Clinical impact of Hedia Diabetes Assistant
We continuously conduct research and scientific studies to ensure Hedia Diabetes Assistant (HDA) has a positive impact on the lives of people with diabetes.
Discover the results from three retrospective studies conducted among our users in 2022, 2021, and 2020.
These studies showed positive outcomes that:
- New users of HDA experienced a significantly decreased risk of hypoglycemia after 12 weeks of use.
- Users of HDA with suboptimal glycemic control experienced improved stability of their blood glucose levels.
Study
Hedia Diabetes Assistant Bolus Calculator significantly decreases risk of hypoglycemia: A real-world new-user retrospective cohort study
Study
Changes in eA1C in a type 1 diabetes population after 41 weeks use of Hedia Diabetes Assistant: A real-world observational study
Study
Clinically relevant improvement in glycaemic control in type 1 diabetes users of the Hedia application for diabetes management: A real-world cohort study
Study
Patient-Reported Outcomes Among Users of Hedia Diabetes Assistant for Self-Management in Type 1 Diabetes
Study
Hedia Diabetes Assistant Bolus Calculator significantly decreases risk of hypoglycemia:
A real-world new-user retrospective cohort study
Overview
- HDA significantly decreases the risk of hypoglycemia.
- Hypoglycemia is a risk for everyone with insulin-requiring diabetes.
- Our recent study showed that using HDA decreases the risk of hypoglycemia without affecting eA1c after 12 weeks.
- HDA significantly decreases the risk of hypoglycemia.
Background and aims
Individuals living with type 1 diabetes are at risk of long-term complications related to chronic hyperglycemia. Tight glycemic control is recommended but can increase the risk of iatrogenic hypoglycemia. HDA is a bolus calculator that provides users with bolus insulin recommendations based on personalised settings. We aimed to investigate the effects of HDA on a known risk index of hypoglycemia.
Methods
In September 2022, user data was extracted from the HDA database. New users from 2019 to 2021 were included if they fulfilled the following criteria: Age ≥18 years old, ≥5 logs/1st week of use, and ≥1 log for glucose, carbohydrate, and insulin. The prespecified primary endpoint was a change in Low Blood Glucose Index (LBGI) after 12 weeks of use. Secondary endpoints were changes in High Blood Glucose Index (HBGI) and eA1c. An exploratory endpoint was maintaining potential improvements of LBGI after 25 weeks. Repeated-measures mixed model with log-transformation was used.
Results
A total of 1,342 users were included.
The mean age was 43.4 years (SD 14.7) with 52.3% female.
After 12 weeks, LBGI significantly improved from 0.73 to 0.61 (17% decrease, P<0.001; Figure 1) with no significant changes in HBGI, and eA1c (P=0.547 and P=0.594, respectively).
From week 12 to 25, LBGI decreased slightly from 0.61 to 0.55 (10%, P =0.107).
Conclusions
Users of HDA experienced statistically significant improved LBGI after 12 weeks, which was successfully maintained after 25 weeks with no changes in HBGI and eA1c. These results suggest a decreased risk of hypoglycemia when using HDA.
Watch our medical advisor Kenney present the study:
Ref: Pedersen KF, Østerskov A, Nielsen SM, Karagkounis G, Karnoe A. HEDIA DIABETES ASSISTANT BOLUS CALCULATOR SIGNIFICANTLY DECREASES RISK OF HYPOGLYCEMIA: A REAL-WORLD NEW-USER RETROSPECTIVE COHORT STUDY. Diabetes Technology and Therapeutics 2023;25:A-75
Study
Changes in eA1C in a type 1 diabetes population after 41 weeks use of Hedia Diabetes Assistant:
A real-world observational study
Overview
- HDA significantly improves eA1c and eTiR for poorly regulated users with T1D**
- We investigated the change in long-term glycaemic control among users of Hedia Diabetes Assistant after 41 weeks of use.
- The results showed significant improvements in eA1C and eTiR for poorly regulated users with T1D.
Background and aims
Smartphone-based bolus calculators have been shown to support glycaemic control in people with type 1 diabetes (T1D). However, little is known about the long-term effect of these in a real-world setting. We investigated the change in glycaemic control among users of HDA after 41 weeks use of the CE-marked bolus calculator.
Methods
In May 2021, data was extracted from the HDA database for users with ≥10 blood glucose logs per week for the first two weeks of use. The pre-defined outcomes were a change in estimated A1c (eA1c) and estimated time-in-range (eTiR, proportion of logged blood glucose values in range 3.9-10.0 mmol/l) from week 0 to 40. Data was analysed with GLMM for all users and for a subgroup of poorly regulated users (mean baseline BGL ≥10 mmol/l, eA1c≥7.9% in week 0).
Results
The sample contained anonymised data from 808 engaged HDA users with a mean age of 43.7 years (SD 15.9), including 407 (50.4%) females.
From week 0-40, mean eA1c increased with 0.13%-points (p=0.04) and eTiR decreased with 2.40%-points (p<0.01).
For poorly regulated users (n=299) the mean eA1c decreased by 0.51%-points (p<0.01) and eTiR increased by 6.95%-points (p<0.01).
Conclusions
The results showed significant improvements in eA1c and eTiR for poorly regulated users with T1D. Prospective, interventional studies are needed to further investigate the effect of smartphone-based bolus calculators.
**For poorly regulated users (n=299) the mean eA1c decreased by 0,51%-points (p>0.01) and eTirR increased by 6,95%-points (p>0.01).
