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

NCT03474393 | Completed DMC

• 1 other identifier: SIT-CGM/FGM
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c from baseline to week 18

  from baseline to 18 weeks

Secondary Outcomes (5)

• Time in Range

  from baseline to 18 weeks

• Mean glucose levels

  from baseline to 18 weeks

• Time above range

  from baseline to 18 weeks

• HbA1c at week 32

  From baseline to 18 weeks

• HbA1c at week 52

  From baseline to 52 weeks

Other Outcomes (9)

• Mean Glucose at week 32 and 52

  From baseline to 32 and 52 weeks

• Time below range week 18, 32 and 52

  From baseline to 18, 32 and 52 weeks

• Time above range weeks 32 and 52

  From baseline to weeks 32 and 52

Study Arms (2)

Normal diabetes care

NO INTERVENTION

Continue with their normal diabetes care. Come in for control visits

Systematic intensive therapy

EXPERIMENTAL

Intensive Internet and telephone contact for 4 months and Control visits

Other: systematic intensive therapy

Interventions

systematic intensive therapy OTHER

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

Systematic intensive therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

NU-Hosptial Group

Uddevalla, Sweden

Location

Related Publications (2)

• Olafsdottir AF, Sveen KA, Wijkman M, Hallstrom S, Nilsson PH, Sterner Isaksson S, Holmer H, Ekstrom M, Imberg H, Lind M. Systematic intensive therapy in addition to continuous glucose monitoring in adults with type 1 diabetes: a multicentre, open-label, randomised controlled trial. Lancet Reg Health Eur. 2025 Oct 16;59:101485. doi: 10.1016/j.lanepe.2025.101485. eCollection 2025 Dec.

  PMID: 41142656 DERIVED

• Olafsdottir AF, Lind M. Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial. Front Clin Diabetes Healthc. 2023 Oct 18;4:1247616. doi: 10.3389/fcdhc.2023.1247616. eCollection 2023.

  PMID: 37920192 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 22, 2018
• Study Start: November 1, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-02

Locations

SE (1)