NCT04819178

Brief Summary

The primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (DKA) during treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

March 15, 2021

Last Update Submit

February 10, 2022

Conditions

Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

  • Diabetic ketoacidosis

    Registration of incidents of DKA will be done based on data from medical records, as well as reporting from patients and registries.

    3 years

Secondary Outcomes (4)

  • Efficacy of treatment

    3 years

  • Patient reported outcome

    3 years

  • Side effects

    3 years

  • Hypoglyceamia

    3 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with type 1 diabetes initiated on SGLT2 inhibition will be prospectively included after provision of informed consent. We have established a national network of centers and investigators involved in the treatment of type 1 diabetes. We aim to offer inclusion in the study to every individual where SGLT2 inhibitor treatment is planned

You may qualify if:

  • All patiens with type 1 diabetes on SGLT2 inhibitor treatment or where this treatment is planned.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

Location

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Steno Diabetes Center Region Sjaelland

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

KetosisAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Frederik Persson, MD, DMsc

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DM, Peter Rossing

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 26, 2021

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

DK(3)