Ref: Karnoe A, Jakobsen M, Nielsen S, Østerskov A, Gudbergsen H. CHANGES IN EA1C IN A TYPE 1 DIABETES POPULATION AFTER 41 WEEKS USE OF HEDIA DIABETES ASSISTANT: A REAL-WORLD OBSERVATIONAL STUDY. Diabetes Technology and Therapeutics 2023;25:A-206
Study
Clinically relevant improvement in glycaemic control in type 1 diabetes users of the Hedia application for diabetes management:
A real-world cohort study
Estimated A1c
HDA users experience significant improvements after 12 weeks of using HDA. Lower A1c indicates increasing control of blood glucose over time.
Estimated Time-In-Range
HDA users increase their estimated time-in-range in 12 weeks. Time-in-range shows the percentage of time a person is within its blood glucose target range.
Methods
A real-world study investigated changes in blood glucose control in people with type 1 diabetes after 12 weeks use of HDA. The dataset consisted of anonymised data from 234 engaged users, who had logged 10 or more blood glucose values per week for 12 weeks. The study looked into both the users as a whole, as well as a specific group of 84 users who had an estimated A1c of 7.9% or higher in their first week of using HDA.
Estimated A1c %
A decrease of 0.78% was detected in the group of more poorly controlled users.
A slight decrease in eA1c was detected in the group as a whole, over 12 weeks.
How was the A1c estimated?
A user enters their blood glucose levels into HDA; over time, HDA determines the average of those blood glucose levels. From this, we can get the “eA1c”: the estimated A1c.
Time-In-Range %
For the 84 users who initially had poor blood glucose control, we found a 12.35% improvement in estimated time-in-range after 12 weeks of using HDA.
Across all users, we saw a 2% average increase in time-in-range in 12 weeks use of Hedia Diabetes Assistant. This may indicate that HDA contributes to maintaining a well-controlled blood glucose level.
The range that we looked at was a blood glucose level between 3.9 and 10 mmol/L. This gave us the estimated time-in-range: the proportion of blood glucose measurements within that range.
Hedia Diabetes Assistant for all
Often, a digital divide might present itself between different groups of people. This study, however, is notably absent of any such digital divide regarding sex and age.
In other words, a person’s sex or age made no particular difference to the results: the same benefits appeared for all groups. This study showed HDA caters for all, regardless of sex or age.
Ref: A. Karnoe, M.O. Jakobsen, S.M. Nielsen, N. Ejskjaer, H. Gudbergsen. Clinically relevant improvement in glycaemic control in type 1 diabetes users of the Hedia application for diabetes management: a real-world cohort study, ATTD conference 2021, Diabetes Technology & Therapeutics, 23, A199.
Clinical development plan
In Hedia we always strive to collect high quality clinical data for Hedia Diabetes Assistant. Our current version of the product is CE-marked and available on the market and the physical exercise module is currently being investigated in a clinical trial.
Study
Patient-Reported Outcomes Among Users of Hedia Diabetes Assistant for Self-Management in Type 1 Diabetes
An Observational Real-World Study (PRO-1 Study)
Overview
- A 16-week follow up study of diabetes distress and perceived competence for diabetes management in new HDA users.
- Retention rate to the HDA and follow up assessment was low, and no differences in diabetes distrees and perceived competence for diabetes management were found.
Background and aims
It’s estimated that people with type 1 diabetes (T1D) make upwards of 180 health-related decisions a day. Despite substantial efforts from people with T1D, episodes of high and low blood glucose can often occur and cause frustration and diabetes-related distress that affects mental well-being. About 25% of people with type 1 diabetes suffer from diabetes distress. mHealth has potential to support stress relief in daily life in people with T1D, thus, the aim of the study was to determine if use of Hedia Diabetes Assistant (HDA) improved diabetes distress.
Methods
New users of HDA (≥ 18 years of age, with T1D, using multiple daily insulin injections, giving study consent) were included in the study. The primary outcome (diabetes distress) was measured with the validated patient-reported outcome measure on diabetes-related emotional distress; Problem Areas in Diabetes (PAID). The secondary outcome, perceived competence for diabetes management, was assessed by the validated questionnaire; Perceived Competence for Diabetes (PCD). Glycemic control was assessed using estimated A1c (eA1c, %) and estimated points in range (ePiR, %) calculated from data entries in HDA. All outcomes were assessed in the first week of HDA use and after 16 weeks of use.
Results
In total, 167 new users signed up to participate, and 94 of these provided consent and fulfilled the eligibility criteria.
Of these, 90 users completed the first questionnaires (week 1) and 58 participants completed the end of study questionnaires (week 16).
Furthermore, 18 users used HDA throughout the 16 weeks with a frequency that allowed for eA1c calculations.
A higher proportion of subjects than anticipated withdrew from the study; and the retention to the HDA during the study period was low (n=23).
Results (based on intention to treat analysis) showed no change in diabetes-related emotional distress (mean PAID score; 2.33 [95%CI -13.28 to 17.94, p = 0.744] from week 0 to week 16.
Furthermore, results for secondary outcomes showed no change from week 1 to week 16 (PCD score; -0.11 [95%CI, -6.28 to 6.06, p = 0.969], eA1c; 0.21(%-points) [95%CI, -2.07 to 2.50, p = 0.823] and ePIR; 8.43 (%-points) [95%CI, -22.56 to 39.41, p-value= 0.537]).
Conclusion
Due to low numbers of participants completing the study and low retention rate among participants the study is inconclusive. mHealth is often a cheap and easy-to-use method with good potential to support people with T1D to a less stressful life. Thus, further studies designed to accommodate real-world use of app-based bolus calculators are needed in order to investigate the effect of app-based bolus calculators on diabetes distress.