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Completed

NCT Number: NCT03474393

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

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.

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Key information

Conditions

Type1diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NU-Hosptial Group

Uddevalla, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

systematic intensive therapy

Other

intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits

Primary outcomes

  1. Change in HbA1c

    Time frame: from baseline to 18 weeks

    Change in HbA1c from baseline to week 18

Secondary outcomes

  1. Time in Range

    Time frame: from baseline to 18 weeks

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

  2. Mean glucose levels

    Time frame: from baseline to 18 weeks

    Change in mean glucose levels from baseline to 18

  3. Time above range

    Time frame: from baseline to 18 weeks

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

  4. HbA1c at week 32

    Time frame: From baseline to 18 weeks

    Change in HbA1c from baseline to week 32

  5. HbA1c at week 52

    Time frame: From baseline to 52 weeks

    Change in HbA1c from baseline to week 52

Other outcomes

  1. Mean Glucose at week 32 and 52

    Time frame: From baseline to 32 and 52 weeks

    Change in mean glucose from baseline to week 32 and 52

  2. Time below range week 18, 32 and 52

    Time frame: From baseline to 18, 32 and 52 weeks

    Change in time below range (glucose values below 4.0mmol/l) from baseline to week 18, 32 and 52

  3. Time above range weeks 32 and 52

    Time frame: From baseline to weeks 32 and 52

    Change in time above range from baseline to 32 and 52 weeks

  4. Glycaemic variability - Standard deviation

    Time frame: From baseline to weeks 18, 32 and 52

    Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Standard deviation

  5. Glycaemic variability - Coefficient of variation

    Time frame: From baseline to weeks 18, 32 and 52

    Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Coefficient of variation

  6. Glycaemic variability - Mage

    Time frame: From baseline to weeks 18, 32 and 52

    Change in glycaemic variability from baseline to 18, 32 and 52 weeks using MAGE

  7. DTSQ

    Time frame: From baseline to weeks 18, 32 and 52

    Change in Diabetes Treatment and satisfaction (DTSQ) score from baseline to 18, 32 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions

  8. Hypoglycaemic confidence

    Time frame: From baseline to weeks 18, 32 and 52

    Change in Hypoglycaemic confidence score from baseline to 18 and 52 weeks. The hypoglycemic confidence scale is a 4pt Lickert scale with 9 questions

  9. Diabetes distress scale

    Time frame: From baseline to weeks 18, 32 and 52

    Change in Diabetes distress score (DDS) score from baseline to 18 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2018
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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