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:

  1. New users of HDA experienced a significantly decreased risk of hypoglycemia after 12 weeks of use.

  2. 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

Hedia Diabetes 
Assistant Bolus Calculator significantly decreases risk of hypoglycemia:

A real-world new-user retrospective cohort study 

Overview

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

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, studies HDA

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, studies

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.

Clinical development plan, studies