Center Aarhus

Luke Johnston

Steno Diabetes Center Aarhus

Welcome!

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ON LiMiT (Optimal Non-pharmacological Lifestyle Modifications in people with Type 2 diabetes) is a large Danish intervention study investigating the maintenance of remission of type 2 diabetes through weight loss, diet, and exercise. The project runs from 2025 to 2030 and will involve 1,500 participants with type 2 diabetes.

Although the ON LiMiT study has been classified as not being a clinical drug trial by the Danish Medical Agency (DMA), we have chosen to align with best practices for clinical trials wherever possible. While a Data Management Plan (DMP) is not mandatory for a study such as ON LiMiT, it is strongly recommended for all research studies. This DMP ensures transparency, compliance, and integrity in handling participant data throughout the project lifecycle.

We follow a modified version of a DMP template from DeiC, mainly around how we describe access to data.

Collaborations

The project is being conducted in Aarhus, Odense, and Copenhagen and is a collaboration between Steno Diabetes Center Aarhus, Steno Diabetes Center Odense, Steno Diabetes Center Copenhagen, Bispebjerg Hospital, and the Department of Nutrition, Exercise and Sports and the Center for Basic Metabolic Research at the University of Copenhagen.

Governance and maintenance

This document will be maintained by members of the study team and has been approved for publication on the project website by the Project Manager on behalf of the Chief Investigator.

Funding

The project is funded by approximately DKK 102 million from the Novo Nordisk Foundation (Grant Number NNF24SA0097844).