Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 2403 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03682237
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Hillerod Hospital, Denmark
Hvidovre University Hospital
Bispebjerg Hospital
Rigshospitalet, Denmark
Frederiksberg University Hospital
Amager Hospital
Information provided by (Responsible Party):
Kirsten Nørgaard, Steno Diabetes Center Copenhagen

Brief Summary:

This study aims to compare the effect of flash glucose monitoring (FGM) with traditional self-monitoring of blood glucose (SMBG) with or without carbohydrate counting and automated bolus calculation, in patients with type 1 diabetes and poor metabolic control.

The investigators will include in total 200 patients recruited from 5 clinical sites in the Capital Region of Copenhagen.

The patients will be randomized into four groups; A) Standard diabetes training, i.e. group training in in general diabetes health issues, B) Group training in carbohydrate counting and automated bolus calculation, the app MySugr will be taught and downloaded, C) Group training as in group A, and instructed to use FGM, D) Group training as in group B, and besides training in the use of the app MySugr, also instructed to use FGM.

All patients are followed for 26 weeks with 6 clinical visits, group training (1 visit) and 2 telephone consultations.

The primary outcome is time spent in normoglycemia.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Carbohydrate counting, automated bolus calculation Device: Flash glucose monitoring (FGM) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Metabolic Control in Type 1 Diabetes With Multiple Daily Insulin Injections - Flash Glucose Monitoring, Carbohydrate Counting With Automated Bolus Calculation, or Both?
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

Arm Intervention/treatment
No Intervention: A) Standard diabetes training (control)

More specifically, group training in general diabetes health issues, how to do experienced based dosing, how to handle sick days, exercise etc. in general terms. The group will not be taught in carbohydrate counting or bolus calculation. They will be encouraged to measure SMBG at least 4 times daily with patients own preferred glucose meter.

Patients will be offered 6 months treatment with FGM after study end.

Active Comparator: B) Carbohydrate counting, automated bolus calculation Device: Carbohydrate counting, automated bolus calculation
Group training in carbohydrate counting and bolus calculation. The app MySugr will be taught and downloaded on own smart phone and person specific parameters will be estimated and entered in the app with the patients. SMBG measures at least 4 times daily with patients own preferred glucose meter.

Active Comparator: C) Flash glucose monitoring (FGM)
Group training with same content as for group A.
Device: Flash glucose monitoring (FGM)
Group training, patients will be instructed to use unblinded FGM for the whole study period. Patients are recommended to measure SMBG according to FGM manufactures guideline and handling of trend arrows etc.

Active Comparator: D) Carbohydrate counting, automated bolus calculation, FGM
Group training as group B. A more sophisticated education concept will be developed for how FGM should be used to adjust settings and suggestions from the automated bolus calculator (MySugr app).
Device: Carbohydrate counting, automated bolus calculation
Group training in carbohydrate counting and bolus calculation. The app MySugr will be taught and downloaded on own smart phone and person specific parameters will be estimated and entered in the app with the patients. SMBG measures at least 4 times daily with patients own preferred glucose meter.

Device: Flash glucose monitoring (FGM)
Group training, patients will be instructed to use unblinded FGM for the whole study period. Patients are recommended to measure SMBG according to FGM manufactures guideline and handling of trend arrows etc.




Primary Outcome Measures :
  1. Time in normoglycemia [ Time Frame: 26 weeks ]
    Difference in time in normoglycemic range 4-10 mmol/l at end of study measured by 2 weeks blinded FGM between group A (control group) and C (FGM) (min/day).


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 26 weeks ]
    Difference among groups in change in HbA1c (mmol/mol).

  2. Severe hypoglycemia [ Time Frame: 26 weeks ]
    Difference among groups in occurrence of severe hypoglycemia (defined as an event requiring assistance of another person. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal) (number of events during study period).

  3. Hypoglycemia [ Time Frame: 26 weeks ]
    Difference among groups in occurrence of symptomatic and confirmed hypoglycemia (< 3 mmol/l) (number of episodes per week).

  4. Diabetes distress [ Time Frame: 26 weeks ]
    Difference in changes in diabetes distress by the use of Problem Areas in Diabetes Questionnaire (PAID, score 0-100; higher scores reflecting diabetes distress).

  5. Diabetes treatment satisfaction [ Time Frame: 26 weeks ]
    Difference in changes in treatment satisfaction by the use of Diabetes Treatment Satisfaction Questionnaire (DTSQ, score 0-36; higher scores reflecting higher satisfaction).

