An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) (IMPACT)

Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes

The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Sensor Based Glucose Monitoring System; Device: Standard Blood Glucose Monitoring

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria, 6807
    • VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
  • Graz, Austria, 8036
    • Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Salzburg, Austria, 5020
    • Diakonissen-Krankenhaus Salzburg
  • Wien, Austria, 1090
    • Klinik fuer Innere Medizin III Medizinische Universitaet Wien
  • Wien, Austria, 1160
    • Wilhelminenspital Medzin 5
• Germany
  • Bad Mergentheim, Germany, 97980
    • Diabetes Klinik Bad Mergentheim
  • Hamburg, Germany, 21029
    • Zentrum für Diabetologie Hamburg Bergedorf
  • Hannover, Germany, 30165
    • Diabetes-Zentrum Hannover-Nord
  • Quakenbrück, Germany, 49610
    • Diabetes Center Quakenbruck
  • Sūlzbach-Rosenberg, Germany, 92237
    • Versdias GmbH
• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • Vrije Universiteit Medisch Centrum
  • Amsterdam, Netherlands, 1090 HM
    • Onze Lieve Vrouwe gasthuis ( OLVG)
  • Breda, Netherlands, 4800 RK
    • Amphia ziekenhuis
  • Den Haag, Netherlands, 2512 VA
    • Medisch Centrum Haaglanden
  • Hoogeveen, Netherlands, 7909 AA
    • Bethesda Diabetes Research Center
  • Utrecht, Netherlands, 3543 AZ
    • St. Antonius Ziekenhuis
• Spain
  • Badalona, Spain, 8916
    • Hospital Germans Trias I Pujol
  • Gijon, Spain, 33206
    • Clinica Diabetologica
  • Vizcaya, Spain, 48903
    • Servicio de Endocrinología Hospital Unversitario Cruces
• Sweden
  • Falun, Sweden, SE-791 29
    • Falu Lasarett
  • Solna, Sweden, SE-171 76
    • Karolinska Universitetssjukhuset Solna
  • Stockholm, Sweden, SE-141 86
    • Karolinska Universitetssjukhuset Huddinge

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:

1. Diagnosed with Type 1 diabetes for ≥ 5 years
2. On their current insulin regimen for ≥ 3 months prior to study entry
3. Screening HbA1c result ≤ 7.5% (58 mmol/mol)
4. Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
6. Aged 18 years or over.

Exclusion Criteria:

1. Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
2. Subject is currently prescribed animal insulin
3. Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
4. Has known allergy to medical grade adhesives
5. Currently participating in another device or drug study that could affect glucose measurements or glucose management
6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
7. Currently using Sensor augmented pump therapy
8. Is planning to use a CGM device at any time during the study
9. A female subject who is pregnant or planning to become pregnant within the study duration
10. A breast feeding mother
11. Currently receiving dialysis treatment or planning to receive dialysis during the study
12. Has a pacemaker
13. Has experienced an acute myocardial infarction within previous 6 months
14. Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
15. Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
16. In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Blood Glucose Monitoring; Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.	Device: Standard Blood Glucose Monitoring; Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
Experimental: Sensor Based Glucose Monitoring System; Standard sensing system use for 6 months.	Device: Sensor Based Glucose Monitoring System; Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent <70 mg/dL	Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c at 6 Months	Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1	Baseline and Day 208
Time Spent <55 mg/dL and <40 mg/dL	Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL	Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194-208
Time Spent >180 mg/dL and >240 mg/dL	Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208
Time in Range	Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).	Baseline and Days 194 to 208
Number of Glucose Measurements Performed	Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.	Days 1 to 208
System Utilisation	System utilisation assessed by percentage of sensor glucose data collected by the intervention group	Days 15 to 208
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208	The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now). The ANCOVA adjusts for baseline DTSQs (status version).	Baseline and Day 208

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Principal Investigator: Stephan Matthaei, Diabetes Center Quakenbruck

Publications and helpful links

General Publications

• Rayman G, Kroger J, Bolinder J. Could FreeStyle Libre sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.
• Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.
• Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Sensing Technology; Type 1 Diabetes,
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: ADC-CI-APO-13019