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A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care

Not Applicable
Completed
Conditions
Type1diabetes
Interventions
Other: systematic intensive therapy
Registration Number
NCT03474393
Lead Sponsor
Vastra Gotaland Region
Brief Summary

This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed.

A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM.

The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.

The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
117
Inclusion Criteria
  • Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
  • Clinical diagnosis of Type 1 diabetes
  • Adult patients over 18 years of age
  • HbA1c ≥ 58 mmol/mol
  • Currently using CGM or FGM
  • To have a possibility to download and share FGM/CGM data
Exclusion Criteria
  • Type 2 diabetes
  • Diabetes duration <1 year
  • Long-term Systemic glucocorticoid treatment during the last 3 months
  • Planned or changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
  • Current or planned pregnancy or breastfeeding during the next 12 months
  • Planned move during the next 12 months making it not possible to participate in study activities
  • Other reason determined by the investigator not being appropriate for participation

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Systematic intensive therapysystematic intensive therapyIntensive Internet and telephone contact for 4 months and Control visits
Primary Outcome Measures
NameTimeMethod
Change in HbA1cfrom baseline to 18 weeks

Change in HbA1c from baseline to week 18

Secondary Outcome Measures
NameTimeMethod
Time in Rangefrom baseline to 18 weeks

Change in Time in Range (4-10mmol/l) and from Baseline to week 18

Mean glucose levelsfrom baseline to 18 weeks

Change in mean glucose levels from baseline to 18

HbA1c at week 52From baseline to 52 weeks

Change in HbA1c from baseline to week 52

HbA1c at week 32From baseline to 18 weeks

Change in HbA1c from baseline to week 32

Time above rangefrom baseline to 18 weeks

Change in time above range (glucose values above 10mmol/L) from baseline to 18 weeks

Trial Locations

Locations (1)

NU-Hosptial Group

🇸🇪

Uddevalla, Sweden

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