  6. Diabetes empowerment [ Time Frame: 26 weeks ]
    Difference in changes in empowerment by the use of Diabetes empowerment test (DES-short form, containing 8 items, higher scores reflecting diabetes-related psychosocial self-efficacy. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point, and an overall score is calculated by adding all of the scores (8-40) and dividing by the number of completed items (highest number is 8)).

  7. Diabetes quality of life [ Time Frame: 26 weeks ]
    Difference in changes in life quality by the use of Diabetes quality of life (ADDQoL-19, scores -9-3, lower scores reflecting maximum negative impact).

  8. Blinded FGM hypoglycemia [ Time Frame: 26 weeks ]
    Difference in change in time spent in hypoglycemia (<3mmol/l, <4 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.

  9. Blinded FGM hyperglycemia [ Time Frame: 26 weeks ]
    Difference in change in time spent in hyperglycemia (>10 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.

  10. Blinded FGM glycemic variability [ Time Frame: 26 weeks ]
    Difference in change in glycemic variability (standard deviation) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.

  11. Personality traits [ Time Frame: 26 weeks ]
    Association between personality traits evaluated by the use of Neuroticism Extraversion Openness Agreeableness Conscientiousness Five-Factor Inventory-3 (NEO-Five Factors Inventory-3) questionnaire and any other outcome measures in the different groups. The NEO-Five Factors Inventory-3 covers five factors/domains that describe the commonly accepted personality traits. The inventory contains 60 statements that should be evaluated by self-ratings on a 5-point scale where 1 reflects "strongly disagree" and 5 reflects "strongly agree". The answers are related to the norm and based on these scores, personality traits are reported by the internet based Hogrefe Testsystem 5 (Hogrefe Publishing Group).

  12. Total insulin dose [ Time Frame: 26 weeks ]
    Difference in change between the groups in total insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.

  13. Total basal insulin dose [ Time Frame: 26 weeks ]
    Difference in change between the groups in total basal insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.

  14. Insulin boluses [ Time Frame: 26 weeks ]
    Difference in change between the groups in number of insulin boluses per day (number/day) recorded as a mean of 2 weeks during FGM blinded measurements.

  15. Body weight [ Time Frame: 26 weeks ]
    Difference among groups in body weight (kg).

  16. Urinary albumin/excretion rate [ Time Frame: 26 weeks ]
    Difference among groups in urinary albumin/excretion rate (mg/24 hours).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age >/= 18 years
  • HbA1c > 53 mmol/mol
  • Type 1 diabetes more than 1 year
  • Treated with basal and bolus insulin. Basal insulin can be taken once or twice daily. The percentage basal/bolus insulin should as judged by the investigator cover the patient's real need for basal insulin - if he or she is not eating and taking bolus
  • Patients may or may not have knowledge on carbohydrate counting
  • Patients may or may not have any experience with continuous glucose monitoring or FGM
  • Patients have a personal smart phone
  • Patients attend the outpatient clinic in one of the five study sites included in the study

Exclusion criteria:

  • Use of an automatic bolus calculator on a daily basis within the last three months
  • Daily use of continuous glucose monitoring or FGM on a daily basis within the last three months
  • Use of insulin pump
  • Use of Neutral Protamine Hagedorn insulin as long acting insulin (Insulatard, Humulin Retard) within the last three months
  • Pregnant, breastfeeding, plan to get pregnant
  • Gastroparesis
  • Severe diabetes complications including proliferative retinopathy and myocardial infarction within the last six months
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation as e.g. alcohol and drug abuse
  • Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
  • Inability to understand the individual information and to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682237


Contacts
Layout table for location contacts
Contact: Kirsten Nørgaard, MD, DMSc 0045 2713 1011 Kirsten.Noergaard@regionh.dk
Contact: Anna L Secher, MD, PhD 0045 2374 2764 anna.elisabet.lilja.secher@regionh.dk

Locations
Layout table for location information
Denmark
Steno Diabetes Center Copenhagen Recruiting
Copenhagen, Denmark
Contact: Anna L Secher, MD, PhD         
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Hillerod Hospital, Denmark
Hvidovre University Hospital
Bispebjerg Hospital
Rigshospitalet, Denmark
Frederiksberg University Hospital
Amager Hospital

Layout table for additonal information
Responsible Party: Kirsten Nørgaard, Principal Investigator, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03682237     History of Changes
Other Study ID Numbers: H-17040573
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kirsten Nørgaard, Steno Diabetes Center Copenhagen:
Hyperglycemia
Hypoglycemia
Carbohydrate counting
Automated bolus calculation
Flash glucose monitoring

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases