Clinical Trial Results:
A single-centre, open-label, non-controlled trial of acceptance, usability, safety and efficacy of a tablet based workflow and decision support system with incorporated basal-insulin algorithm for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care
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Summary
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EudraCT number |
2018-000863-98 |
Trial protocol |
AT |
Global end of trial date |
30 Oct 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Oct 2021
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First version publication date |
27 Oct 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GlucoTab@MobileCare
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
German Clinical Trials Register : DRKS00015059 | ||
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Sponsors
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Sponsor organisation name |
Medical University of Graz, Univ. Prof. Dr. Thomas Pieber, Department of Internal Medicine, Division of Endocrinology and Diabetology
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Sponsor organisation address |
Auenbruggerplatz 15, Graz, Austria, 8036
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Public contact |
Sponsor contact, Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology, 0043 316385-72766, julia.kopanz@medunigraz.at
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Scientific contact |
Sponsor contact, Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology, 0043 316385-72766, julia.kopanz@medunigraz.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 May 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Oct 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Oct 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate the acceptance of the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice. All study participants were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Jul 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 9
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Worldwide total number of subjects |
9
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EEA total number of subjects |
9
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
1
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From 65 to 84 years |
6
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85 years and over |
2
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Recruitment
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Recruitment details |
Single-centre study - 1 site in Austria Recruitment started on 10-Jul-2018. Potential study participants were identified by domiciliary nurses of participating centers. Patients interested in the study were subsequently visited by one of the investigators. Altogether, 10 type 2 diabetes patients were included. | ||||||||||
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Pre-assignment
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Screening details |
From the 10 included patients, 8 completed the study according to study protocol, 1 was hospitalized (death) and 1 withdrew before any study related therapy had started. As the patient who got hospitalized had fulfilled the planned treatment duration, data was included for analyses. In total, data of 9 patients has been analyzed. | ||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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GlucoTab@MobileCare | ||||||||||
Arm description |
Insulin therapy with basal-insulin (Toujeo® Solostar®) was initiated and adjusted according to GlucoTab@MobileCare with incorporated basal-insulin algorithm. The goal of the basal-insulin algorithm was to maintain FBG within the FBG target according to the predefined health status. After start, basal-insulin was administered once daily in the morning. BG corrections with short acting insulin for very high BG values were performed using insulin glulisine Apidra® Solostar®. Capillary BG was measured by the nurses three times daily before meals at least for the first three days of the basal-insulin algorithm and only once in the morning when basal-insulin therapy had proven to be the suitable therapy regime (when BG values didn’t rise by more than 150 mg/dL compared to the FBG). For the long-term treatment, GlucoTab@MobileCare recommended one day with three pre-meal BG measurements once a month. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Toujeo 300 Einheiten/ml-Injektionslösung in einem Fertigpen
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Investigational medicinal product code |
ATC-Code: A10A E04
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Other name |
Toujeo®, Sanofi-Aventis (insulin glargine U300)
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Insulin dosage calculation was performed according to GlucoTab@MobileCare under supervision of the district nurses. If necessary, investigators could be contacted and reviewed the GlucoTab@MobileCare suggestion for correctness and plausibility. The insulin was administered sc via insulin pen by the nurses. Dosage was adjusted per individual patient requirements. Basal insulin was administered once daily.
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Investigational medicinal product name |
Apidra SoloStar 100 Einheiten/ml-Injektionslösung in einem Fertigpen
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Investigational medicinal product code |
ATC-Code: A10A B06
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Other name |
Apidra®, Sanofi-Aventis (insulin glulisine)
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
BG corrections with short acting insulin for very high BG values was performed according to GlucoTab@MobileCare suggestions. Correctional bolus insulin was administered at defined time-points according to BG targets in the predefined health status. The insulin was administered sc via insulin pen by the nurses. Dosage was adjusted per individual patient requirements.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
Insulin therapy with basal-insulin (Toujeo® Solostar®) was initiated and adjusted according to GlucoTab@MobileCare with incorporated basal-insulin algorithm. The goal of the basal-insulin algorithm was to maintain FBG within the FBG target according to the predefined health status. After start, basal-insulin was administered once daily in the morning. BG corrections with short acting insulin for very high BG values were performed using insulin glulisine Apidra® Solostar®. Capillary BG was measured by the nurses three times daily before meals at least for the first three days of the basal-insulin algorithm and only once in the morning when basal-insulin therapy had proven to be the suitable therapy regime (when BG values didn’t rise by more than 150 mg/dL compared to the FBG). For the long-term treatment, GlucoTab@MobileCare recommended one day with three pre-meal BG measurements once a month. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GlucoTab@MobileCare
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Reporting group description |
