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

A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes
• Intervention / Treatment: Other: systematic intensive therapy

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uddevalla, Sweden
    • NU-Hosptial Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal diabetes care; Continue with their normal diabetes care. Come in for control visits
Experimental: Systematic intensive therapy; Intensive Internet and telephone contact for 4 months and Control visits	Other: systematic intensive therapy; intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Change in HbA1c from baseline to week 18	from baseline to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Range	Change in Time in Range (4-10mmol/l) and from Baseline to week 18	from baseline to 18 weeks
Mean glucose levels	Change in mean glucose levels from baseline to 18	from baseline to 18 weeks
Time above range	Change in time above range (glucose values above 10mmol/L) from baseline to 18 weeks	from baseline to 18 weeks
HbA1c at week 32	Change in HbA1c from baseline to week 32	From baseline to 18 weeks
HbA1c at week 52	Change in HbA1c from baseline to week 52	From baseline to 52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Glucose at week 32 and 52	Change in mean glucose from baseline to week 32 and 52	From baseline to 32 and 52 weeks
Time below range week 18, 32 and 52	Change in time below range (glucose values below 4.0mmol/l) from baseline to week 18, 32 and 52	From baseline to 18, 32 and 52 weeks
Time above range weeks 32 and 52	Change in time above range from baseline to 32 and 52 weeks	From baseline to weeks 32 and 52
Glycaemic variability - Standard deviation	Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Standard deviation	From baseline to weeks 18, 32 and 52
Glycaemic variability - Coefficient of variation	Change in glycaemic variability from baseline to 18, 32 and 52 weeks using Coefficient of variation	From baseline to weeks 18, 32 and 52
Glycaemic variability - Mage	Change in glycaemic variability from baseline to 18, 32 and 52 weeks using MAGE	From baseline to weeks 18, 32 and 52
DTSQ	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	From baseline to weeks 18, 32 and 52
Hypoglycaemic confidence	Change in Hypoglycaemic confidence score from baseline to 18 and 52 weeks. The hypoglycemic confidence scale is a 4pt Lickert scale with 9 questions	From baseline to weeks 18, 32 and 52
Diabetes distress scale	Change in Diabetes distress score (DDS) score from baseline to 18 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions	From baseline to weeks 18, 32 and 52

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: SIT-CGM/FGM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No