Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections

Long-term Effects of Continuous Glucose Monitoring in Patients With Type 1 Diabetes Treated With Multiple Daily Insulin Injections - Extension of CGMMDI Trial

A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels have been an essential part of insulin dosing before meals. However, in recent years continuous glucose monitoring (CGM) has become a treatment option to inform the patient when glucose levels may be too high or low.

In some countries, including Sweden, CGM is reimbursed only when combined with continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a history of repeated severe hypoglycaemia in adults with type 1 diabetes. This is based on existing clinical trial data showing a beneficial effect on HbA1c when CGM is combined with CSII. However, despite the fact that the majority of adults with type 1 diabetes are treated with multiple daily insulin injections (MDI), studies on the effect of CGM in patients with type 1 diabetes treated with MDI are sparse. Therefore, the investigators initiated the CGMMDI trial, an ongoing, cross-over clinical trial including 161 MDI patients receiving CGM over 6 months, followed by conventional therapy over six months, with a four-month wash-out period in-between treatment. Evaluations include glycaemic control, hypoglycaemia, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.

From a research or regulatory standpoint, long-term data on treatment effects are expected to a greater extent today than in previous years, due to various reasons, e.g., to evaluate any sustained beneficial effects over time, or long-term patient safety. Accordingly, follow-up of treatment in an extension phase after randomized diabetes trials have become more common over time, especially where many novel glucose-lowering treatments are concerned. Therefore, the aim of the current study is to evaluate long-term effects of CGM in patients with type 1 diabetes treated with MDI. Patients who consent in an extension phase over 1 year of the CGMMDI trial will receive CGM, and evaluations will be performed on sustained glycaemic control effects, hypoglycaemia, glycaemic variability, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 1
• Intervention / Treatment: Device: Dexcom G4 or later generation

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Alingsås, Sweden
    • Alingsås Hospital
  • Angered, Sweden
    • Angered Hospital
  • Helsingborg, Sweden
    • Helsingborg Hospital
  • Härnösand, Sweden
    • Öbackakliniken
  • Kristianstad, Sweden
    • Central Hospital Kristianstad
  • Kungsbacka, Sweden
    • Halland Hospital Kungsbacka
  • Malmö, Sweden
    • Skåne University Hospital Malmö
  • Motala, Sweden
    • Hospital in Motala
  • Norrköping, Sweden
    • Vrinnevi Hospital
  • Stockholm, Sweden
    • Sodersjukhuset
  • Trelleborg, Sweden
    • Hospital Trelleborg
  • Uddevalla, Sweden
    • NU Hospital Group
  • Uppsala, Sweden
    • Academic Hospital Uppsala
  • Ängelholm, Sweden
    • Ängelholm Hospital
  • Örebro, Sweden
    • University hospital Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Completion of the CGMMDI trial.
• Written informed consent.

Exclusion Criteria:

• Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months
• Severe cognitive dysfunction or other disease, which is adjudicated by a physician as not suitable for inclusion.
• Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the Dexcom. However, other pain killers can be used throughout the study duration.
• History of allergic reaction to any of the CGM materials or adhesives in contact with the skin, or to chlorhexidine or alcoholic anti-septic solution.
• Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
• Other investigator-determined criteria making patients unsuitable for participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long-term CGM; Continuous glucose monitoring with DexCom G4 platina or later generations during 12 months following participation in the CGMMDI trial	Device: Dexcom G4 or later generation; Continuous glucose monitoring with DexCom G4 platina or later generations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c in venous sample	For all variables, measurement at the end of this extension of a cross-over study will be compared to the measurement before long-term CGM was initiated.	52 weeks or 78 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose level measured by CGM during two weeks.		52 weeks/78 weeks
Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.		52 weeks/78 weeks
Standard deviation of glucose levels measured by CGM during two weeks.		52 weeks/78 weeks
Treatment satisfaction: DTSQs scores	Diabetes Treatment Satisfaction Questionnaire (Status)	52 weeks/78 weeks
Well being: WHO 5 scores	Questionnaire	52 weeks/78 weeks
Hypoglycemia fear: SWE-HFS scores	Swedish Hypoglycaemia Fear Scale Questionnaire	52 weeks/78 weeks
Problem areas: SWE-PAID-20 scores	Swedish Problem Areas In Diabetes Questionnaire	52 weeks/78 weeks
Physical activity: IPAQ score	International Physical Activity Questionnaire	52 weeks/78 weeks
Treatment experience of CGM score	Questionnaire developed for this trial	52 weeks/78 weeks
Proportion of time with low glucose levels measured by CGM during two weeks.	Below 3.0 mmol/l and below 4.0 mmol/l, respectively.	52 weeks/78 weeks
Proportion of time with high glucose levels measured by CGM during two weeks.	Above 10.0 mmol/l and above 13.9 mmol/l, respectively.	52 weeks/78 weeks
Proportion of time with euglycaemic levels measured by CGM during two weeks.	5.5-10.0 mmol/l and 3.9-10.0 mmol/l, respectively.	52 weeks/78 weeks
Proportion of patients lowering their HbA1c by 5 mmol/mol (0.5% in DCCT) or more.		52 weeks/78 weeks
Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more		52 weeks/78 weeks
Number of self-reported severe hypoglycaemic events per year	Defined as unconsciousness due to hypoglycaemia or need for assistance from another person to resolve hypoglycaemia.	52 weeks/78 weeks

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Marcus Lind, MD, PhD, NU Hospital Group and University of Gothenburg

Publications and helpful links

General Publications

• Lind M, Olafsdottir AF, Hirsch IB, Bolinder J, Dahlqvist S, Pivodic A, Hellman J, Wijkman M, Schwarcz E, Albrektsson H, Heise T, Polonsky W. Sustained Intensive Treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI. Diabetes Care. 2021 Jan;44(1):141-149. doi: 10.2337/dc20-1468. Epub 2020 Nov 15.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CGMMDI Extension