Insulin therapy with basal-insulin (Toujeo® Solostar®) was initiated and adjusted according to GlucoTab@MobileCare with incorporated basal-insulin algorithm. The goal of the basal-insulin algorithm was to maintain FBG within the FBG target according to the predefined health status. After start, basal-insulin was administered once daily in the morning. BG corrections with short acting insulin for very high BG values were performed using insulin glulisine Apidra® Solostar®. Capillary BG was measured by the nurses three times daily before meals at least for the first three days of the basal-insulin algorithm and only once in the morning when basal-insulin therapy had proven to be the suitable therapy regime (when BG values didn’t rise by more than 150 mg/dL compared to the FBG). For the long-term treatment, GlucoTab@MobileCare recommended one day with three pre-meal BG measurements once a month. | ||
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End point title |
The percentage of tasks (BG measurements, insulin dose calculations, insulin injections) that were performed according to GlucoTab@MobileCare with respect to all suggested tasks. [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
whole study duration
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: All parameters were analysed by descriptive and explorative statistical methods. No hypotheses were tested. The primary endpoint was: Percentage of tasks (BG measurements, insulin dose calculations, insulin injections) that were performed according to GlucoTab@MobileCare with respect to all suggested tasks. |
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| No statistical analyses for this end point | |||||||
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End point title |
Adherence to GlucoTab@MobileCare suggestions | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Mean adherence to suggested BG measurement frequency, basal and bolus insulin injection dose | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study duration, on weekdays only
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
BG values below individual target range | ||||||||||||||||
End point description |
altogether 25 BG values were below individual target
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of suggested/missed/performed insulin injections | ||||||||||||||
End point description |
Almost all 918 insulin injections suggested (1.2 ± 0.4) by the GlucoTab@MobileCare system were performed (n=914) (1.2 ± 0.4) and only four were missed (0.01 ± 0.07).
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Mean BG values in different day times | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study duration for "mean morning BG", first 3 treatment days only for the other endpoints
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of FBG values below/within/above FBG target range health status TIGHT | ||||||||||||||
End point description |
85 FBG measurements were taken in this group
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of FBG values below/within/above FBG target range health status MODERATE | ||||||||||||||
End point description |
491 FBG measurements were taken in this group
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of FBG values below/within/above FBG target range health status LOOSE | ||||||||||||||
End point description |
144 FBG measurements were taken in this group
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of morning (post-prandial) BG values below/within/above FBG target range health status TIGHT | ||||||||||||||
End point description |
no morning (post-prandial) BGs were taken in this group
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of morning (post-prandial) BG values below/within/above FBG target range health status MODERATE | ||||||||||||||
End point description |
14 morning (post-prandial) BGs were taken in this group
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of morning (post-prandial) BG values below/within/above FBG target range health status LOOSE | ||||||||||||||
End point description |
20 morning (post-prandial) BG measurements were taken in the group with health status loose
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of treatment days with morning BG or FBG values within FBG target range for health status TIGHT | ||||||||
End point description |
86 treatment days with FBG or morning BG measurements in this group
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of treatment days with morning BG or FBG values within FBG target range for health status MODERATE | ||||||||
End point description |
511 treatment days with FBG or morning BG measurements
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of treatment days with morning BG or FBG values within FBG target range for health status LOOSE | ||||||||
End point description |
166 treatment days with FBG or morning BG measurements in this group
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of treament days with BG values within the respective health-dependent target range | ||||||||||||||||
End point description |
Altogether 725 treatment days with FBG values, 38 treatment days with morning BG values (post-prandial), 123 treatment days with lunchtime BG values and 106 treatment days with dinnertime BG values.
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of treament days with BG values below the respective health-dependent target range | ||||||||||||||||
End point description |
Altogether 725 treatment days with FBG values, 38 treatment days with morning BG values (post-prandial), 123 treatment days with lunchtime BG values and 106 treatment days with dinnertime BG values.
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Mean insulin starting dose and mean insulin dose at last treament day | ||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
beginning and end of the treatment
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Overall percentage of BG values in pre-defined BG ranges | ||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Morning BG values grouped by study month | ||||||||||||||
End point description |
Aggregation was performed over all BG values of all patients in a certain period of time. 761 BGs that were taken in the morning were analyzed.
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Morning BG in different ranges | ||||||||||||||||||
End point description |
Aggregation was performed over all BG values of all patients in a certain period of time. 761 BGs that were taken in the morning were analyzed.
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End point type |
Secondary
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End point timeframe |
whole study duration
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events were assessed during whole study duration: Time range: 10.07.2018 (FPFV) – 30.10.2018 (LPLV)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23
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Reporting groups
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Reporting group title |
GlucoTab@MobileCare
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| short duration of study; no control-group; Insulin as pre-therapy | |||
