NCT05678712

Brief Summary

The 16-week trial is an open-label cross-over trial which includes heamodialysis patients with T2D and T1D on insulin therapy. During one period, patients carry a non-blinded CGM. In the other period they follow standard procedures (the last two weeks with a blinded CGM). The patients and the dialysis staff can use the CGM measures to regulate insulin and food intake during the non-blinded weeks. The research group will collect the CGM-data during the trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 4, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

March 4, 2022

Last Update Submit

January 30, 2024

Conditions

HemodialysisType1diabetesType2Diabetes

Keywords

DiabetesHeamodialysisCGMGlycemic controlAlgorithm

Outcome Measures

Primary Outcomes (1)

  • time below range (CGM)

    Change in time below range (CGM) (\< 3.0 mmol/L)

    6 weeks of treatment in each of the two treatment periods

Secondary Outcomes (7)

  • Time in range (CGM)

    6 weeks of treatment in each of the two treatment periods

  • Time in borderline low range (CGM)

    6 weeks of treatment in each of the two treatment periods

  • Time above range (CGM)

    6 weeks of treatment in each of the two treatment periods

  • Time above range (CGM) (high)

    6 weeks of treatment in each of the two treatment periods

  • Concentration of HbA1c

    6 weeks of treatment in each of the two treatment periods

  • +2 more secondary outcomes

Other Outcomes (3)

  • Hypo- and hyperglycemic episodes

    6 weeks of treatment in each of the two treatment periods

  • Insulin requirements

    6 weeks of treatment in each of the two treatment periods

  • Diabetes-related quality of life

    Week 0, week 6, week 8, week 14

Study Arms (2)

Standard treatment

NO INTERVENTION

After a two weeks "run-in" baseline period (blinded CGM) some of the participants (1:1) were randomly assigned to six weeks of standard treatment, i.e. self monitoring of blood glucose (the last two weeks with blinded CGM → 2 weeks "wash-out" (baseline for next period) (blinded CGM) → six weeks with non-blinded CGM with data available for the patient himself/herself and dialysis staff

Intervention (access to CGM data)

EXPERIMENTAL

After a two weeks "run-in" baseline period (blinded CGM) some of the participants (1:1) were randomly assigned to six weeks with non-blinded CGM with data available for the patient himself/herself and dialysis staff → 2 weeks "wash-out" (baseline for next period) (blinded CGM) → Six weeks of standard treatment, i.e. self monitoring of blood glucose (the last two weeks with blinded CGM

Device: Access to CGM data (Dexcom G6)

Interventions

Access to CGM data (Dexcom G6)DEVICE

Acces to CGM data (not blinded CGM)

Intervention (access to CGM data)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years
  • Chronically ill heamodialysis patients (heamodialysis or heamodiafiltration - treatment)der modtager HD- eller hæmodiafiltrationsbehandling på dialyseafsnit,--
  • Patients at dialysis wards in Aalborg and Hjørring, Aalborg University Hospital (center and home patients)
  • T1D or T2D and in treatment with insulin
  • Being able to use CGM equipment
  • Signed consent

You may not qualify if:

  • Pregnancy or breastfeeding,
  • Terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate
  • Patients undergoing peritoneal dialysis (PD) or heamofiltration dialysis (HF)
  • Acute HD treatment
  • Gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of nephrology (dialysis)

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sisse Heiden Laursen, PhD

    Aalborg University

    PRINCIPAL INVESTIGATOR

  • Peter Vestergaard, PhD (and MD)

    Aalborg University Hospital and Steno Diabetes Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor

Study Record Dates

First Submitted

March 4, 2022

First Posted

January 10, 2023

Study Start

March 9, 2022

Primary Completion

December 18, 2023

Study Completion

December 18, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

DK(1)